chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Reactive Arthritis" (unspecified if ongoing); "Bee stings" (unspecified if ongoing); "Coconut" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bupropion, reaction(s): "Allergy: Bupropion". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "chills", "fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "chills", "fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "chills", "fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "chills", "fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown". Additional information: Have received Pfizer vaccine since start of Covid. Have gotten flu and Covid shot at the same time since Covid began. Other than fever and chills, have not had any other side effects until now.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400261257 same patient, different doses;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Upper lip started swelling 24 hours after the injection and kept swelling for another couple hours/Stayed swelled for about 15/18 hours; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Sep2024 at 18:00 as dose 1, single (Lot number: LM2222) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious) with onset 19Sep2024 at 18:00, outcome "not recovered", described as "Upper lip started swelling 24 hours after the injection and kept swelling for another couple hours/Stayed swelled for about 15/18 hours". Therapeutic measures were not taken as a result of lip swelling.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from a consumer from medical information team, Program ID.  A male patient received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: MALAISE (non-serious) with onset 2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Not feeling well".  Additional Information: The patient mentioned having side effects, symptoms next day after Pfizer COVID-19 vaccination that he has received in Oct2023. Per patient, he did not remember the actual side effects but next day he was put out of commission, as far as the things that he needed to do just was not feeling well. The patient was asking for the name of the current Pfizer COVID-19 Vaccine if there is an additional part of the name of the newest version of Pfizer COVID-19 vaccine.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: fever; Muscle weakness and tenderness; Muscle weakness and tenderness; Chest pains; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 20Sep2024, this case now contains all required information to be considered valid.  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: PYREXIA (non-serious), outcome "unknown", described as "fever"; MUSCULAR WEAKNESS (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "Muscle weakness and tenderness"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pains".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Generalised oedema, Pain
Clinical narrative: severe allergic reactions; cause her body to be "stingy and swollen" and that you even feel it on your feet; cause her body to be "stingy and swollen" and that you even feel it on your feet; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00274.  A 72-year-old female 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 included: "Severe allergies to painkillers and OTC" (unspecified if ongoing), notes: severe allergies to other medications such as painkillers and over-the-counter drugs; "severe allergies to a lot of vaccines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Dose number unknown, every time she has a severe reaction, she ends up in the hospital), for Covid-19 immunization, reaction(s): "Severe allergy"; Johnson and johnson covid-19 vaccine (Dose number unknown), for Covid-19 immunization. The following information was reported: ALLERGY TO VACCINE (hospitalization), outcome "unknown", described as "severe allergic reactions"; GENERALISED OEDEMA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "cause her body to be "stingy and swollen" and that you even feel it on your feet". Patient reported that every time she has a severe reaction, she ends up in the hospital and it is "pure agony". Patient also stated that these severe allergic reactions cause her body to be "stingy and swollen" and that you even feel it on your feet. Patient would like a list of the ingredients used in the Novavax COVID-19 vaccine. She has severe allergies and has already had a severe allergic reaction to the Moderna and Pfizer COVID-19 vaccine, so she is doing some research to see if there could be a potential issue if she got the Novavax COVID-19 vaccine this time.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal
Clinical narrative: feels bad; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774018 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that the first 2 vaccines that had are from Pfizer but was notable to verify. The reporter also shared that was feeling bad as well.    No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400260197 same patient/reporter/AE, different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he had COVID; he had COVID; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRIVALENT INFLUENZA VACCINE, in Sep2024 as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Sep2024, outcome "not recovered" and all described as "he had COVID". Clinical course: The patient had taken Pfizer's COVID shots right from the beginning and had the latest COVID shot about two weeks ago. The patient also had the three in one flu shot.  The patient found out in the morning of 20Sep2024 that he had COVID and was prescribed molnupiravir (LAGEVRIO). The patient tried to purchase molnupiravir but was instructed by the pharmacist to call Pfizer before they could dispense the drug.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I started getting bumps to the upper half of my body, they itch; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 59-year-old male patient received BNT162b2 (BNT162B2), in Jul2022 as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (2nd dose, manufacturer unknown), for covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset Oct2022, outcome "unknown", described as "I started getting bumps to the upper half of my body, they itch". Additional information: The patient has been to three different dermatologists and he has received absolutely no relief. He is convinced the ONLY thing that could be the source of these mysterious bumps resembling insect bites is the covid shot. These bumps come and goes and they itch especially when he sweats.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Headache, Nausea, Pain
Clinical narrative: I have had a severe headache since the day after the vaccine. I've had nausea and diarrhea. I'm on day seven of these symptoms.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction noted or reported. Extra dose administered
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: Patient stated that she had nausea and her arm was numb for 4 days after getting the vaccine.  She stated that after the four day, every thing was fine. She was no longer nauseate and her arm was fine.
