chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: Pt came in for a WCC visit and needed to receive Tdap, MCV4, HPV9, and Flu vaccines. Mom declined HPV9 and Flu vaccines. We do no have any Covid-19 vaccines at this time MA forgot to offer Tdap and told another MA to administer the shots she took out of our Vax machine. Those vaccines were Menquadfi and Bexsero. Bexsero should not have been administered. The second MA should have caught the fact that Tdap wasn't administered; and that the patient did not need Men B or Bexsero until the age of 16 yrs. Bother MA's made mistakes. The patient will be notified and we will schedule him to return for his Tdap vaccine that he did not receive.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Pain in extremity, Tenderness, X-ray limb
Clinical narrative: Patient received Tdap vaccine  at her recent PE.  Patient reported pain at injection site and in ability to move arm. Seen in UC on 10/23/24 for continued pain.  X-rays essentially negative and given anti-inflammatory for pain. Patient with continued pain and inability to fully use arm seen again in UC/Ortho on October 28, 2024 and it is felt that improper technique for vaccine administration led to acute bursitis.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Wrong technique in product usage process, X-ray limb normal
Clinical narrative: Patient received Tdap vaccine  at her recent PE.  Patient reported pain at injection site and in ability to move arm. Seen in UC on 10/23/24 for continued pain.  X-rays essentially negative and given anti-inflammatory for pain. Patient with continued pain and inability to fully use arm seen again in UC/Ortho on October 28, 2024 and it is felt that improper technique for vaccine administration led to acute bursitis.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Syncope
Clinical narrative: The patient collapsed, violent seizures or worst seizures; almost died; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Nov2024 as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) at the age of 27 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (ongoing). Concomitant medication(s) included: FELBATOL; APTIOM; XCOPRI; ONFI. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization; Bnt162b2 nos (DOSE 3 (BOOSTER)), for Covid-19 immunization; Bnt162b2 nos (DOSE 4 (BOOSTER)), for Covid-19 immunization. The following information was reported: SEIZURE (life threatening) with onset 16Nov2024 at 16:00, outcome "recovered" (16Nov2024 at 23:00), described as "The patient collapsed, violent seizures or worst seizures; almost died". The event "the patient collapsed, violent seizures or worst seizures; almost died" required emergency room visit. The clinical course was reported as follows: It was reported that the patient almost died from the booster vaccine she had on 16Nov2024. The patient underwent laboratory tests on 16Nov2024 because her parents had to take her to the emergency room (ER). They had to give her, her rescue medication called diazepam (VALTOCO) 15 milligrams and then the hospital kept her under observation for 6 and a half hours. The patient had the original Pfizer vaccine and this was her 5th Pfizer booster. The patient underwent the following laboratory tests and procedures: Laboratory test: (16Nov2024) Unknown results. Therapeutic measures were taken as a result of seizure.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Seizure
Clinical narrative: The patient collapsed, violent seizures or worst seizures; almost died; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Nov2024 as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) at the age of 27 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (ongoing). Concomitant medication(s) included: FELBATOL; APTIOM; XCOPRI; ONFI. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization; Bnt162b2 nos (DOSE 3 (BOOSTER)), for Covid-19 immunization; Bnt162b2 nos (DOSE 4 (BOOSTER)), for Covid-19 immunization. The following information was reported: SEIZURE (life threatening) with onset 16Nov2024 at 16:00, outcome "recovered" (16Nov2024 at 23:00), described as "The patient collapsed, violent seizures or worst seizures; almost died". The event "the patient collapsed, violent seizures or worst seizures; almost died" required emergency room visit. The clinical course was reported as follows: It was reported that the patient almost died from the booster vaccine she had on 16Nov2024. The patient underwent laboratory tests on 16Nov2024 because her parents had to take her to the emergency room (ER). They had to give her, her rescue medication called diazepam (VALTOCO) 15 milligrams and then the hospital kept her under observation for 6 and a half hours. The patient had the original Pfizer vaccine and this was her 5th Pfizer booster. The patient underwent the following laboratory tests and procedures: Laboratory test: (16Nov2024) Unknown results. Therapeutic measures were taken as a result of seizure.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Eyelid function disorder
Clinical narrative: Bell's Palsy on the left side; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's Palsy on the left side) (serious criteria GSK medically significant). The outcome of the bell's palsy was resolved (duration 4 months).   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     The company considered the bell's palsy to be unrelated to Shingrix.   Additional Information: GSK receipt date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she had received Shingrix vaccine. The reporter reported that he/she never had a reaction to any vaccine but this time he/she did. The patient experienced bell's palsy on the left side and it lasted almost four months and he/she could not close his/her eye lid.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 69.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Decreased appetite, Eye pruritus, Headache, Injection site swelling, Malaise
Clinical narrative: Fever 100.7°, itchy rash and severe swelling at injection site, body aches, headache, loss of appetite, itchy eyes, general malaise.
