chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Product administered at inappropriate site, Respiratory tract congestion
Clinical narrative: Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later; a bit of sore throat; Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 at 10:00 as dose 1, single (Lot number: lm2212) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIPITOR; BYSTOLIC; COQ 10; VITAMIN B12 [VITAMIN B12 NOS]. The patient also took other concomitant therapy. The following information was reported: PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious), ERYTHEMA (non-serious) all with onset 12Sep2024 at 14:00, outcome "not recovered" and all described as "Within 4 hours of injection my arm swelled to half a tennis ball and is highly red and inflamed"; OROPHARYNGEAL PAIN (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "a bit of sore throat"; RHINORRHOEA (non-serious) with onset 12Sep2024 at 14:00, outcome "not recovered", described as "within same 4 hours started to have runny nose--constant dripping as of nearly 48 hours later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling, inflammation, rhinorrhoea, oropharyngeal pain, erythema.  Additional information: Patient was reported within 4 hours of injection her arm swelled to half a tennis ball and was highly red and inflamed. Within same 4 hours started to have runny nose-constant dripping as of nearly 48 hours later. Also a bit of sore throat. she took a COVID test day after and it was negative. Patient did not receive any other vaccines on the same date as the vaccine, patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine, Patient was patient taking any other medications within 2 weeks of the event starting. The patient also took other concomitant therapy with Multi Vitamin.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: having muscle pains; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 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: MYALGIA (non-serious), outcome "unknown", described as "having muscle pains".  Additional information: Patient was having muscle pains which he never had until he got Pfizer Covid 19 vaccine shot. He wanted to know if it was normal and would go away.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report received from a Consumer or other non HCP from medical information team and a sales representative.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 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: GUILLAIN-BARRE SYNDROME (medically significant) with onset Sep2024, outcome "unknown".  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, COVID19, COVID19
Symptoms: Computerised tomogram, Fall, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report received from a Consumer or other non HCP from medical information team and a sales representative.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 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: GUILLAIN-BARRE SYNDROME (medically significant) with onset Sep2024, outcome "unknown".  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, COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report received from a Consumer or other non HCP from medical information team and a sales representative.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 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: GUILLAIN-BARRE SYNDROME (medically significant) with onset Sep2024, outcome "unknown".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Fatigue
Clinical narrative: Tested covid positive; Tested covid positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 06Sep2024 as dose 1, single (Lot number: LM2215) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&j vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Sep2024, outcome "unknown" and all described as "Tested covid positive". The patient received Pfizer's new Covid vaccine on 06Sep2024 at the (Address withheld). Sore throat started on 10Sep2024, and on 12Sep2024 progressed to cough, congestion, runny nose, fever, headache, chills & fatigue. The patient tested Covid positive on 13Sep2024. The patient reported that he reacted to 1st J&J vaccine, and he has had every Pfizer booster since. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2024) Positive.
Sex: U
Vaccine: UNK
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Tested covid positive; Tested covid positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 06Sep2024 as dose 1, single (Lot number: LM2215) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&j vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Sep2024, outcome "unknown" and all described as "Tested covid positive". The patient received Pfizer's new Covid vaccine on 06Sep2024 at the (Address withheld). Sore throat started on 10Sep2024, and on 12Sep2024 progressed to cough, congestion, runny nose, fever, headache, chills & fatigue. The patient tested Covid positive on 13Sep2024. The patient reported that he reacted to 1st J&J vaccine, and he has had every Pfizer booster since. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2024) Positive.
Sex: U
Vaccine: UNK
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested covid positive; Tested covid positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 06Sep2024 as dose 1, single (Lot number: LM2215) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&j vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Sep2024, outcome "unknown" and all described as "Tested covid positive". The patient received Pfizer's new Covid vaccine on 06Sep2024 at the (Address withheld). Sore throat started on 10Sep2024, and on 12Sep2024 progressed to cough, congestion, runny nose, fever, headache, chills & fatigue. The patient tested Covid positive on 13Sep2024. The patient reported that he reacted to 1st J&J vaccine, and he has had every Pfizer booster since. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2024) Positive.