Age: 60.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was administered to this 60 year old patient by mistake. I gave him the PQCF form without dropping the immunizations, because we were busy at the time, intending to drop the vaccines later. Multiple patients were getting similar vaccines at that time as well. A technician was trying to help and actually administered the vaccines before they were dropped in input, while other people were also waiting in the lobby area. Wires got crossed, and pharmacist provided the technician with the wrong flu shot, Fluzone HD vaccine, instead of the regular dose Fluzone or Flublok. The mistake was discovered when attempting to scan in the vaccines in the handheld, but the shots were not yet in the handheld to scan. I attempted to call to inform the patient but no answer and voicemail box was full. Called to inform PCP Dr and spoke with after hours representative who will leave a detailed message for them to call if they have any further questions.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Starting the night of 9/20/24 pt experience pain and redness at injection site and later a red rash approximately 12 inches by 6 inches over arm
Age: 75.0
Sex: M
Vaccine: COVID19, HEPAB, PNC20
Symptoms: Dizziness, Hypotension
Clinical narrative: Dizziness after receiving vaccines, low BP.  patient sat while we monitored bp took ~30 minutes for symptoms to improve
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3, PNC13
Symptoms: Chills, Gait disturbance, Nausea, Pain, Pyrexia
Clinical narrative: chills,shaking, fever,nausea,extreme pain all over  body with every movement, unstable when attempting to walk,symptoms lasted 24 hours.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3, PNC13
Symptoms: Tremor
Clinical narrative: chills,shaking, fever,nausea,extreme pain all over  body with every movement, unstable when attempting to walk,symptoms lasted 24 hours.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: A flu vaccine was ordered for this patient. the medical assistant inadvertently administered a Tdap instead.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: The patient fainted approximately 10 minutes after receiving vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: HIVES APPEARING 48 HOURS AFTER VACCINATION THAT RESOLVED ON THEIR OWN WITHOUT TREATMENT
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Haematochezia, Occult blood negative, Rash, Rash pruritic, Rotavirus test positive
Clinical narrative: Patient developed a whole itchy body rash within a few hours of vaccination. Patient developed blood streaks in her stool on 9/14 and 9/15. Blood streaks resolved by 9/16. Stool sample was ordered for testing on 9/16. Sample was not brought to lab until 9/24, at which time it tested positive for rotavirus. Patient continues with rash as of 9/24//24.