Age: 69.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Pain, Pyrexia, Rash pruritic
Clinical narrative: Fever 100.7°, itchy rash and severe swelling at injection site, body aches, headache, loss of appetite, itchy eyes, general malaise.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dysphagia, Dyspnoea, Oropharyngeal pain, Paraesthesia
Clinical narrative: Itching all over body and scratchy throat began around 4 hours post injection: took 25 mg Benadryl oral pill, contacted nurse advice line and itching progressed to burning sensation and tingling in fingertips, throat pain increased significantly causing difficulty to swallow and breathe. Took ambulance to hospital, was given solumedrol, Benadryl, Pepcid, and Tylenol via IV.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat irritation
Clinical narrative: Itching all over body and scratchy throat began around 4 hours post injection: took 25 mg Benadryl oral pill, contacted nurse advice line and itching progressed to burning sensation and tingling in fingertips, throat pain increased significantly causing difficulty to swallow and breathe. Took ambulance to hospital, was given solumedrol, Benadryl, Pepcid, and Tylenol via IV.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Dizziness, Tachycardia
Clinical narrative: 11:15pm, high body temperature for a few hours, (4),.. Tachycardia set in at 11:30pm, pulse was 120-130 got 7 hours,.. Dizziness, weakness in upper body. Drank fluids until 9am the following morning, symptoms went away slowly.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Hardness & redness at injection site. redness under skin.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: - Sensitivity & redness to injection site area. - Bruises at injection site
Age: 32.0
Sex: M
Vaccine: COVID19, FLUC4, TDAP
Symptoms: Amnesia, Dizziness, Loss of consciousness, Seizure
Clinical narrative: Patient requested for three vaccines and consciousness for about 5 seconds when I was giving the third vaccine on the right arm. he said he feels dizzy and then pass out for about 5 seconds and had short seizure.  He didn't remember what happened. I offered medical assistant but he denied. I asked him to stay in the pharmacy for 30 minutes and he felt better and was fine to leave.
Age: 12.0
Sex: F
Vaccine: COVID19, FLU3, HPV9
Symptoms: Loss of consciousness
Clinical narrative: After receiving the vaccines, after about 10 mins patient passed out.  Came to after about 30 seconds. She was given water and crackers and sat for 15 mins and was ok after.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Emotional distress, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient woke in the middle of the night with "extreme pain" in her arm she received the vaccination in that radiated up into her shoulder joint and neck and down to her elbow. Pain was significant enough to cause moderate distress.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Patient woke in the middle of the night with "extreme pain" in her arm she received the vaccination in that radiated up into her shoulder joint and neck and down to her elbow. Pain was significant enough to cause moderate distress.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: 22-year-old patient was vaccinated with Hep B designated for Birth to 19 years of age
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Biopsy skin, Hypersensitivity, Rash, Rash erythematous, Rash papular
Clinical narrative: Extremely red and itchy rash with hives under both armpits.  I went to the dermatologist and did not realize this was related to my RSV vaccine.  She prescribed the Prednisone 14-day treatment and also Trimcinolone Acetonide Cream.  The rash cleared up under my arms during treatment, but then it spread down both arms, down my back, on my stomach, in my crotch area.  Skin was hot to the touch and extremely itchy and raised bumps.  Scabs would come off during scratching.  I went back to the dermatologist after the spread and she has prescribed another round of Prednisone and ointment.  She did a biopsy of the hives.  She was treating me for a severe allergic reaction to something, but we had not determined what it was.  I looked at my calendar and realized that this might have been a reaction to the RSV vaccine.  I looked up adverse side effects and realized I was one of the rare cases of severe allergy.  It is now November 27 and I still have the itchy rash and new places.  I am hopeful that this second round of Prednisone will knock it down.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Rash pruritic, Scab, Skin warm, Urticaria
