chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was administered a Pfizer covid vaccine when an influenza vaccine was requested. Pt stated that he already received a Moderna vaccine earlier that day at a different pharmacy. (Unlisted in database at time of vaccination and time of report.) Both covid vaccines were given in the right arm. The influenza vaccine was administered after the error was discovered, but in the left arm to keep it separate. No adverse outcomes at time of report.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Pain, Pyrexia
Clinical narrative: Body aches, weakness, fever 100.1 and lightheadeness. Still feel a little  weak. Took only Tylenol.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Pain, Pyrexia
Clinical narrative: Body aches, weakness, fever 100.1 and lightheaded. Still feel a little weak. Has only taken Tylenol.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Wrong product administered
Clinical narrative: Patient had requested this year's influenza vaccine for the fall of 2024. RN sat down with the patient and verified patient's name and date of birth and vaccine. RN prepped the site with an alcohol swab and used an 'inject safe barrier bandage- injection site bandage' to mark and bandage the area for administration. RN gave the vaccine and as soon as she went to retract the needle, she realized she had given the '24-'25 Pfizer COVID vaccine. RN immediately told the patient what happened and apologized for this. RN answered all questions from patient and assessed the patient for any symptoms, concerns, previous issues with the COVID vaccine or reactions from the COVID vaccine in the past. Patient denied all initially. After getting the vaccine patient put her sweatshirt back on. RN went on to appropriately give patient's mother the influenza vaccine without issue. RN apologized again and asked patient and mother to wait for just a minute while I let the pharmacy manager know what happened. RN went to tell Pharm D. the situation that happened. Pharm D. confirmed we did not need anything further from the patient and that the patient could leave when they were ready and RN and Pharm D. would do the paperwork to get things corrected on the back end as well as fill out the appropriate reports. RN then went to let the patient know that we didn't need anything more from her and she had moved from standing to sitting on the chair stating she felt queasy. I let her know this would be unlikely from the vaccine administration as typically symptoms do not show so quickly but that I wanted to monitor her for a few minutes before she left. RN did notice that the injection room here was higher temperature (this was shared with RN upon arriving as well by Pharm D.). RN asked the patient if she felt comfortable enough to stand up and walk a short distance as there were a few chairs and a water fountain nearby. RN instructed patient to take a drink of water from the water fountain and sit down for a moment and I would be back in just a few minutes to check on her. RN assessed patient for dizziness/lightheadedness before letting her step outside of the room. Patient was comfortable doing so and stepped outside the room safely. RN discussed next steps with Pharm D and made a plan for the appropriate paperwork so the patient could get her true influenza vaccine when she felt comfortable coming in again. RN went back to check on the patient and apologized again. Patient and mother stated she "felt just fine" and that she "just needs something to eat as it has been awhile." Patient and mother were understanding and stated they would be back for the influenza vaccine in a week or so.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Device connection issue, Exposure via skin contact, Syringe issue
Clinical narrative: syringe  malfunction.  Needle was not attached to syringe properly (not screwed in) when administering vaccine, all the serum ran out of the end of the syringe(not through the needle) and the solution ran down the patients arm.