Age: 75.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: fever (did not confirm, but states knows when has fever), nausea, joint pain, numbness, SOA, difficulty sleeping, fatigue, decrease appetite, band of pain across abdomen
Age: 75.0
Sex: M
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Insomnia, Nausea, Pyrexia
Clinical narrative: fever (did not confirm, but states knows when has fever), nausea, joint pain, numbness, SOA, difficulty sleeping, fatigue, decrease appetite, band of pain across abdomen
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The adverse event was administering a 3rd dose of shingles vaccine to a patient who had already received the necessary 2 doses.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness
Clinical narrative: patient passed out after 2nd shot.  911 was called. pt recovered in about 15-30 seconds.  paramedics arrived and pt was released.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle twitching, Muscular weakness, Pain in extremity, Tremor
Clinical narrative: Patient is a 47 year old patient who reports  states had flu vaccine 9/3/24 right arm within 12 hours had intense twitching in arm x 10 days and pain at the injection site still pain muscle weakness and shakiness in the same arm   is able to grasp objects, but can have trembling/shaking with holding the object
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient did not tell us she previously got Arexvy but we found out after we already gave the vaccine insurance paid for Arexvy last year and Abrysvo this time so we didn't see until after
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Oropharyngeal pain, Pain in extremity
Clinical narrative: Pain in left and right arm and shoulders, overall fatigue that has lasted 24 hrs and continues; temp of 99.1, sore throat.  Plus despite being vaccinated and boosted, I contracted Covid in Nov of 2023 (lasted 10 miserable days);  then AGAIN in May 2024 (lasted 6 days)
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came back to pharmacy to report and show that  her left arm was red and warm to the touch with some swelling.  She wanted  to receive both shots in the left due to  some issues with her right arm.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site pain, Mobility decreased, Pain, Sensory disturbance
Clinical narrative: Patient came to the Employee Flu Clinic to receive her flu shot at 8:48am. She reported history of anxiety, fainting, and dizziness with vaccinations. Patient stated she had eaten breakfast and drank water before arriving. She had also taken her anxiety medication this morning and had mentally prepared herself for the injection. Patient consented to injection. Injection given to left deltoid with no complications. Patient states she felt well and left at 08:53am. Patient returned around 09:40am stating she could not move her arm, had extreme pain, and felt a fluttery feeling throughout her body. Patient given water, ice pack for arm, vitals taken, and physical assessment. BP 130/70 HR 80 Temp 98.1 f SPO2 99%. Alert and oriented x4, PERLA, skin pink warm and dry. Full range of motion and sensation in all 4 extremities. lungs clear throughout. Band aid had been removed from left deltoid was tender to touch and free from edema redness bruising or bleeding. Pain 7/10 in left deltoid described as discomfort, onset 7 minutes after injection. Radial pulse +2 bilaterally. Patient stated it felt like an anxiety attack but not quite. She takes Atarax for anxiety attacks but it makes her tired so she does not want to take it now. Her fluttery feeling feels also like dizziness but not quite. Is most comfortable sitting. States she has a difficult relationship with food and does not want to eat because it might make her vomit. States she took Zofran SL and Prozac PO this morning around 5am. Has NKDA. Patient monitored until 10:00am with minimal improvement, still feeling fluttering throughout her body and 6/10 pain in her left deltoid. Rapid repose was called. Providers arrived at 10:05am. Assessed, given Tylenol 600mg PO, transported via wheelchair to exam room for monitoring.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received the RSV vaccine from his doctor in July. He came to pharmacy and received a second vaccine 9/24/24
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Throat irritation, Urticaria
Clinical narrative: Rash and swelling of face. Rash and hives on arms. Itchy throat.  Urgent care visited. Steroids prescribed and shot given during visit. Benadryl cream to help with itchy rash and hives. Told to continue taking Benadryl  to maintain allergic reaction symptoms. Epi pen prescribed for emergency use as a precaution.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, aches, fatigue