Age: 7.0
Sex: U
Vaccine: FLUC3
Symptoms: Incorrect dose administered, Patient uncooperative
Clinical narrative: jerked while being given the vaccine; only received half the dose (about 0.2 ml left in syringe); This spontaneous case initially received on 09-Sep-2024, was reported by a health professional and concerns a child patient.  No information about patient history and allergy.  Administration of company suspect drug: On 09-Sep-2024, the patient received Flucelvax (TIV) for Influenza prophylaxis, dosage less than 0.5 ml, about 0.2 ml left in syringe, route of administration: Not reported, Anatomical location: Deltoid unknown if left or right, Lot number: No batch number available with no consent to follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 09-Sep-2024, the patient experienced jerked while being given the vaccine (outcome: Not Reported), only received half the dose (about 0.2 ml left in syringe) (outcome: Not Reported).  The immunizer reported to the pharmacist that the child jerked while being given the vaccine and the child only received half the dose (about 0.2 ml left in syringe).  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non-serious and did not provide causality assessment.; Reporter's Comments: the event of jerked while being given the vaccine considered as related and jerked while being given the vaccine considered as not related.
Sex: M
Vaccine: HPV9
Symptoms: Abnormal behaviour, Grunting, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Customer calling to report the HCP inadvertently administered a GARDASIL 9 Vaccine to her 18 month old son.; he is not feeling himself and has been grunting; Mother states her son has been experiencing a "Fever, he is not himself and has been grunting."; he is not himself; This spontaneous report has been received from a consumer regarding an 18-month-old male patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On an unspecified date, the patient inadvertently received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (product administered to patient of inappropriate age).  Since 09-SEP-2024, the patient experienced fever (pyrexia), he was not himself (ill-defined disorder) and had been grunting. No additional details provided. At the time of the reporting, the outcome of the events was unknown.  Causal relationship between the suspect vaccine and the events was unknown.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pharyngeal swelling, Swelling
Clinical narrative: Swollen neck and throat leading to a sore throat; Swollen neck and throat leading to a sore throat; Swollen neck and throat; This serious case was reported by a consumer via sales rep and described the occurrence of neck swelling in a 55-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of swelling (1st dose received on an unknown date and experienced sore throat and throat swelling).   On 06-SEP-2024, the patient received the 2nd dose of Shingles vaccine (right arm). On 10-SEP-2024, 4 days after receiving Shingles vaccine, the patient experienced neck swelling (Verbatim: Swollen neck and throat leading to a sore throat) (serious criteria other: serious as per reporter), sore throat (Verbatim: Swollen neck and throat leading to a sore throat) (serious criteria other: serious as per reporter) and throat swelling (Verbatim: Swollen neck and throat) (serious criteria other: serious as per reporter). The outcome of the neck swelling, sore throat and throat swelling were resolving.   The reporter considered the neck swelling, sore throat and throat swelling to be related to Shingles vaccine.     The company considered the neck swelling, sore throat and throat swelling to be unrelated to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR115276   Additional Information: GSK Receipt Date: 10-SEP-2024 The patient received a subsequent dose and experienced swollen neck and throat leading to a sore throat.; Sender's Comments: Swelling, Oropharyngeal pain and Pharyngeal swelling are unlisted events which are considered unrelated to GSK Shingles vaccine. US-GSK-US2024AMR115276:
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy affecting R facial nerve.  Treated with prednisone and valcyclovir.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Bile acids, Dizziness, Dyspnoea, Hepatic enzyme, Loss of personal independence in daily activities
Clinical narrative: *Unsure of brand of vaccine* I started feeling dizzy and itchy + out of breath shortly after the vaccine. The itching truly began on Saturday, September 7th, and is relentless. Labs for cholestasis are normal, Benadryl doesn?t work, no meds have worked. I haven?t slept in a week or been able to do much of anything.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Sleep disorder, Treatment failure
Clinical narrative: *Unsure of brand of vaccine* I started feeling dizzy and itchy + out of breath shortly after the vaccine. The itching truly began on Saturday, September 7th, and is relentless. Labs for cholestasis are normal, Benadryl doesn?t work, no meds have worked. I haven?t slept in a week or been able to do much of anything.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Paraesthesia, X-ray dental
Clinical narrative: Numbness and paresthesia right side of face especially corner of mouth. Began late in day 8/27/2020. Visited dentist for exam and x-ray on 8/29/2024. Visited dentist again 9/12/2024 for exam and panogram x-ray. Referred to oral surgeon. Kept in touch after each dental visit with PCP Dr. who prescribed Medrol dose pack started 9/16.