Clinical narrative: Extremely red and itchy rash with hives under both armpits.  I went to the dermatologist and did not realize this was related to my RSV vaccine.  She prescribed the Prednisone 14-day treatment and also Trimcinolone Acetonide Cream.  The rash cleared up under my arms during treatment, but then it spread down both arms, down my back, on my stomach, in my crotch area.  Skin was hot to the touch and extremely itchy and raised bumps.  Scabs would come off during scratching.  I went back to the dermatologist after the spread and she has prescribed another round of Prednisone and ointment.  She did a biopsy of the hives.  She was treating me for a severe allergic reaction to something, but we had not determined what it was.  I looked at my calendar and realized that this might have been a reaction to the RSV vaccine.  I looked up adverse side effects and realized I was one of the rare cases of severe allergy.  It is now November 27 and I still have the itchy rash and new places.  I am hopeful that this second round of Prednisone will knock it down.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Slight headache, Slight fever, Muscle aches and pain
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: SECOND DOSE OF FLU SHOT RECEIVED IN YEAR 2024. NO ADVERSE EVENT OCCURRED OTHER THAN A SECOND DOSE.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Inflammation, Injection site erythema, Local reaction, Pain
Clinical narrative: Pt reports she got her flu and PCV20 shot both in left arm 11/20. Reports a localized reaction on 11/25. Started as a red spot 2-3" an inch lower than injection site. On 11/26 increased to 5"x 2". Used Benadryl spray, started having localized pain and swelling.    Today (11/27)  has reduced in pain and inflammation.3" x 2". Feels it has improved.   RN rec antihistamine to help with reaction. Continue to monitor.  Pt agreed.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Gastrointestinal disorder, Myalgia, Pyrexia
Clinical narrative: Fever and muscle pain for 36 hours following the vaccine as well as 48 hours of on and off GI symptoms.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Condition aggravated, Seizure
Clinical narrative: Mom reports that pt had a seizure when they got to the car in the parking lot.  Waited 1 hour to call office to notify.  States this seizure is different that the ones she usually has.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis bacterial, Eye discharge, Eye pruritus, Eyelid margin crusting, Ocular hyperaemia
Clinical narrative: pt states her eyes started itching and turning blood shot red a couple of days after the flu vax. They started draining and became matted shut. She had to go to Urgent Care. Care on 11/16/24. Her DX was bacterial conjuctivitus. She was prescribed erythromycin 5mg to be given every 4 hrs for 7 days. This did not clear her eyes up at all. She went back to same Urgent Care on 11/24/24 and  was prescribed Ocuflox .3% drops. Her eyes are slowly responding to the medication. She now has scabs around her eyes and has been referred to her optimologist for further treatment. She will have to wait until next week since she does not have the copay for the visit.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Scab
Clinical narrative: pt states her eyes started itching and turning blood shot red a couple of days after the flu vax. They started draining and became matted shut. She had to go to Urgent Care. Care on 11/16/24. Her DX was bacterial conjuctivitus. She was prescribed erythromycin 5mg to be given every 4 hrs for 7 days. This did not clear her eyes up at all. She went back to same Urgent Care on 11/24/24 and  was prescribed Ocuflox .3% drops. Her eyes are slowly responding to the medication. She now has scabs around her eyes and has been referred to her optimologist for further treatment. She will have to wait until next week since she does not have the copay for the visit.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Eczema, Injection site reaction, Rash papular
Clinical narrative: eczematous/lichenified rash on b/l anterior thigh with discrete differentiation of rash area and normal skin. ordered triamcinolone ointment 11/27/24 for treatment.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Employee reported "body ache, fever, severe diarrhea, injection area red and hot at touch."  She (male sex/gender female) reports that she had a hive/urticaria at the sight of injection with itching and localized swelling.  After using an antihistamine, she report that the localized swelling and itching improved.  When she was seen on 11/21/2024, her left deltoid still had a little swelling and slight redness, but no urticaria, itching, and was not warm to touch.  She reported that her other symptoms of body ache, fever, and diarrhea completely resolved.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Employee reported "body ache, fever, severe diarrhea, injection area red and hot at touch."  She (male sex/gender female) reports that she had a hive/urticaria at the sight of injection with itching and localized swelling.  After using an antihistamine, she report that the localized swelling and itching improved.  When she was seen on 11/21/2024, her left deltoid still had a little swelling and slight redness, but no urticaria, itching, and was not warm to touch.  She reported that her other symptoms of body ache, fever, and diarrhea completely resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Head injury, Somnolence, Suture insertion
Clinical narrative: Resident husband felt resident was more sleepy and weak than normal and resident also had a fall on 11/20/24 which resulted in staples to back of head.