Age: 0.5
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were NO Adverse reactions. This was the adult dose meant for 60 years and over. This information is not written anywhere on the packaging.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient states that he and his wife received a vaccination 10/11/24 and when they got up the morning of 10/14/24 they both had large red/pink welts at the injection site. Patient has not treated as of yet. Advised to keep an eye on the site and follow up with PCP as needed.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Patient states that he and his wife received a vaccination 10/11/24 and when they got up the morning of 10/14/24 they both had large red/pink welts at the injection site. Patient has not treated as of yet. Advised to keep an eye on the site and follow up with PCP as needed.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Injection site rash that is around 4 inches in diameter which is red, inflamed (hot to the touch), tender and itchy. The reaction started with the some soreness and bruising after the injection. The next day,  it had turned into  a rash around the injection site. By 72 hours after the shot, the expected arm soreness had resolved, but the rash was still present. Today the redness is starting to reduce, but the itching is still present.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Injection site rash that is around 4 inches in diameter which is red, inflamed (hot to the touch), tender and itchy. The reaction started with the some soreness and bruising after the injection. The next day,  it had turned into  a rash around the injection site. By 72 hours after the shot, the expected arm soreness had resolved, but the rash was still present. Today the redness is starting to reduce, but the itching is still present.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to be getting Tdap and not Dtap.  The vaccine was gotten from the Vaccine fridge with help from another MA. I took the vaccine sheet and vaccines to the provider for them to verify before giving patient the shots. Provider Verified that vaccines were correct. Gave patient the shots. Noticed after trying to put the vaccines in the system that the wrong shot was given
Age: 75.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Patient had muscle aches an hour after the vaccinations. She reported the muscle aches became severe and did not improve until after 3 weeks. She is unable to fully lift both arms from the day she received the vaccine up to the time of reporting. The muscle aches is now mild in severity and has not gone away completely. She has not seen a doctor for the reported reactions/adverse event.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: The patient ended up with a bruise at the injection site. Was told to ice the spot several times daily and to see  her doctor if it does not improve with 3 days
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypotonia, Nausea, Somnolence, Vomiting
Clinical narrative: Patient was drowsy, her body was limp, she was light headed and nauseous. Patient vomited. All this happened about 10 minutes after the vaccine was given. After checking the patients blood pressure, she was instructed to lay down on a bench and put her feet up. Quickly after that she felt better.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Flu vaccination was given in Right Deltoid using correct technique and patient left without any complaints. Later that evening (Saturday  10/12, the patient called stating that her right arm was hurting and it hurt to use it. Given the information provided I communicated to her that arm tenderness after a vaccination is normal, but if she would like she can take Tylenol for the pain and apply ice to the area. Patient then presented to the pharmacy on 10/14 and showed her arm that was visibly bruised and slightly swollen from her deltoid down to her mid-forearm. Patient then stated that she did not realize until she was getting ready for bed on 10/12 that she was bruised and the bruising progressed since then. She also stated that she spoke to a nurse before she came in (10/14) and described the situation and the nurse again told her to take Tylenol for the pain and to ice the area. The nurse also recommended that she come back in to the pharmacy and show me the bruising so I could make a report. I recommended to the patient that she try to get her arm looked at to make sure there was nothing additional her provider would recommend since it was difficult to understand the scope without seeing her arm. I asked her to call back with any additional information provided by her PCP/nurse once she got her arm checked out. At this time the patient has not called with additional information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraplegia
Clinical narrative: Patient received shot and she felt fine, 15 minutes later the husband called and said she had severe pain everywhere and had paralysis from the chest down.  The patient's husband had also called EMS.  I told him to call me back and keep me update on her situation.   He called 15 minutes later and said she was better.  The pain disappeared and she was walking.  The dispatcher told him she was fine and if they wanted to go to ER just to get checked out.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Vertigo
Clinical narrative: Pt said she had vertigo after vaccination, vertigo is resolved and now she has brain fog
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal discomfort
Clinical narrative: diswcomfort in right are and shoulder
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Very red, warm, sore and itchy spot on arm at the site vaccine was given. I ve tried lotions and creams and ice packs with no results. Tonight I ve tried Benedryl gel and oral Benedryl.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Erythema, Eye pain, Headache
Clinical narrative: Covid arm  with a hot large red bump about 4-5 inches in a lump with hot pain and sensitivity.  Also my eyes hurt, I have a headache and my joints are achy.  I also feel tightness in my chest.  Lethargic
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Lethargy, Limb mass, Pain in extremity, Skin warm
Clinical narrative: Covid arm  with a hot large red bump about 4-5 inches in a lump with hot pain and sensitivity.  Also my eyes hurt, I have a headache and my joints are achy.  I also feel tightness in my chest.  Lethargic
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Covid arm  with a hot large red bump about 4-5 inches in a lump with hot pain and sensitivity.  Also my eyes hurt, I have a headache and my joints are achy.  I also feel tightness in my chest.  Lethargic
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient states she started with redness and swelling at the injection site on 10/12. The area became very red, swollen, and hot to the touch. The patient also stated she had a headache that would not go away.  Patient states the injection was given too high and with a smaller than normal needle. Patient went to the doctor and was placed on antibiotics due to an infection at the injection site.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Tinnitus that started a few hours after the vaccine and hasn't stopped yet! Other side effects are mild and have resolved (fever, arm pain, fatigue). Tinnitus hasn't happened with previous vaccinations. This is by far the worse side effect and it isn't going away yet.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood pressure increased, Chest discomfort, Feeling abnormal, Feeling hot