Age: 67.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient reports he has had multiple nauseous and vomiting episodes since vaccination. On 9/10 he threw up 4 times, on 9/11 he threw up 2 times, on 9/15 he threw up 3 times, and on 9/16 he threw up 5 times.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Headache, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: the patient received the imz on Thursday and reported to the pharmacy on the following Monday her imz arm was swollen, red, itching, hot to touch, and  tight.  The patient also said she had a fever and headache.  I recommended for her to use Allegra 180mg once daily, 50mg of Benadryl at bedtime, 20mg Pepcid daily, 1% Hydrocortisone Cream 3 to 4 times daily and a cold ice pack. The patient's doctor was notified and they told the patient to follow what they have been doing from the pharmacy
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Skin tightness, Skin warm
Clinical narrative: the patient received the imz on Thursday and reported to the pharmacy on the following Monday her imz arm was swollen, red, itching, hot to touch, and  tight.  The patient also said she had a fever and headache.  I recommended for her to use Allegra 180mg once daily, 50mg of Benadryl at bedtime, 20mg Pepcid daily, 1% Hydrocortisone Cream 3 to 4 times daily and a cold ice pack. The patient's doctor was notified and they told the patient to follow what they have been doing from the pharmacy
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient came to community flu clinic and filled out vaccine consent form. She was 61, but when the time came to administer her vaccine, the High Dose shot was pulled from the box in error and administered. She was informed of the error shortly after administration, and later in the day her primary care Dr. was called and informed as well. She has since been by the pharmacy and reports no ill effects so far.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PATIENT COMPLAINS OF ARM HURTING DOWN INTO THE ELBOW. NO REDNESS OR SWELLING AT SITE OF VACCINE AT THE TIME OF REPORTING
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED ABOUT 3 MINUTES AFTER RECEIVING VACCINATION WHILE SHOPPING IN THE STORE.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Swelling in arm, rock hard arm, rash/redness large area on arm, heart palpitations, chest pain, left arm pain into jaw. Increased blood pressure, heart rate and thought was having a heart attack. Cardiologist says heart is fine but inflammation and nerve pain could be from shot
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Heart rate increased, Induration, Inflammation, Neuralgia
Clinical narrative: Swelling in arm, rock hard arm, rash/redness large area on arm, heart palpitations, chest pain, left arm pain into jaw. Increased blood pressure, heart rate and thought was having a heart attack. Cardiologist says heart is fine but inflammation and nerve pain could be from shot
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain in jaw, Palpitations, Peripheral swelling, Rash
Clinical narrative: Swelling in arm, rock hard arm, rash/redness large area on arm, heart palpitations, chest pain, left arm pain into jaw. Increased blood pressure, heart rate and thought was having a heart attack. Cardiologist says heart is fine but inflammation and nerve pain could be from shot
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Measles, Pyrexia, Rash
Clinical narrative: We were told that she has full blown measles from the vaccine. Full body rash head to toe. 102 fever for the last 3 days. Rash started small on face and then rapidly progressed to full body by this morning. Pictures were obtained at hospital.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site swelling, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Left arm red and swollen. Hot to touch. Swelling to elbow. Swollen lymph nodes in arm pit. fever. Marked swollen area on left arm.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Fall, Hypotension, Syncope
Clinical narrative: Patient fainted following administration of both fluad and spikevax. Patient has needle phobia and remained seated after administration. When patient got up to leave, she fell when walking. Paramedics followed up and patient had low blood pressure roughly 90/65
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Pain, Tremor
Clinical narrative: 3am body shakes, soreness all over temp 98.5, 8am temp 100.5,  5pm temp 98.5
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Paraesthesia, Paraesthesia oral, Swelling face
Clinical narrative: Patient had swelling of the face and tingling of tongue and lips
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient got 2 flu vaccines ( FLUAD ) , patient got the first dose on 08/16/24 and came and asked again and we administer another FLuad on September 16, we did not know that patient already received it. Patient had issue with memory and when we asked, he said he got shingrix in August .