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: No adverse event
Clinical narrative: No symptoms or signs of adverse reaction  on administration date 9/17 /2024. Patients mother  was advised to wait with pt 15min for observation.  No symptoms, or signs of adverse reaction noted on 9/19/2024 during Provider visit
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given second fluad shot. previously received 2024-2025 fluad series on 08/23. Patient did not experience any side effects or symptoms, said she felt fine and not acutely ill.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Vaccination error
Clinical narrative: Patient received a 2nd dose of RSV (Arexvy) when only one dose is currently indicated (1st dose was 10/2023).  Therefore this dose on 09/20/24 was outside of recommendations.  This is reporting of vaccine error not actual adverse event.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tremor
Clinical narrative: Patient called pharmacy to inform pharmacist that she was having the following symptoms: shaking without  fever and nausea. She denies taking any other medications after the vaccines only eating at fast food restaurant. She will treat her symptoms with otc medications, monitor and keep us informed.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Dizziness, Dyskinesia, Electrocardiogram, Full blood count
Clinical narrative: AFTER PT CAME HOME AFTER VACCINE ADM. VISIT SHE BECAME  LIGHTHEADED & PASSED OUT WHILE STANDING & THEN HAD JERKY MOVEMENTS OF EXTREMITIES FOR 5-6 SECONDS. NO INCONTINANCE, NO BITING OF TONGUE. AT THAT POINT PT WAS TAKEN TO ER FOR EVALUATION.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Metabolic function test, Urine analysis
Clinical narrative: AFTER PT CAME HOME AFTER VACCINE ADM. VISIT SHE BECAME  LIGHTHEADED & PASSED OUT WHILE STANDING & THEN HAD JERKY MOVEMENTS OF EXTREMITIES FOR 5-6 SECONDS. NO INCONTINANCE, NO BITING OF TONGUE. AT THAT POINT PT WAS TAKEN TO ER FOR EVALUATION.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swollen, hard, red and itchy injection site. General flu like symptoms for 2 days.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PATIENT CALLED AROUND 6:00PM TO LET THE PHARMACIST KNOW THAT HER ARM WAS VERY SORE. SHE WAS CONCERNED THAT THE VACCINATION, GIVEN BY THE VACCINATING PHARMACY TECHNICIAN  WAS GIVEN TOO HIGH BECAUSE OF THE PAIN IN HER ARM. PHARMACIST ADVISED HER TO TAKE IBUPROFEN AND USE AN ICE PACK AND SEE HOW IT WAS DOING IN THE MORNING. PHARMACIST REVIEWED TECHNIQUE WITH TECHNICIAN. TECHNICIAN STATED THAT SHE HAD A VERY BONEY ARM AND HE USED THE "C" METHOD FROM THE TOP OF HER SHOULDER. PHARMACY MANAGER ATTEMPTED CONTACT 9/9/24, BUT DID NOT REACH PATIENT. PATIENT CALLED BACK THE WEEK LATER 9/16/24 AND SPOKE WITH PHARMACY MANAGER. SHE MENTIONED SHE WAS FEELING MUCH BETTER, BUT IT WAS SORE FOR A FEW DAYS. THE PHARMACY MANAGER THANKED HER FOR HAVING THE COURAGE TO SPEAK UP AND LET HER KNOW THAT THE PHARMACISTS WOULD REVIEW TECHNIQUE WITH THE TECHNICIAN, HAVE HIM WATCH BOTH PHARMACISTS TECHNIQUE, AND THEN WE WOULD OBSERVE AN INJECTION PRIOR TO IMMUNIZING AGAIN. THE PATIENT SEEMED SATISFIED WITH THAT.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Chills for approximately 12 hours, low grade fever for approximately 24 hours, redness and swelling at injection site, sore and tender arm
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Chills for approximately 12 hours, low grade fever for approximately 24 hours, redness and swelling at injection site, sore and tender arm
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Very large area of swelling and redness. Entire deltoid and upper arm is swollen, circumference is 5cm larger than the other arm. Very painful and bright red. Hot to touch.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP, FLU3, HPV9, MNQ, TDAP
Symptoms: Pallor, Presyncope
Clinical narrative: Patient complained of pain in his left arm right after vaccine at 5:15. He went to bathroom and mom went with him. Mom called from bathroom at 5:17 to say something was wrong. His head was on the toilet, he was very pale and not responding to our questions. We layed him on the floor, elevated his legs and he started mumbling. Pox 95-98%, HR 70s. He said his head and arm hurt. BP 120/70. Kept him with legs elevated for about 10-15 minutes. He sat up and felt a little better. We had him drink some water, but still dizzy. Had him lay down for 10 more minutes. Then sat him up, had him drink more water, talking more and feeling better. Observed for 30 minutes total after vaccine before he went home with mom.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP, FLU3, HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Pain in extremity, Pallor