Clinical narrative: The patient left the vaccination room, and 1 minute later her daughter said that her mom is not feeling good. The patient said that she had a sudden tightness in her chest, worm feelings in her scalp and neck, and severe back pain.  We called 911 ASAP. The EMS team said that she had an elevated blood pressure, which went down later.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Calcinosis, Chondrocalcinosis, Joint swelling, X-ray abnormal
Clinical narrative: Severe and extreme left wrist pain and swollen. Xray discover calcium crystal deposits along left ulnar styloid. I never knew I have pseudogout. Never had attacks or flares. This is my first time. After Nsaid and steroid treatment. I was sent home with colchicine. I was better for 1 night. 2 days later it came back stronger. Went back to ER, treated intravenously with narcho and steroid drugs. Sent home with 1 week prescription with prenisone, 800 mg ibuprofen a a few natcho drugs. After 1 week, the pain subsides a bit and the swelling goes down. I found no report online regarding pseudogout attack by mrna covid vaccine. I report it to warn others and I will not have covid or mrna vaccine ever again. I was so painful that i rather have my arm cut off. The pain level is 100 on the scale of 1 to 10.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Dizziness following vaccine, little shortness of breath
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant swelling, redness and pain after injection. Injection reaction still present 3 days later. Patient returned to clinic d/t concern over prolonged reaction.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Nausea, Respiratory distress, Retching, Stridor
Clinical narrative: Patient fell in the lobby, patient was alert, stated she did not hit her head. Appeared to be nauseous. Trash can and emesis bag was given. Dr. arrived on the scene. Pt was dry heaving, but no actual vomit. Pt then developed into respiratory distress with audible stridor. Epi 0.3 was given @ 11:44 am and Albuterol. 11:47 am second dose Epi given. Patient stated feeling better. EMS showed up.
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: itchy rash all over in torso, arms and legs that is not going away; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27Y) for prophylaxis.   Previously administered products included tetanus, diphtheria, pertussis vaccine (Patient received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago.).   On 19-AUG-2024, the patient received Boostrix. On 20-AUG-2024, 1 days after receiving Boostrix, the patient experienced itchy rash (Verbatim: itchy rash all over in torso, arms and legs that is not going away). The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the itchy rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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 : 01-OCT-2024 Patient stated that he and his wife received a Boostrix booster date on 19-AUG-2024 and on 20-AUG-2024 they started experiencing an itchy rash all over in torso, arms and legs that was not going away.  Patient received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago, but they did not had specific dates, brands, lot number or expiration dates for those doses.  Reporter were concerned that maybe there was too much of an ingredient in the particular lot number, potential product quality complaint administered to them and they doubt they were the only ones experiencing these symptoms. Another linked case for the wife is US202412110.; Sender's Comments:  US-GSK-US2024121100:Wife report
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: itchy rash all over in torso, arms and legs that is not going away; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27Y) for prophylaxis.   Previously administered products included tetanus, diphtheria, pertussis vaccine (Patient received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago.).   On 19-AUG-2024, the patient received Boostrix. On 20-AUG-2024, 1 days after receiving Boostrix, the patient experienced itchy rash (Verbatim: itchy rash all over in torso, arms and legs that is not going away). The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the itchy rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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 : 01-OCT-2024 Patient stated that he and his wife received a Boostrix booster date on 19-AUG-2024 and on 20-AUG-2024 they started experiencing an itchy rash all over in torso, arms and legs that was not going away.  Patient received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago, but they did not had specific dates, brands, lot number or expiration dates for those doses.  Reporter were concerned that maybe there was too much of an ingredient in the particular lot number, potential product quality complaint administered to them and they doubt they were the only ones experiencing these symptoms. Another linked case for the wife is US202412110.; Sender's Comments:  US-GSK-US2024121100:Wife report
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash all over in torso, arms and legs that is not going away; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27Y) for prophylaxis.   Previously administered products included tetanus, diphtheria, pertussis vaccine (Patient received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago.).   On 19-AUG-2024, the patient received Boostrix. On 20-AUG-2024, 1 days after receiving Boostrix, the patient experienced itchy rash (Verbatim: itchy rash all over in torso, arms and legs that is not going away). The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the itchy rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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 : 01-OCT-2024 Patient stated that he and his wife received a Boostrix booster date on 19-AUG-2024 and on 20-AUG-2024 they started experiencing an itchy rash all over in torso, arms and legs that was not going away.  Patient received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago, but they did not had specific dates, brands, lot number or expiration dates for those doses.  Reporter were concerned that maybe there was too much of an ingredient in the particular lot number, potential product quality complaint administered to them and they doubt they were the only ones experiencing these symptoms. Another linked case for the wife is US202412110.; Sender's Comments:  US-GSK-US2024121100:Wife report
Age: 89.0
Sex: M
Vaccine: FLU4, COVID19, FLU3
Symptoms: Arthralgia, Injection site pain, Insomnia
Clinical narrative: Shoulder Injury Resulting from Vaccine Administration. Pain and stiffness lasting over one month. Especially troubling at night, making it hard to sleep.