Age: 81.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient got 2 flu vaccines ( FLUAD ) , patient got the first dose on 08/16/24 and came and asked again and we administer another FLuad on September 16, we did not know that patient already received it. Patient had issue with memory and when we asked, he said he got shingrix in August .
Age: 40.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Aphthous ulcer, Cough, Pain
Clinical narrative: Day 1: 1-2 aphthous ulcers associated with some pain (3/10) requiring PRN ibuprofen, oral benzocaine application, and normal diet. Day 2: 5-6 aphthous ulcers associated with moderate pain (6/10) requiring PRN ibuprofen, benzocaine application, and semi-solid diet for comfort. Day 3: 7-8 aphthous ulcers associated with severe pain (7/10) requiring scheduled ibuprofen, benzocaine application, and liquid diet for comfort.  Day 4: No new ulcers. Some existing ulcers resolved. No medication required. Day 5: All ulcers resolved. Associated with a cough that started on Day 1 and is lingering to date. I don't believe the cough is related to the vaccine. No fever at any point during the 5 day period. My husband also had oral ulcer (2 in #) on Day 2 of my receiving the vaccine. Did not require any medication and resolved spontaneously within 24 hours. No cough.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Left arm small wheal with soreness and erythema, initially mistaken for a bruise. About 1.5 cm x 3 cm.  Deveveloped within 12 hrs of vaccine administration. Previously have received 2 initial Moderna Covid vaccines in 2021 and a booster in 2022 and 2023, I believe both Moderna. Only tiredness and mild muscular soreness previously. Pretty sure first time having Pfizer. Also received multivalent flu vaccine in opposite (right arm) same day, but this has also been done prior without complication.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Pt was administered an expired (09/15/2024) dose of MMR vaccine on 09/16/2024.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest pain, Dysphonia, Pruritus
Clinical narrative: PATIENT REQUESTED TO RECEIVE 2 VACCINES TODAY; INFLUENZA HD AND COVID 24-25. I ADMINISTERED BOTH TO HER AND SHE STATED SHE HAS HAD NO REACTIONS TO THEM IN THE PAST. SHE HAD TO WAIT FOR A RIDE IN OUR WAITING ROOM AND ABOUT 15-20 MINUTES AFTER VAXINATION SHE CAME TO THE COUNTER STATING SHE WAS FEELING A BURNING IN HER CHEST. SHE SAID IT WAS THE SAME SENSATION THAT SHE HAD EXPERIENCED WHEN SHE HAD A TRUE ANAPHYLAXIS REACTION WHILE IN THE HOSPITAL. SHE STATED THAT SHE WAS GIVEN BENADRYL PREVIOUSLY. I ADMINISTERED BENADRYL 25MG CAPSULES TWICE TO HER, OUT OF THE EMERGENCY BAG, WHILE SHE WAS HERE AND SHE STATED SHE FELT BACK TO NORMAL AFTER ABOUT 30 MINUTES. I OFFERED HER AN EPI PEN FROM THE EMERGENCY BAG AND SHE REFUSED BECAUSE OF HER HISTORY OF AFIB. SHE WAS CONCERNED ABOUT HER HEART RATE. I OFFERED TO CALL AN AMBULANCE FOR HER IF NEEDED, SHE STATED IT WAS NOT NESSESARY. SHE SAID THAT IF SHE NEEDED ONE WHEN SHE GOT HOME SHE WOULD CALL ONE HERSELF. I CHECKED ON HER MULTIPLE TIMES WHILE IN THE PHARMACY AND AGAIN BEFORE SHE LEFT THE STORE. EVERY TIME SHE STATED SHE FELT BACK TO NORMAL.  WHEN SHE STATED SHE FELT THE SAME SYMPTOMS TO HER ANAPHYLAXIS EXPERIENCE I ASKED WHAT SHE WAS FEELING. SHE STATED A BURNING IN HER CHEST LIKE BEFORE, AND SHE COULD FEEL HER VOICE BECOMING SCRATCHY AND ITCHY.