Clinical narrative: Patient complained of pain in his left arm right after vaccine at 5:15. He went to bathroom and mom went with him. Mom called from bathroom at 5:17 to say something was wrong. His head was on the toilet, he was very pale and not responding to our questions. We layed him on the floor, elevated his legs and he started mumbling. Pox 95-98%, HR 70s. He said his head and arm hurt. BP 120/70. Kept him with legs elevated for about 10-15 minutes. He sat up and felt a little better. We had him drink some water, but still dizzy. Had him lay down for 10 more minutes. Then sat him up, had him drink more water, talking more and feeling better. Observed for 30 minutes total after vaccine before he went home with mom.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP, FLU3, HPV9, MNQ, TDAP
Symptoms: Speech disorder, Unresponsive to stimuli
Clinical narrative: Patient complained of pain in his left arm right after vaccine at 5:15. He went to bathroom and mom went with him. Mom called from bathroom at 5:17 to say something was wrong. His head was on the toilet, he was very pale and not responding to our questions. We layed him on the floor, elevated his legs and he started mumbling. Pox 95-98%, HR 70s. He said his head and arm hurt. BP 120/70. Kept him with legs elevated for about 10-15 minutes. He sat up and felt a little better. We had him drink some water, but still dizzy. Had him lay down for 10 more minutes. Then sat him up, had him drink more water, talking more and feeling better. Observed for 30 minutes total after vaccine before he went home with mom.
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Delirium, Nasal congestion, Nausea, Pyrexia
Clinical narrative: Per phone note on 9/25/24. "Called mom. Pt had flu shot on Saturday. Sunday was not feeling well, had fever 100. Stuffy nose, sore throat, nausea, vomiting x 1., coughing when awake. Given tylenol and diphenhydramine to help with sleep/sore throat. Yesterday she was opening eyes and seemed "awake but not awake", took time to focus. Not answering mom very well/dazed out of it. Peed x 2 and pooped yesterday. Peed overnight as well. Highest temp today 100, responding better to mom, no having the same dazed behavior as yesterday. No trouble breathing, family has home O2 monitor and oxygen level is fine, sore throat improving. Wants to know her flu vaccine number and for us to put in a VAERS."
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Per phone note on 9/25/24. "Called mom. Pt had flu shot on Saturday. Sunday was not feeling well, had fever 100. Stuffy nose, sore throat, nausea, vomiting x 1., coughing when awake. Given tylenol and diphenhydramine to help with sleep/sore throat. Yesterday she was opening eyes and seemed "awake but not awake", took time to focus. Not answering mom very well/dazed out of it. Peed x 2 and pooped yesterday. Peed overnight as well. Highest temp today 100, responding better to mom, no having the same dazed behavior as yesterday. No trouble breathing, family has home O2 monitor and oxygen level is fine, sore throat improving. Wants to know her flu vaccine number and for us to put in a VAERS."
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abnormal behaviour, Cough, Feeling abnormal, Hyporesponsive to stimuli, Malaise
Clinical narrative: Per phone note on 9/25/24. "Called mom. Pt had flu shot on Saturday. Sunday was not feeling well, had fever 100. Stuffy nose, sore throat, nausea, vomiting x 1., coughing when awake. Given tylenol and diphenhydramine to help with sleep/sore throat. Yesterday she was opening eyes and seemed "awake but not awake", took time to focus. Not answering mom very well/dazed out of it. Peed x 2 and pooped yesterday. Peed overnight as well. Highest temp today 100, responding better to mom, no having the same dazed behavior as yesterday. No trouble breathing, family has home O2 monitor and oxygen level is fine, sore throat improving. Wants to know her flu vaccine number and for us to put in a VAERS."
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nasal congestion, Nausea, Oropharyngeal pain, Sleep disorder, Vision blurred
Clinical narrative: Per phone note on 9/25/24. "Called mom. Pt had flu shot on Saturday. Sunday was not feeling well, had fever 100. Stuffy nose, sore throat, nausea, vomiting x 1., coughing when awake. Given tylenol and diphenhydramine to help with sleep/sore throat. Yesterday she was opening eyes and seemed "awake but not awake", took time to focus. Not answering mom very well/dazed out of it. Peed x 2 and pooped yesterday. Peed overnight as well. Highest temp today 100, responding better to mom, no having the same dazed behavior as yesterday. No trouble breathing, family has home O2 monitor and oxygen level is fine, sore throat improving. Wants to know her flu vaccine number and for us to put in a VAERS."