Age: 89.0
Sex: M
Vaccine: FLU4, COVID19, FLU3
Symptoms: Arthralgia, Musculoskeletal stiffness, Shoulder injury related to vaccine administration, Sleep disorder
Clinical narrative: Shoulder Injury Resulting from Vaccine Administration. Pain and stiffness lasting over one month. Especially troubling at night, making it hard to sleep.
Age: 42.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Immunisation reaction, Injection site erythema, Injection site swelling, Malaise, Mobility decreased
Clinical narrative: RED, SWOLLEN AREA WARM TO THE TOUCH AROUND THE INJECTION SITE
Age: 42.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RED, SWOLLEN AREA WARM TO THE TOUCH AROUND THE INJECTION SITE
Age: 77.0
Sex: M
Vaccine: UNK, FLU3
Symptoms: Transient ischaemic attack
Clinical narrative: Staff from Employee health reported adverse event to inpatient pharmacist at hospital (this reporter) on 10/15/24:On 10/8/24 at 13:15, pt received HD fluzone vaccine at employee health at hospital. On morning of 10/11/24 pt presented to emergency room at hospital for an acute episode of expressive aphasia at ~11AM which has since resolved. Pt reported inability to form sentences. On arrival to ED attending MD reports NIH stroke scale of 0. Pt evaluated by neurology who agreed in assessment of ED attending of not administering tPA, but did recommend admission to hospital for MRI as well as plavix given concern for high risk TIA. Patient was strongly against being admitted and signed out against medical advice with prescription for plavix after loading dose given here and recommendation to follow up with PCP or to return to ED if any more symptoms. Patient appeared fully recovered when leaving ED (although complete workup was not finished).
Age: 77.0
Sex: M
Vaccine: UNK, FLU3
Symptoms: Aphasia, Treatment noncompliance
Clinical narrative: Staff from Employee health reported adverse event to inpatient pharmacist at hospital (this reporter) on 10/15/24:On 10/8/24 at 13:15, pt received HD fluzone vaccine at employee health at hospital. On morning of 10/11/24 pt presented to emergency room at hospital for an acute episode of expressive aphasia at ~11AM which has since resolved. Pt reported inability to form sentences. On arrival to ED attending MD reports NIH stroke scale of 0. Pt evaluated by neurology who agreed in assessment of ED attending of not administering tPA, but did recommend admission to hospital for MRI as well as plavix given concern for high risk TIA. Patient was strongly against being admitted and signed out against medical advice with prescription for plavix after loading dose given here and recommendation to follow up with PCP or to return to ED if any more symptoms. Patient appeared fully recovered when leaving ED (although complete workup was not finished).
Age: 8.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given the adult dose of the twinrix vaccine at her 8 year well child check. The state was contacted and gave guidance on the situation, they advised the doses are still valid and she should get the age appropriate does at the next scheduled interval, which in this case is Hep A in 6 months. Patients parents were contacted and informed of what side effects to look out for per state guidelines. They understood this information and had no further questions or concerns.