Age: 20.0
Sex: M
Vaccine: FLUC4, HPV9
Symptoms: Dizziness, Dyskinesia, Feeling abnormal, Loss of consciousness, Mydriasis
Clinical narrative: pt came into to receive a flu IMZ he had scheduled online. he wanted to receive any IMZs he was due for. Per database pt needed FLU, COVID, TDAP, and HPV imzs. pt received FLUCELVAX IMZ 1st on left deltoid. pt said he was ok and I gave him the next shot, Gardasil, about an inch below FLU IMZ. pt said he felt odd. he immediately asked for water. I grabbed a water from the pharmacy and asked the tech to bring me some snacks. Pt was still alert when I went back into IMZ booth. He didn't want any water. He stated he felt like he was going to pass out. I asked him if he has passed out before and he told me he almost did when he tried to give blood. his eyes were dilated and he then passed out. I was able to maintain pt in his chair. his body jerked once and about 5-7 seconds later he opened his eyes. I checked his bp-100/66, pulse-85. he apologized for fainting. I had him remain in the chair and eat snacks. He said he probably should have ate more before getting the vaccines. I did not give him the 2 remaining IMZs. he agreed that he needed to wait to receive more IMZS. we paged pts dad and he came over to pharmacy. pts dad left after a few mins after he knew his son was ok to continue shopping. we had pt move to bench in front of pharmacy. he ate more snacks. about 25 mins later he came to pharmacy window and said he was feeling ok and was ready to leave. he left. I called pt about 8pm that same day to check on him. He told me he felt fine. I told him to contact me if any changes or if he needs anything.
Age: 20.0
Sex: M
Vaccine: FLUC4, HPV9
Symptoms: Syncope
Clinical narrative: pt came into to receive a flu IMZ he had scheduled online. he wanted to receive any IMZs he was due for. Per database pt needed FLU, COVID, TDAP, and HPV imzs. pt received FLUCELVAX IMZ 1st on left deltoid. pt said he was ok and I gave him the next shot, Gardasil, about an inch below FLU IMZ. pt said he felt odd. he immediately asked for water. I grabbed a water from the pharmacy and asked the tech to bring me some snacks. Pt was still alert when I went back into IMZ booth. He didn't want any water. He stated he felt like he was going to pass out. I asked him if he has passed out before and he told me he almost did when he tried to give blood. his eyes were dilated and he then passed out. I was able to maintain pt in his chair. his body jerked once and about 5-7 seconds later he opened his eyes. I checked his bp-100/66, pulse-85. he apologized for fainting. I had him remain in the chair and eat snacks. He said he probably should have ate more before getting the vaccines. I did not give him the 2 remaining IMZs. he agreed that he needed to wait to receive more IMZS. we paged pts dad and he came over to pharmacy. pts dad left after a few mins after he knew his son was ok to continue shopping. we had pt move to bench in front of pharmacy. he ate more snacks. about 25 mins later he came to pharmacy window and said he was feeling ok and was ready to leave. he left. I called pt about 8pm that same day to check on him. He told me he felt fine. I told him to contact me if any changes or if he needs anything.