Age: 29.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Fall, Syncope
Clinical narrative: After patient received 2 vaccines, she walk out from vaccine room then she fall down on pharmacy floor. (within less than 2 minutes).  Patient was able to get up right way then sat down front of pharmacy for 30 minutes. After 30 minutes, patient felt better, left pharmacy. Per patient she had vasovagal syncope.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Back pain, Myalgia
Clinical narrative: patient reported 4 days later that she had malgia in left back down to thigh soon after vaccination. It has been dissapating slowly even with Tylenol each day for the pain. She did not see a doctor and feels like she will be fine in a couple more days.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: rash over his trunk and arms and  neck which occurred a few hours after getting his second dose of his hepatitis  A vaccine. Pt was also fussy and borderline febrile
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush
Clinical narrative: Felt intense hot flush starting from her abdomen and it traveled to her upper chest. She noticed that flush after receiving the vaccine. The intensity of the flush was felt more during the night as she was trying to sleep. This morning the intensity has "greatly" lessened but the flush is continuing.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cardiac failure, Oedema peripheral, Oxygen saturation decreased, Urinary tract infection
Clinical narrative: wheezing and edema in bilateral legs,  low O2 sAP-8ats at 84% on RA. She was wheezing BP was 150/90 AO-82 P-22 and Temp- was 101.2, sent to ER and admitted with heart failure and UTI.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: wheezing and edema in bilateral legs,  low O2 sAP-8ats at 84% on RA. She was wheezing BP was 150/90 AO-82 P-22 and Temp- was 101.2, sent to ER and admitted with heart failure and UTI.
Age: 75.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain, Pyrexia, Wrong product administered
Clinical narrative: Patient came in wanting RSV vaccine and Shingrix was inadvertently administered instead. He indicated he had some achiness and fever that evening into the next day. He is fully recovered with no long lasting effects.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Sinusitis
Clinical narrative: Sinus infection
Age: 51.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Cold sweat, Dizziness, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: Spoke to pt. She received 2nd shot shingrix and 2nd shot Heplisav 11/26. Reports reaction from 1st dose for both, given on same day 8/27/24.  She had felt very exhausted and nauseous. Faded by midday after the shot.    Reports she woke up at 2a, got an intense head rush, dizziness, nausea, cold clammy sweats. She needed to lay down on the floor when she was enroute to the bathroom until dizziness and nausea passed.    As of this morning, she is getting sharp pings of intense pain to her head. Feels achy and exhausted.    Site of injection has some pain making it difficult to raise arm to 90 degrees. Very painful to light touch.  No warmth, no swelling, no redness to site. Sweating has resolved, nausea starting to resolve and dizziness mostly resolved.   Difficulty tolerating food and drink.  Unsure if she is running a temp, has a thermometer.   Reports this is sig worse then the first dose. She had felt very exhausted and nauseous. Faded by midday after the shot.   She took ibu last night prior to bed.   RN rec BRAT diet, warm fluids.  Take temp. Can take a tyl to help w pain and HA. Monitor and report any worsening.
Age: 51.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site pain, Nausea, Orthostatic hypotension, Pain
Clinical narrative: Spoke to pt. She received 2nd shot shingrix and 2nd shot Heplisav 11/26. Reports reaction from 1st dose for both, given on same day 8/27/24.  She had felt very exhausted and nauseous. Faded by midday after the shot.    Reports she woke up at 2a, got an intense head rush, dizziness, nausea, cold clammy sweats. She needed to lay down on the floor when she was enroute to the bathroom until dizziness and nausea passed.    As of this morning, she is getting sharp pings of intense pain to her head. Feels achy and exhausted.    Site of injection has some pain making it difficult to raise arm to 90 degrees. Very painful to light touch.  No warmth, no swelling, no redness to site. Sweating has resolved, nausea starting to resolve and dizziness mostly resolved.   Difficulty tolerating food and drink.  Unsure if she is running a temp, has a thermometer.   Reports this is sig worse then the first dose. She had felt very exhausted and nauseous. Faded by midday after the shot.   She took ibu last night prior to bed.   RN rec BRAT diet, warm fluids.  Take temp. Can take a tyl to help w pain and HA. Monitor and report any worsening.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is currently 32 weeks pregnant. Unkown of any other information to pregnancy.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt fainted during vaccine twice.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: PATIENT HAS PAIN AT ADMINISTRATION SITE ONE MONTH LATER
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Blood test normal, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache,  diarrhea, predominantly sore-muscle of joints (intermittent) attacking ankle, wrist, knees. Trouble sleeping due to pain.  Patient is very fatigued and weak.   Patient taking Tylenol arthritis , advil and mobic as needed.  Diarrhea has gotten better, headache and fatigue still persist.  Sometimes  gravity worse than before.