Age: 8.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Incorrect dose administered
Clinical narrative: Patient was inadvertently given the adult dose of the twinrix vaccine at her 8 year well child check. The state was contacted and gave guidance on the situation, they advised the doses are still valid and she should get the age appropriate does at the next scheduled interval, which in this case is Hep A in 6 months. Patients parents were contacted and informed of what side effects to look out for per state guidelines. They understood this information and had no further questions or concerns.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Neoplasm malignant
Clinical narrative: the increase in myocarditis and turbo cancer; the increase in myocarditis and turbo cancer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 51-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), NEOPLASM MALIGNANT (medically significant), outcome "unknown" and all described as "the increase in myocarditis and turbo cancer".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Injection site pain, Injection site warmth, Myalgia, Oropharyngeal pain
Clinical narrative: 10-11-2024: Whole body ache. Muscles aching. Left arm site injection painful, warm to touch. Took 2 caplets of acetaminophen around 5:45/6 pm. Went to bed around 7:30 pm. Woke up around 1130pm with whole body ache and chills. Took 2 caplets of acetaminophen around 1230 am. Woke up around 6:15 am, still achy, took 2 caplets of acetaminophen around 7am. Body still achy, took 2 more caplets of acetaminophen around 6:30/7:00pm, went to bed around 8:30 pm.  10-12-2024: feeling 95% better. Sore throat on the left side.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain, Sleep disorder
Clinical narrative: 10-11-2024: Whole body ache. Muscles aching. Left arm site injection painful, warm to touch. Took 2 caplets of acetaminophen around 5:45/6 pm. Went to bed around 7:30 pm. Woke up around 1130pm with whole body ache and chills. Took 2 caplets of acetaminophen around 1230 am. Woke up around 6:15 am, still achy, took 2 caplets of acetaminophen around 7am. Body still achy, took 2 more caplets of acetaminophen around 6:30/7:00pm, went to bed around 8:30 pm.  10-12-2024: feeling 95% better. Sore throat on the left side.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: HCP called to report that an infant that was administered ROTATEQ 9/27/2024, vomited a few minutes later.; This spontaneous report was received from pharmacist and refers to an infant patient of an unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-SEP-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (strength, lot #, expiry date, vaccination scheme, route of administration and indication were not provided).  On the same day, a few minutes later, the patient vomited. At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.   Lot # is being requested and will be submitted if received.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: "we had given a Kinrix to a child that is not within that 4-6 age range...we've had the same incident."; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 10-SEP-2024, the patient received Kinrix. On 10-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: "we had given a Kinrix to a child that is not within that 4-6 age range...we've had the same incident."). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 04-OCT-2024 The nurse reported that on 10th September 2024, we had given a Kinrix vaccine to a child that is not within that 4 to 6 age range which led to inappropriate age at vaccine administration. The nurse reported that we had the same incident. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Impaired quality of life
Clinical narrative: RUINED LIFE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1 ) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers . No concomitant medications were reported. On an unspecified date, the patient experienced ruined life (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ruined life was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This solicited report received from a health care professional concerned multiple patients of unspecified age and sex. The patient was enrolled in a non-company sponsored study COV19VAC-NONCOMP: Jansen COVID 19 Non Company Solicited Study. These patients were also referenced in literature. In a longitudinal, retrospective, observational cohort, multicenter study of 433 patients was conducted between April 2021 and November 2022, a patient [age and sex not stated] was described, who developed myocarditis folowing Ad26.COV2-S [Johnson & Johnson vaccine] vaccination [route, dosage, duration of treatment to reaction onset and outcome not stated]. The trade name of covid-19 vaccine ad26.cov2.s was not reported. It was assumed to be Janssen drug for reporting purposes. The patients weight, height, and medical history were not reported. The patients were vaccinated with covid-19 vaccine ad26.cov2.s (dose in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the patients experienced myocarditis  (dose in series 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and myocarditis as related. Company causality between covid-19 vaccine ad26.cov2.s, and myocarditis was not related.  Author Comment" "We included patients with a clinical diagnosis of acute myocarditis after COVID-19 vaccination [Ad26.COV2-S vaccine]". This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Myocarditis: The event is labelled per RA, hence assessed as potentially related
Age: 7.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions - patient given at 7 yrs 1 month of age. Guidelines state immunization valid for 4-6 yr old. Mother notified. Information sent to VAERS.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Body temperature increased, Chills, Malaise, Vomiting
Clinical narrative: chills (2 hours) temperature 103.9 vomiting sick for a week went to E.R.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Cardiac monitoring abnormal, Cerebral haemorrhage, Coronary arterial stent insertion
Clinical narrative: Sudden Atrial Fibrillation. Never symptoms. Previous normal heart. AFib discovered by wearing ZioXT Heart Monitor after fall requiring hospitalization. He wore heart monitor 2/25/22 to 3/11/22 for 13 days. AFib noted only 3/7/22 to 3/11/22. First time. In AFib 31% of time. Started on Eliquis blood thinner. smart watch shows in AFib often now, but no symptoms. A electrophysiologist he saw later did not treat the AFib. Later in 2022 diagnosed with Normal Pressure Hydrocephalus. More cardiac problems requiring stints during pre-surgery clearancee. Brain bleed on 1/18/23 after VP Shunt Brain Surgery 1/11/23. Maybe brain bleed related to abnormal clotting seen with COVID-19 shots?