Age: 21.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Condition aggravated, Loss of personal independence in daily activities, Migraine, Wrong product administered
Clinical narrative: I specifically booked to get the Novavax vaccine online, and was told that this was the closest pharmacy that had it. I already had a bad migraine and  Covid vaccines generally tend to do a number on me, and the Novavax vaccine has been proven to be more effective as opposed to Pfizer or Moderna, as well as having fewer side effects. Since I'm high risk and was already feeling bad, I wanted to go with Novavax. I explicitly selected that on the questionnaire, and I had also put that I had chronic health conditions. When I got there, I got my vaccine and I thought everything was fine. 2 days later my migraine develops an entirely different pattern. What had luckily been a low grade dull but occasionally sharp pain had turned into an ice pick literally drilling into my head.  I mean i was immobilized. My meds didn't even make a dent, I just had to wait it out. And while this sort of pain and migraine attack has happened before, I was weirded out because usually the "lesser" migraines (the ones that tend to last the longest) tend to stay at one stable level and transitions happen slowly if they do. I remembered that I did my vaccines a couple days back and went to go read the receipt emails out of curiosity i guess? idk maybe i thought it would make me feel better hold on it (the website) just told me i have 5 minutes left in my session long story short i read the email and learned that they had actually given me the Morderna vaccine instead of the Novavax. i'm extremely angry about this for multiple reasons. first of all, no one should EVER inject someone with something without their permission, that's entirely unethical. secondly, i have a lower resistance to a disease that has a high chance of doing me great harm. and thirdly, i have ptsd related to medical malpractice committed against me in the past , and this event almost mirrored what happened last time, and last time I quite literally nearly died. this has caused me great distress. AND my migraine is worse.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dyspnoea, Erythema, Pruritus, Skin irritation
Clinical narrative: Pt had the COVID and Flu shots Saturday. Per pt, had difficulty in breathing the day after for 1 day, and has redness, itching, and irritation on the left arm until today; pt used Claritin and the itchiness subsided.
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient had swelling and erythema of her thigh after receiving Vaxelis. It resolved on its own without medical intervention
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Feeling abnormal, Wheezing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: She said Wheezing like she had ran a marathon not allergic reaction breathing difficulties, Other Vaccines:  VaccineTypeBrand: Fluzone HD; Manufacturer: ; LotNumber: UT8419BA; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: She said Wheezing like she had ran a marathon not allergic reaction breathing difficulties, Other Vaccines:  VaccineTypeBrand: Fluzone HD; Manufacturer: ; LotNumber: UT8419BA; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Urticaria
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Headache-Medium, Additional Details: Pt reports rash all over the entire body from vaccine.  no history with allergies. rash started in leg and spread over entire body. hives and headache, Other Vaccines:  VaccineTypeBrand: Pfizer 2024-2025 Covid; Manufacturer: pfizer; LotNumber: lm2222; Route: IM; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Headache, Injection site erythema, Pruritus, Rash, Urticaria
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Headache-Medium, Additional Details: Pt reports rash all over the entire body from vaccine.  no history with allergies. rash started in leg and spread over entire body. hives and headache, Other Vaccines:  VaccineTypeBrand: Pfizer 2024-2025 Covid; Manufacturer: pfizer; LotNumber: lm2222; Route: IM; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dry throat, Haemorrhoidal haemorrhage, Nausea
Clinical narrative: Systemic: Diarrhea-Severe, Systemic: blood in stool-Severe, Systemic: Vomiting-Mild
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Vaccination site haemorrhage, Vaccination site pain, Vomiting, Weight
Clinical narrative: Systemic: Diarrhea-Severe, Systemic: blood in stool-Severe, Systemic: Vomiting-Mild
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Flatulence, Full blood count normal, Nausea
Clinical narrative: Systemic: Diarrhea-Severe, Systemic: blood in stool-Severe, Systemic: Vomiting-Mild
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Diarrhea-Severe, Systemic: blood in stool-Severe, Systemic: Vomiting-Mild
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Haematochezia, Vomiting
Clinical narrative: Systemic: Diarrhea-Severe, Systemic: blood in stool-Severe, Systemic: Vomiting-Mild
Age: 28.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Asthenia, Cough, Dry mouth, Dyschromatopsia, Dyspnoea
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient described this as rapid <15 mins reaction. started with extreme burning sensation of the vaccinated arm, followed by chest tightness and shortness of breath and ending with visual discoloration. Patient had experienced negative effects from COVID vaccines in the past, however insisted she recieved this vaccine AMA.