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: Insomnia, Myalgia, Pain
Clinical narrative: Headache,  diarrhea, predominantly sore-muscle of joints (intermittent) attacking ankle, wrist, knees. Trouble sleeping due to pain.  Patient is very fatigued and weak.   Patient taking Tylenol arthritis , advil and mobic as needed.  Diarrhea has gotten better, headache and fatigue still persist.  Sometimes  gravity worse than before.
Age: 52.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reaction reported by patient. On November 24 we realized the patient showed up  early on the 22nd and receive all 3 second doses of her vaccines.  She was scheduled in the system for 11/24. As a result the patient receive all 3 doses on day 27 instead of 28 of her schedule
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cough, Influenza virus test negative, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Cough, sore throat,, congestion, body aches
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Cough, sore throat,, congestion, body aches
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was assigned a beyond use date of 11/16/24 after placing in the refrigerator.  We inadvertantly gave product that was past its assigned BUD.  No adverse effects identified, however, will need to reschedule a vaccination.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: swollen and red at the injection site - turned black and blue over the upcoming days, WARM TO THE TOUCH.  The patient then complained of severe fatigue, Headaches, and also a swollen gland on the left side of her neck.  RPh recommended calling her physician to report the adverse event, however the patient remained calm and simply took a couple consecutive 8HR doses of Tylenol 650mg and the adverse reaction began to improve over the next could days.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Lymphadenopathy
Clinical narrative: swollen and red at the injection site - turned black and blue over the upcoming days, WARM TO THE TOUCH.  The patient then complained of severe fatigue, Headaches, and also a swollen gland on the left side of her neck.  RPh recommended calling her physician to report the adverse event, however the patient remained calm and simply took a couple consecutive 8HR doses of Tylenol 650mg and the adverse reaction began to improve over the next could days.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: the vaccine was assigned a BUD of 11/16/24 due to storing in the refrigerator.  Administered vaccine past its BUD.  Will need to re-vaccinate
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: About 2 days after receiving the vaccine, the patient starting to feel itching on her right side, then a rash developed and started becoming more painful after several more days.  Patient showed me the rash on 11/26/24 and it appeared to look like a shingles rash. I recommended the patient to follow up with her doctor. Patient saw her provider on 11/26/24 who prescribed valtrex and antihistamines.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: We administered a dose that was past its assigned BUD.  We assigned a BUD of 11/16/24 after moving  the vaccine from the Freezer to the refrigerator.  Will need to re-vaccinate
Age: 11.0
Sex: F
Vaccine: COVID19, HPV9, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: None gave 12+ instead of 6m - 11 yr
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram head, Dizziness, Limb discomfort, Nausea
Clinical narrative: C/o dizziness, lightheadedness, heaviness to B/L legs, and nausea (no vomiting). Has history of Guillain Barre diagnosis from flu vaccination done 10 years ago.
Age: 0.92
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was here for a nurse visit to receive flu vaccine. Patient asked for egg free flu vaccine. Educated on the importance of receiving the regular flu vaccine even with sensitivity to egg. Mom was still persistent of receiving egg free vaccine. Grabbed egg free vaccine and scanned the vaccine, a "hard stop" popped up, nurse who scanned vaccine interpreted hard stop as a notification of being able to take the normal flu vaccine versus age discrepancy to receive vaccine. Patient was then given egg free version of vaccine on 10/29/24. Patient then came for well child check on 11/25/24. Provider noted that the child was to receive a second influenza vaccine because they had only ever received one previously. Provider noted that child had received flublok which is a 18+ vaccine. Patient's parents aware of incorrect vaccine being given. Patient received regular second influenza vaccine .