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Normal pressure hydrocephalus, Ventriculo-peritoneal shunt
Clinical narrative: Sudden Atrial Fibrillation. Never symptoms. Previous normal heart. AFib discovered by wearing ZioXT Heart Monitor after fall requiring hospitalization. He wore heart monitor 2/25/22 to 3/11/22 for 13 days. AFib noted only 3/7/22 to 3/11/22. First time. In AFib 31% of time. Started on Eliquis blood thinner. smart watch shows in AFib often now, but no symptoms. A electrophysiologist he saw later did not treat the AFib. Later in 2022 diagnosed with Normal Pressure Hydrocephalus. More cardiac problems requiring stints during pre-surgery clearancee. Brain bleed on 1/18/23 after VP Shunt Brain Surgery 1/11/23. Maybe brain bleed related to abnormal clotting seen with COVID-19 shots?
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Dizziness, Dyspnoea, Headache
Clinical narrative: Left arm injection feeling slight headache went home. Felt more light headed. Needed asthma inhaler. Sat down to relax and took a breathing treatment but did not stop the tightening of breath. Rash formed on left arm near wrist. Went to E.R. two hours later shaking bad. Benadryl I.V. given, shaking stopped. Breathing worsened. Admitted on 3rd day Pneumonia found!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Rash, Tremor
Clinical narrative: Left arm injection feeling slight headache went home. Felt more light headed. Needed asthma inhaler. Sat down to relax and took a breathing treatment but did not stop the tightening of breath. Rash formed on left arm near wrist. Went to E.R. two hours later shaking bad. Benadryl I.V. given, shaking stopped. Breathing worsened. Admitted on 3rd day Pneumonia found!
Age: 0.5
Sex: F
Vaccine: DTAPIPV, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: When prepping the vaccinations, I accidentally grabbed the improper pre-filled syringe, and administered the immunization to patient on her right thigh. She was supposed to receive the combo vaccination 'Vaxelis' that has Dtap-IPV-Hib-HepB, instead she received the Dtap-IPV immunization intended for 4 year olds.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Drastic increase in tinnitus
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: searing pain at time of injection then 5 hours later was unable to move arm
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Flatulence, Nausea, Oropharyngeal pain
Clinical narrative: The fever and chills and sore throat started at 7:30pm. The diararhea and gas started around 9pm. Adverse effects: Fever, chills, sore throat, diarrhea, severe nausea, severe GI gas.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: The fever and chills and sore throat started at 7:30pm. The diararhea and gas started around 9pm. Adverse effects: Fever, chills, sore throat, diarrhea, severe nausea, severe GI gas.
Age: 75.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Patient called concerned about symptoms  of feeling dizzy and being lightheaded around 8:30pm in the evening on 10/14/2025. They did not feel like they were going to faint . Followed up with patient on 10/15/2024 8:30am , patient reports of feeling better just a little headache and sore arm but symptoms are improving .