Age: 28.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Headache, Immediate post-injection reaction, Impaired driving ability, Incorrect route of product administration, Injection site haemorrhage
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient described this as rapid <15 mins reaction. started with extreme burning sensation of the vaccinated arm, followed by chest tightness and shortness of breath and ending with visual discoloration. Patient had experienced negative effects from COVID vaccines in the past, however insisted she recieved this vaccine AMA.
Age: 28.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Injection site pain, Nausea, Neck pain, Visual impairment
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient described this as rapid <15 mins reaction. started with extreme burning sensation of the vaccinated arm, followed by chest tightness and shortness of breath and ending with visual discoloration. Patient had experienced negative effects from COVID vaccines in the past, however insisted she recieved this vaccine AMA.
Age: 28.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Burning sensation, Chest discomfort, Dyspnoea
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient described this as rapid <15 mins reaction. started with extreme burning sensation of the vaccinated arm, followed by chest tightness and shortness of breath and ending with visual discoloration. Patient had experienced negative effects from COVID vaccines in the past, however insisted she recieved this vaccine AMA.
Age: 21.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant calling to report a 21 year old patient was inadvertently administered both the PROQUAD and VARIVAX on the same day.  No symptoms reported and no additional details provided.  This agent is filing a full AE as there has been no foll; No symptoms reported and no additional details provided; This spontaneous report was received from a medical assistant (MA) concerning a 21-year-old male patient.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    On 06-SEP-2024, the patient was inadvertently vaccinated with both doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # X009131, expiration date: 24-SEP-2024 (dose, route and frequency were not reported) for prophylaxis and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) Lot# X012268, expiration date: 30-APR-2025 (dose, route, and frequency were not reported) for prophylaxis (accidental overdose).      No symptoms reported and no additional details provided (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional adverse event; Nurse reported that a patient received MMR II that was reconstituted with saline instead of Merck diluent.; This spontaneous report was received from nurse and refers to a unspecified age and gender patient.   No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 30-AUG-2024, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, 1 dose, lot #x025827, expiration date: 31-OCT-2025, administered for prophylaxis (strength, exact dose, and anatomical route of administration were not provided). It was reported that patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection that was reconstituted with saline instead of Merck diluent (product preparation error).   No additional adverse event.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Second Dose Two Weeks Early; Initial report received on 14-Aug-2024.  A pharmacist reported that a 19-year-old female patient (race and ethnicity not provided) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization early.  Medical history and concomitant medications were not reported.   On 25-Jul-2024, the patient received the first dose of HEPLISAV-B (Lot number 944916, expiration date 29-Oct-2026, and NDC 43528-0003-05) intramuscularly in the left deltoid.   On 14-Aug-2024, 21 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B early (Lot number 944941, expiration date 15-Dec-2026, NDC 43528-0003-05; injection site unknown) intramuscularly. The patient did not have any additional side effects as a result.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received a Dose of HEPLISAV-B that Expired; Initial report received on 21-Aug-2024.  A pharmacist reported that a 33-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications were not reported.  On 20-Aug-2024, the patient received the first dose of HEPLISAV-B (Lot number 939677, expiration date 14-May-2024, and NDC 43528-003-05; route and injection site not reported). The dose was expired. No adverse reactions were reported.  No other information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose and Has Not Received The Next Dose; Initial report received on 26-Aug-2024  A registered pharmacist reported that a patient (sex, age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medication were not reported.    