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neck pain
Clinical narrative: On 11/19/24 pt received the covid19 Spikevax vaccine in the RIGHT deltoid muscle. Pt came into pharmacy a week later to report they had extreme stiffness and pain/muscle cramp on LEFT side of neck approximately 3-4 inches long going up/down. We advised the patient that we do not think it was from the vaccine because they were opposite sides (not 100:/: but not likely related), but informed them that I would make a report regardless and that the patient needs to followup with a doctor for further examination. Patient then spoke to store director and was given a phone number for corporate.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Syncope
Clinical narrative: Patient received both vaccines and fainted shortly after while still seated. 911 was contacted and provided care.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Dyspnoea, Erythema, Fatigue
Clinical narrative: Trouble breathing within 15 minutes. Longer term, pain in arm, redness in whole face underarm pain, muscle soreness, joint soreness, fatigue.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Trouble breathing within 15 minutes. Longer term, pain in arm, redness in whole face underarm pain, muscle soreness, joint soreness, fatigue.
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Underdose
Clinical narrative: 6 month to 11 yo Covid-19 Moderna vaccine wrongfully administered.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is only 17 but was given heplisav B (indicated for 18 and older)
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient administered KINRIX.  Patient to receive Dtap only.   No adverse reaction.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash, Rash erythematous, Rash papular
Clinical narrative: PER CLIENT, ONSET OF RED RAISED BUMPS OCCURRED APPROXIMATELY 0930 ON 11/20/24. ITCHING AND RED RAISED BUMPS PROGRESSED DOWN LEFT ARM THROUGHOUT THE REST OF THE DAY AND INTO THE EVENING-MOSTLY GENERALIZED TO LEFT BICEP AREA TO BELOW LEFT ELBOW. AREA HAD RED RAISED BUMPS AND SURROUNDING SKIN RED AND WARM TO TOUCH. NO TREATMENT AT TIME OF REPORTING TO HEALTH DEPARTMENT NURSING STAFF, BUT PLANS ON USING OTC BENARYL SPRAY. ENCOURAGED TO ALSO REPORT TO PCP.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: PER CLIENT, ONSET OF RED RAISED BUMPS OCCURRED APPROXIMATELY 0930 ON 11/20/24. ITCHING AND RED RAISED BUMPS PROGRESSED DOWN LEFT ARM THROUGHOUT THE REST OF THE DAY AND INTO THE EVENING-MOSTLY GENERALIZED TO LEFT BICEP AREA TO BELOW LEFT ELBOW. AREA HAD RED RAISED BUMPS AND SURROUNDING SKIN RED AND WARM TO TOUCH. NO TREATMENT AT TIME OF REPORTING TO HEALTH DEPARTMENT NURSING STAFF, BUT PLANS ON USING OTC BENARYL SPRAY. ENCOURAGED TO ALSO REPORT TO PCP.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient was given the ADULT dose of Pfizer and is only 11 years old
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: GUARDIAN STATED THE PT HAS A DIME SIZE KNOT IN THE AREA OF THE INJECTION THAT FELT LIKE A HARD BALL, THERE WAS NO RASH BUT IT WAS WARM TO THE TOUCH.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was under 18 and received 1st dose of heplisav
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Rash papular
Clinical narrative: AROUND 7PM ON 11/26/24 CASE REPORTED AN ACHING, PRICKLY SENSATION ALL OVER BODY AND NOTICED A MOSTLY FLAT  RASH WITH A FEW RAISED BUMPS ALL OVER BODY. TOOK 25MG PO BENADRYL. NO OTHER SYMPTOMS, RESOLVED BY MORNING THE FOLLOWING DAY 11/27/24. ENCOURAGED CASE TO ALSO REPORT TO PCP SINCE THIS WAS THE FIRST INJECTION IN A SERIES OF 2.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Malaise, Nausea, Pruritus, Pyrexia
Clinical narrative: Patient reported today of redness and itching stretching around her left arm.  Patient also stated going home on 11/21/24 and starting not to feel well.  Patient stated to have slight fever and experience nausea throughout the night on 11/21/24.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20, RV1
Symptoms: Body temperature increased, Breath holding, Crying, Hypotonia, Infant irritability
Clinical narrative: Pt received vaccine, held in their breath and then started crying. Parent fed pt and then pt had color drain from their body,  turn yellow, stopped, crying, and became flacid. LPN went and got NP and Doctor to look at baby. Pt was placed on the table, assessment was made, circulation and perfusion were checked. Baby started babbling and moving around more after 5 minutes. Vitals were taken and were stable. Followed up by calling patient the day after. Parents stated they were fussier and ran a low temp, but no other adverse effects.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20, RV1
Symptoms: Pallor, Yellow skin
Clinical narrative: Pt received vaccine, held in their breath and then started crying. Parent fed pt and then pt had color drain from their body,  turn yellow, stopped, crying, and became flacid. LPN went and got NP and Doctor to look at baby. Pt was placed on the table, assessment was made, circulation and perfusion were checked. Baby started babbling and moving around more after 5 minutes. Vitals were taken and were stable. Followed up by calling patient the day after. Parents stated they were fussier and ran a low temp, but no other adverse effects.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: 3 hours after vaccination, patient developed red rash on left leg, groin, chest thigh and waist. no swelling of tongue, difficulty breathing, shortness of breath or difficulty swallowing. parents called triage RN and were instructed to give benadryl. within several minutes reaction improved.