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site pain, Injection site pruritus, Skin swelling, Skin warm
Clinical narrative: PCV 20 vaccine given in R deltoid 10/3/24 (Thursday) soreness same day. Per patient Monday afternoon (10/7/24) site began itching along with the soreness continued. Tuesday AM, woke to pink skin and swelling. Woke up 10/10/24 to worsening swelling, hot to touch and painful. Cephalexin given and Solumedrol injection given.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Dizziness, Injection site pain, Palpitations
Clinical narrative: pt states within less than minute after being vaccinated, he became dizzy while standing. He sat down for about 20 minutes. The dizziness lasted about an 1 1/2 hours. His heart was racing and he felt like he was going into defib. (He had taken his heart medication before getting the vaccine.) After the dizziness he became very weak so he laid down for about an hour. When he got back up the dizziness was better, his heart rate and heart fluttering was better but he was still weak. Today he has a sore arm around the injection site and still feels weak but is feeliing some better. There was no fever,  muscle pain or joint pain. He has an appt with his doctor next week and will follow up with him.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC20
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood chloride normal, Differential white blood cell count normal, Faeces discoloured
Clinical narrative: 1d after vaccines developed pale grey stools, increased fussiness.   2d after vaccine increased fussiness and had 3 more pale grey stools which seemed painful to pass.  3d after vaccine: no void x 15hrs, refusing bottle, vomited x 1, 6 pale grey stools which seemed painful.  Was evaluated at local Hospital ER.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC20
Symptoms: Hypophagia, Irritability, Metabolic function test normal, Vomiting
Clinical narrative: 1d after vaccines developed pale grey stools, increased fussiness.   2d after vaccine increased fussiness and had 3 more pale grey stools which seemed painful to pass.  3d after vaccine: no void x 15hrs, refusing bottle, vomited x 1, 6 pale grey stools which seemed painful.  Was evaluated at local Hospital ER.
Age: 52.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Electrocardiogram ambulatory, Ventricular extrasystoles
Clinical narrative: Started having PVCs and ongoing.  I had it before but seems to be persistent that my watch is saying inconclusive for afib.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Brain scan normal, Burning sensation, Cardiac monitoring normal, Chills, Dizziness
Clinical narrative: Severe nerve pain, numbness, itching, burning in left thigh. Severe lightheadedness, nausea, lost consciousness. Woke up with body aches and chills.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear tube insertion, Echocardiogram, Electrocardiogram normal, Head discomfort, Hypoaesthesia
Clinical narrative: Severe nerve pain, numbness, itching, burning in left thigh. Severe lightheadedness, nausea, lost consciousness. Woke up with body aches and chills.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Nerve stimulation test normal, Neuralgia, Pain
Clinical narrative: Severe nerve pain, numbness, itching, burning in left thigh. Severe lightheadedness, nausea, lost consciousness. Woke up with body aches and chills.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe nerve pain, numbness, itching, burning in left thigh. Severe lightheadedness, nausea, lost consciousness. Woke up with body aches and chills.
Age: 8.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Extra dose administered
Clinical narrative: Did not have vaccine records on file in patients chart, nothing available in Query when RN ran it, provider ordered (HepA, HepB, Proquad, IPol and Tdap) vaccines based on information we had available in chart. Parent who was not present at time of visit called office to inform patient had been previously vaccinated and we did not have complete records at time of immunization, provider who ordered vaccines called parent to discuss this.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received 2 flu shots in the same arm on the same day
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Cough, Diarrhoea, Dysphagia
Clinical narrative: Post vaccination on 10/4/24 this patient reports that she felt pain travel from her right arm down to her right thigh immediately following vaccination. She reports that in the afternoon on 10/4 following vaccination she developed nasal congestion and a cough. Around 5pm on 10/4 patient reports that she had trouble swallowing and difficulty breathing. The patient went to a local emergency room at hospital. At the hospital she had hypertensive urgency (Systolic 170) despite taking her anti-hypertensive medication ramipril, which the patient reports controls her blood pressure in the 130s-140s. No other ER interventions were reported. The patient was discharged home from the ER in the evening on 10/4/24.  The patient reports that overnight 10/4-10/5 she experienced headache, weakness, nausea, and diarrhea. In the morning on 10/5 the patient reports feeling a bit better, but the headache and high blood pressure persisted on 10/5 and continued into 10/6. On 10/6 the patient also developed blurry vision, left leg pain, and a left thigh rash. On 10/7 the patient presented to her primary care provider and was referred to the emergency department at another  hospital where thrombosis was ruled out and patient was discharged.  The patient reported the information above to the vaccinating facility, Department of Health, on 10/9/24. At the time of reporting, patient sates that her status is improving and her blood pressure remains elevated despite taking ramipril. As of 10/15/24 patient is fully recovered.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Hypertensive urgency, Immediate post-injection reaction, Nasal congestion