On an unspecified date in 2001, the patient received 3 doses of ENGERIX-B.   On 22-Jul-2024, a dose of HEPLISAV-B (lot #, expiration date, and NDC # 4358-002-01, site not reported) was administered to the patient.  At the time of report, the patient had not received a second dose of HEPLISAV-B.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received The First Dose, and Second Dose Given 8 Days Early; Initial report received on 27-Aug-2024.  A licensed practical nurse reported that a female (age, race and ethnicity not provided) employee received their second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 8 days early.  Medical history and concomitant medication were not reported.    On an unknown date, dose 1 of HEPLISAV-B (lot #, expiration date, and NDC #, site not reported) was administered.  On 27-Aug-2024, dose 2 of HEPLISAV-B (lot #, expiration date, and NDC # 4358-002-01, site not reported) was administered.  This dose was given 8 days early from the due date of 05-Sep-2024.    No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose, Have Not Received Second Dose Yet; Initial report received on 27-Aug-2024.  A pharmacist reported that a patient (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose after four months.  Medical history and concomitant medications were not reported.   On 24- Apr-2024, the patient received the first dose of HEPLISAV-B (lot #, expiration date, injection site, and route unknown, and NDC # 43528-002-01) from a pharmacist.  As of the date of reporting, the patient has not received the second dose.   No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site rash
Clinical narrative: A very odd rash in a large area surrounding the vaccine injection spot; This is a spontaneous report and received from Other HCPs from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml, single (Lot number: HP7364, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "A very odd rash in a large area surrounding the vaccine injection spot".  Additional information: The patient had an adverse effect. There was a very odd rash in a large area surrounding the vaccine injection spot, almost wrapped completely in a strip around the upper arm. NDC number of Prevnar 20 was 00005200010.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400255809 same reporter/suspect vaccine/event; different patient;
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disease; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset 2024, outcome "unknown", described as "autoimmune disease". Therapeutic measures were taken as a result of autoimmune disorder. The patient reported he was prescribed tofacitinib citrate (XELJANZ) 10 mg to treat an autoimmune disease he got from  taking the Pfizer COVID-19 vaccine booster.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400256518 same patient, different drug/event;
Sex: U
Vaccine: TDAP
Symptoms: Ophthalmic migraine, Vestibular disorder
Clinical narrative: ocular migraines; vestibular issues; Initial information received on 21-Aug-2024 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves an unknown age/gender patient who experienced ocular migraines and vestibular issues after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In May 2021, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (lot U6855AA) (dose, strength, expiry and route: unknown) in unknown administration site for Prophylactic Vaccination.  In 2021 the patient developed a non-serious ocular migraines (ophthalmic migraine) and vestibular issues (vestibular disorder) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (ocular migraines, vestibular issues).  At time of reporting, the outcome was Unknown for the events (ocular migraines, vestibular issues).
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Ophthalmic migraine, Vestibular disorder
Clinical narrative: ocular migraines; vestibular issues; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 64-year-old female patient who experienced ocular migraines and vestibular issues after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-May-2021, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U6855AA (expiry date: not reported) via unknown route in unknown administration site as immunization.  On unknown date in 2021 the patient developed ocular migraines (ophthalmic migraine) and vestibular issues (vestibular disorder) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  Reportedly, Caller is not blaming the issues on the vaccine but just is looking if there were any other adverse events reported. She also inquired if it contains thimerosal and what were the other ingredients in it.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events ocular migraines, vestibular issues.  At time of reporting, the outcome was Unknown for the event ocular migraines and vestibular issues.