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The patient was given an additional prevnar 20 dose on 11/12/24 after they had received the vaccine on 9/2/24
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back injury, Fall, Muscular weakness
Clinical narrative: Vaccine administered at 11:30 am, patient left the room. Patient was in lobby and experienced weakness legs and attempted to sit in chair but missed. She hit her back on chair and landed on floor. Patient was taken by wheelchair back to room where she was given water and ice pack. Provider came and evaluated patient and vitals where taken. Vitals were within normal parameters. Patient left feeling okay with parent.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Syncope
Clinical narrative: Patient was administered  a dose of Flucelvax 24-25 formula and within 5 minutes had an episode of syncope. He quickly came out of it and was given water and an icepack. His mom stated that this has happened to him in the past.  After having him sit for 20 minutes his color was back and he was able to stand and leave the pharmacy with his mom and dad.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The patient was given an additional prevnar 20 dose on 11/12/24 after they had received the vaccine on 9/2/24
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: on 11/27, patient came to pharmacy stating pain and redness in arm still from 11/24.  Area of injection red, swollen and  larger than palm of hand. Patient claims it is better than it has been last few days.
Age: 60.0
Sex: F
Vaccine: COVID19, PNC21, RSV, VARZOS
Symptoms: Chills, Hypersomnia, Lethargy, Pyrexia
Clinical narrative: Patient received 4 vaccines on 11/19/24 and the next day experienced fever of 103.8 and felt extremely lethargic. She slept for about 18 hours and woke up next morning feeling OK.  Fever had subsided, but she still had chills.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Nonw
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Nonw
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED 12 DAYS PRIOR TO ADMINISTRATION DATE. PARENTS REPORTS CHILD TO HAVE NO ADVERSE REACTIONS.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered past the expiration/beyond-use-date
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of Varicella vaccine, one in the Proquad and one single Varicella dose.
Age: 69.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Bursitis, Pain in extremity
Clinical narrative: I had the sore arm come on by the next day which I expected but it ended up being in the bursa and a severe pain since then.  The pain goes down my arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: I got a call from an insurance company in regards to an adverse effect of a vaccine that patient was reporting. Patient was also on the call with insurance company and reported having some side effects after receiving Covid vaccine (Spikevax 2024-2025).  Patient DOB 07/xx/19xx received Covid vaccine on 10/12/2024 has been having issues ever since. At first she experienced normal side effects like sore arm for couple of days but she started having pain in left shoulder that radiated to the right shoulder. She started having wrist pain as well and left ankle pain. She was seen by Dr. and was given an ibuprofen prescription but she has been taking Tylenol instead due to her history of anemia. I asked patient if any imaging was ordered by the doctors and she reported none. She was advised to see a physical therapist for a rotator cuff tendinitis.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Within 2-3 weeks of receiving 2024-2025 COVID vaccine, pt began experiencing new onset generalized hair loss from scalp. Exam did not demonstrate significant strand breakage nor patches, but rather was consistent with generalized progressive alopecia
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: THERE WAS NO ADVERSE REACTION
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Abdominal pain, COVID-19, Cholelithiasis, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: 6 wks following boosters Went into ER for abdominal pain. Also had apparent respiratory illness for past 4 days. Dx with gall stones. Swabbed for covid prior ti surgery. Positive test. Date 11-24-2024
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: Dose administered past the expiration/beyond-use-date
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 year old female received 3rd dose of Dtap on 11/25/2024, mother states few hours after going home mother noticed the redness and swelling on the patients arm. Mother called the Provider office on 11/27/2024 at 1:29 pm.  Per provider no systemic reaction concern at this time. Patient is to Ice area as tolerated and apply Hydrocortisone 2.5% for itching. Outline with marker, follow up  Monday but if redness spreads beyond the borders over Holiday weekend, she is to attend urgent care/ER also ER precautions for sudden SOB, fever , swelling , etc provided.