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No side effects were reported.; HCP calling to report a patient potentially received GARDASIL 9 instead of PREVNAR 20. HCP did not report this was due to any type of product confusion, just simple misuse. Filing AE out of precaution. No additional information/clarification provided; This spontaneous report has been received from an other health care professional concerning a 23-year-old male patient. The patient's concurrent conditions medical history, and concomitant medications were not reported.  On 06-AUG-2024, the patient was potentially vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number: 1965045, expiration date: 19-JAN-2026 (strength, exact dose, route of administration, and anatomical location were not provided) as prophylaxis instead of receiving pneumococcal vaccine conj 20v (crm197)(PREVNAR 20) (Interchange of vaccine products). The reporter did not report this was due to any type of product confusion. No additional information. No side effects were reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product name confusion, Wrong product administered
Clinical narrative: -II was inadvertently given PROQUAD on 9/20/2024 due to "similar names." Caller rep; Medical assistant calling to report that  a 12 month old patient who was scheduled to receive a dose of MMR-II was inadvertently given PROQUAD on 9/20/2024 due to "similar names."; MMR-II was inadvertently given PROQUAD on 9/20/2024 due to "similar names."; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown age.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  The patient was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided), was inadvertently given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human Albumin) (PROQUAD) injection, 0.5 mls intramuscularly, lot #Y008788, expiration date was reported and confirmed as 30-OCT-2025 (Wrong product administered), administered for prophylaxis (strength was not provided) on 20-SEP-2024 due to "similar names" (Product name confusion). Caller reported no symptoms. No further information was reported. Operator of device was a health professional. Confirmed no additional adverse event /product quality complaint.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse reported that a patient received a dose of VAQTA after its expiration date; This spontaneous report was received from a nurse regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not provided.   On 23-SEP-2024, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection prefilled syringe, strength 25u/0.5ml, 1 dose, administered for prophylaxis (route of administration and anatomical site of injection were not provided; lot number T989614 is an invalid lot number for hepatitis a vaccine, inactivated [VAQTA], expiration date 23-AUG-2024) (Expired product administered).   No additional adverse event (AE) was reported for this patient.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired MENQUADFI vaccine had been administered to a patient with no reported adverse event; Initial information received on 09-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics whom expired meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] vaccine had been administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Sep-2024, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (strength, Lot number not reported) expiry date: 6-aug-2024 via unknown route in unknown administration site for immunization and is reported expired menquadfi vaccine had been administered to a patient with no reported adverse event (expired product administered). (Latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error,
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered to a patient under the recommended age of 65 with no reported adverse event; Initial information received on 09-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 63-year-old female patient and is reported influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] was administered to a patient under the recommended age of 65 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2024, the patient received a 0.7 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe of lot UT8437AA and expiry date: 30-Jun-2025 (frequency: once) via intramuscular route in the left deltoid for immunization and it administered to a patient under the recommended age of 65 with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given Fluzone yesterday instead of Fluzone High Dose with no reported adverse event; inadvertently administered fluzone quadrivalent to a 70 year old male patient with no reported adverse event; Initial information received on 10-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 70 years old male patient where patient was given Influenza usp trival a-b subvirion no preservative vaccine [Fluzone] yesterday instead of Influenza usp trival a-b high dose subvirion vaccine [Fluzone high dose] with no reported adverse event and inadvertently administered fluzone quadrivalent to a 70 year old male patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2024, the patient received a dose of suspect Influenza usp trival a-b subvirion no preservative vaccine Suspension for injection (strength- standard) (lot- U8442AA) via intramuscular route in the deltoid nos (not specified) (dose and expiration date: not provided) for Immunisation and patient was given fluzone yesterday instead of fluzone high dose with no reported adverse event (wrong product administered) and inadvertently administered fluzone quadrivalent to a 70 year old male patient with no reported adverse event (product administered to patient of inappropriate age) (latency- same day for both events).  