Clinical narrative: Post vaccination on 10/4/24 this patient reports that she felt pain travel from her right arm down to her right thigh immediately following vaccination. She reports that in the afternoon on 10/4 following vaccination she developed nasal congestion and a cough. Around 5pm on 10/4 patient reports that she had trouble swallowing and difficulty breathing. The patient went to a local emergency room at hospital. At the hospital she had hypertensive urgency (Systolic 170) despite taking her anti-hypertensive medication ramipril, which the patient reports controls her blood pressure in the 130s-140s. No other ER interventions were reported. The patient was discharged home from the ER in the evening on 10/4/24.  The patient reports that overnight 10/4-10/5 she experienced headache, weakness, nausea, and diarrhea. In the morning on 10/5 the patient reports feeling a bit better, but the headache and high blood pressure persisted on 10/5 and continued into 10/6. On 10/6 the patient also developed blurry vision, left leg pain, and a left thigh rash. On 10/7 the patient presented to her primary care provider and was referred to the emergency department at another  hospital where thrombosis was ruled out and patient was discharged.  The patient reported the information above to the vaccinating facility, Department of Health, on 10/9/24. At the time of reporting, patient sates that her status is improving and her blood pressure remains elevated despite taking ramipril. As of 10/15/24 patient is fully recovered.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity, Rash, Ultrasound Doppler normal, Vision blurred
Clinical narrative: Post vaccination on 10/4/24 this patient reports that she felt pain travel from her right arm down to her right thigh immediately following vaccination. She reports that in the afternoon on 10/4 following vaccination she developed nasal congestion and a cough. Around 5pm on 10/4 patient reports that she had trouble swallowing and difficulty breathing. The patient went to a local emergency room at hospital. At the hospital she had hypertensive urgency (Systolic 170) despite taking her anti-hypertensive medication ramipril, which the patient reports controls her blood pressure in the 130s-140s. No other ER interventions were reported. The patient was discharged home from the ER in the evening on 10/4/24.  The patient reports that overnight 10/4-10/5 she experienced headache, weakness, nausea, and diarrhea. In the morning on 10/5 the patient reports feeling a bit better, but the headache and high blood pressure persisted on 10/5 and continued into 10/6. On 10/6 the patient also developed blurry vision, left leg pain, and a left thigh rash. On 10/7 the patient presented to her primary care provider and was referred to the emergency department at another  hospital where thrombosis was ruled out and patient was discharged.  The patient reported the information above to the vaccinating facility, Department of Health, on 10/9/24. At the time of reporting, patient sates that her status is improving and her blood pressure remains elevated despite taking ramipril. As of 10/15/24 patient is fully recovered.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Immediately after shot patient felt "woozy". Patient confirmed dizziness and light headedness. Patient sat at the pharmacy for 30 minutes was provided water and ice pack while being monitored. Followed up with patient evening of vaccination and following morning. Patient still feels "woozy" but functional. Patient stated this was an "atypical" reaction for him.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There was no adverse reaction. Afluria for ages 3years and over was given to this patient. The patient was 2years and 8 months old. The mother was notified of this error and the child has been monitored and no reaction noted. Mother denied patient having any type of reaction to this vaccine. The manufacturer has been called and they have reported this event as well.
Age: 16.0
Sex: M
Vaccine: MNP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: More severe reaction site pain and swelling
Age: 64.0
Sex: F
Vaccine: COVID19, HEP, MMR, TDAP
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse reaction noted, administered Moderna Spikevax 2023-2024 vaccine as per RE asked us to utilize until expiration date 9/29/2024. Had received email, August 22, 2024, to discontinue use of Spikevax 2023-2024. I contacted RE for guidance to remove from inventory and she mentioned it only applied to TVFC (children vaccine) not the Adult Spikevax to continue to utilize until expiration date. Administered Spikevax to this client, no adverse reaction noted but was told a VAERS report needed to be filled out. We were told in September to no longer use it.