Age: 0.58
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: No additional AE; Nurse states that a 7 month old patient was due for their 3rd dose of ROTATEQ and was accidently given ROTARIX; This spontaneous report was received from a nurse referring to a 7-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 31-OCT-2024, the patient was vaccinated with rotavirus vaccine live oral 1v (ROTARIX), administered for prophylaxis (strength, formulation, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) accidently instead of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (strength, lot #, expiry date, dose, and route of administration were not provided) (Wrong product administered). No additional information. No additional adverse event (AE) (no AE).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Caller stated no patient symptoms have been reported. No additional AE; administered a dose of MMR II to a patient that was reconstituted with the DILUENT for SHINGRIX instead of the Merck DILUENT.; This spontaneous report was received from Pharmacist and refers to a patient of unspecified age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 23-NOV-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, lot #X026222, expiration date: 06-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) that was reconstituted with the DILUENT (not further information) for SHINGRIX instead of the Merck sterile diluent (Product preparation error). It was informed that no patient symptoms have been reported. No additional Adverse event no product quality complaint reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID INFECTION; COVID INFECTION; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-Fosun-2024FOS000416.  A female patient with unknown age received 3rd Tozinameran (COMIRNATY) via unknown route at unspecified dosing frequency for COVID-19 immunization on an unknown date. The 1st and 2nd doses were received on unknown dates. Medical history, concomitant medication(s) and past product for the patient were not reported. Following 3rd shot, the patient got COVID infection 3 weeks later. Unknown Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was 8 weeks pregnant and the Dr was recommending 4th COVID dose. At the time of vaccine administration, the patient was in another country. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient was tested for COVID-19 since vaccination. The event COVID-19 infection was not serious. The actions taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was resolved. Initial report was received on 08-Nov-2024. Follow-up closed, no further information is possible.  COMIRNATY is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400311460 same patient same vaccine different dose/AEs;
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Extreme nerve pain entire back to hips; This non-serious case was reported by a consumer and described the occurrence of nerve pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-MAY-2024, the patient received Shingrix. On 28-MAY-2024, 6 days after receiving Shingrix, the patient experienced nerve pain (Verbatim: Extreme nerve pain entire back to hips). The outcome of the nerve pain was not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.     It was unknown if the company considered the nerve pain to be related to Shingrix.   Additional Information: GSK receipt date: 29-OCT-2024 The patient experienced extreme nerve pain entire back to hips from 28th May 2024 and it was ongoing.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant patient received Arexvy instead of Abyrsvo.; Pregnant patient received Arexvy instead of Abyrsvo.; Wrong vaccine administered; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant patient received Arexvy instead of Abyrsvo.), product use in unapproved population (Verbatim: Pregnant patient received Arexvy instead of Abyrsvo.) and wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the vaccine exposure during pregnancy, product use in unapproved population and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 12-NOV-2024 Other HCP reported that pregnant patient received Arexvy instead of Abyrsvo, which led to vaccine exposure during pregnancy and drug use in unapproved population. Reporter was notified from local health department but did not had details. Reported told local health department to report to VAERS. Reporter also checked GSK's website to see if there was a pregnancy registry program.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Priorix was administered to patient after stored improperly; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received MMR (Priorix) (batch number 9KB9L, expiry date 05-OCT-2026) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Priorix was administered to patient after stored improperly). The outcome of the incorrect storage of drug 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: 28-OCT-2024 The HCP (health care professional) reported that a dose of Priorix vaccine was administered to a patient after stored improperly (20.8 degree C for 1 hour 28 minutes 0 seconds), which led to an incorrect storage of drug. No side effects or symptoms reported, also, no additional information was provided. No additional adverse event or no PQC (pharmaceutical product complaint) was reported. The reporter reported that, there was no prior excursions and product was back in range.