On an unknown date, dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported (dose, strength and expiration date: not provided) for Immunisation.  Information regarding batch number and expiration date (Fluzone high dose) corresponding to the one at a time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: team member inadvertently administered twice the recommended dose of FLUZONE HD to several patients with no reported adverse event; Initial information received on 10-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 5 patients with an unknown age and unknown gender patient(s) where reporter reported team member inadvertently administered twice the recommended dose of Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] to several patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation and team member inadvertently administered twice the recommended dose of fluzone hd to several patients with no reported adverse event (extra dose administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PENTACEL was administered to an 8 year old patient, with no reported adverse event; Initial information received on 10-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 years old female patient whom had received diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Aug-2024, the 8 year old patient received a 0.5 ml dose (dose 4) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection frequency: once, strength: standardization (expiry date, lot number not reported) via intramuscular route in the right deltoid as Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: accidentally administered only the HIB component of PENTACEL to a patient, and it was reconstituted with sterile water with no reported Adverse event; Initial information received on 10-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who accidentally got administered only the hib component of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] to a patient, and it was reconstituted with sterile water with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site for Immunisation and accidentally administered only the hib component of pentacel to a patient, and it was reconstituted with sterile water with no reported adverse event (single component of a two-component product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: Drug Exposure During Pregnancy; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435) for prophylaxis.   On 09-SEP-2024, the patient received the 1st dose of Arexvy. On 09-SEP-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 10-SEP-2024 A 39 year old female patient who was 34 weeks into their gestation accidentally received a dose of Arexvy on and wanted to know if there was any information about the usage of Arexvy in these patients, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. They provided information about the patient, vaccine and patient and consented to receive follow up. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3, PPV
Symptoms: Erythema, Fatigue, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: 9-9-24 evening - felt feverish, tired. Right arm "hot" at injection site. Swollen. Next day, right arm had a red "band", around arm & down back of arm - rash. Hives? Itchy, swollen. Applied cortison; Benedryl topical. Little effect. Took oral Benedryl at bedtimes, Twice Approx 4 days to resolve.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3, PPV
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: 9-9-24 evening - felt feverish, tired. Right arm "hot" at injection site. Swollen. Next day, right arm had a red "band", around arm & down back of arm - rash. Hives? Itchy, swollen. Applied cortison; Benedryl topical. Little effect. Took oral Benedryl at bedtimes, Twice Approx 4 days to resolve.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3, PPV
Symptoms: Asthenia, Chills, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Morning after vaccination, woke feverish. Fever, chills, shaking intermittent. Lasted ~ 36 hours. Weakness, body aches, very tired - 3 days. Unusual! Right arm shot area still painful. At worst, pain radiated down to fingers. Trouble raising arm! Arm weak - not normal! Left arm no problems.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3, PPV
Symptoms: Muscular weakness, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Morning after vaccination, woke feverish. Fever, chills, shaking intermittent. Lasted ~ 36 hours. Weakness, body aches, very tired - 3 days. Unusual! Right arm shot area still painful. At worst, pain radiated down to fingers. Trouble raising arm! Arm weak - not normal! Left arm no problems.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Electrocardiogram, Fatigue, Headache, Heart rate irregular
Clinical narrative: normal - but never had with earlier Covid vaccines - tired feeling, slight headache - that night (AM) 9-1 - felt irregular heartbeat - off - on for next 12 hours? Had EKG, my Doctor wanted a heart  monitor also 72 hours. heart beat later 8-31 was off - I could feel it, checking pulse with my finger it was 3 beat pause - 3 beats pause - 4-5 etc -\ EKG was 9-3 My doctor requested a heart monitor - put on 9-10 off 9-14 -(72 hours) Turn in on 9-16 Results of course ? unknown - 9-14