chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: pentacel administered today expired on 09/11/2022, with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 months old female patient and it was reported that  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] administered today expired on 09/11/2022, with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE , once (lot : UJ571AAA; expiry date: 11-Sep-2022)  via intramuscular route in unknown administration site for immunization.  t was reported that Pentacel administered was administered on 15-Sep-2022 and it expired on 09/11/2022, with no reported adverse event" (expired product administered) (latency: same day)   Action taken : not applicable.  Outcome: unknown   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: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was inadvertently administered a second dose of MENQUADFI, seven days after he received a dose of MENQUADFI with no adverse event; patient was inadvertently administered a second dose of MENQUADFI, seven days after he received a dose of MENQUADFI with no adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was inadvertently administered a second dose of menquadfi, seven days after he received a dose of menquadfi with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Sep-2022, the patient received 0.5 mL of dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation, strength and lot number not reported) via intramuscular route in the right deltoid for immunization. On 19-Sep-2022, he also received 0.5 mL of dose 2 of the same vaccine (formulation, strength not reported; lot U7218AA and expiry date: 22-Feb-2024) via intramuscular route in the right deltoid for immunization.   On 19-Sep-2022, (latency: same day) the patient was inadvertently administered a second dose of menquadfi, seven days after he received a dose of menquadfi with no adverse event (accidental exposure to product) and (inappropriate schedule of product administration) following the 2 dose administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  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: F
Vaccine: UNK
Symptoms: Vaccination site discolouration
Clinical narrative: A "halo" on the arm where the vaccine was administered; This spontaneous case was received on 22-Aug-2022 from a pharmacist via Agency (reference number: SEQW22-02391) and concerned a 70-year-old, female patient.  The patient's medical history was not reported. The patient was not taking any concomitant medications.   On 22-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 346357 and expiry date 18-May-2023.  On the same day, after receiving Fluad Quadrivalent, the patient experienced a 'halo' on the arm where the vaccine was administered. Two hours after vaccination the patient called and complained of the event. No treatment measures were performed.   At the time of initial reporting on 22-Aug-2022, the patient had not recovered from the event.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 70-year-old female patient experienced vaccination site discolouration (reported as a 'halo' on the arm where the vaccine was administered) after vaccination with the suspect Fluad Quadrivalent vaccine. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: A 70-year-old female patient experienced vaccination site discolouration (reported as a 'halo' on the arm where the vaccine was administered) after vaccination with the suspect Fluad Quadrivalent vaccine. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Headache, Nausea, Pyrexia
Clinical narrative: Started with chills, headache followed by fever, nausea and trouble breathing. Ending about 5 hours later when I feel asleep.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: WRONG VACCINE WAS GIVEN
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Administered covid bivalent instead of flu shot patient has not received bivalent vaccine yet so communicated the incident to them.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram head, Magnetic resonance imaging head, Vertigo, Vomiting
Clinical narrative: Flu shot. Not sure which type given. Sudden Severe vertigo and vomiting requiring two ER visits and hospitalization for 3 days. Started less than 24 hours after vaccine given.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Oesophageal achalasia
Clinical narrative: Aches and joint pain, followed by fever/chills and shaking. Lasted 12 hours. Lingering headache and tiredness.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Aches and joint pain, followed by fever/chills and shaking. Lasted 12 hours. Lingering headache and tiredness.
Age: 55.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Wrong technique in product usage process
Clinical narrative: a WHEAL WAS NOT CREATED, HAD TO ADMINISTER A SECOND DOSE TO OPPOSITE ARM TO CREATE A WHEEL.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Dyspnoea, Gait inability, Headache
Clinical narrative: Reaction started within 4 hours of injection and increased all night to a severe level. It was worse than when I got Covid last year. Pain in all muscles, severe headache, chills and fever, swelling in mouth, tongue, difficulty breathing, dizziness, unable to walk until noon next day, and then only with a walker. Severe nausea and vomiting, heaving. Unable to sleep all night.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Mouth swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Reaction started within 4 hours of injection and increased all night to a severe level. It was worse than when I got Covid last year. Pain in all muscles, severe headache, chills and fever, swelling in mouth, tongue, difficulty breathing, dizziness, unable to walk until noon next day, and then only with a walker. Severe nausea and vomiting, heaving. Unable to sleep all night.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Retching, Swollen tongue, Vomiting, Walking aid user
Clinical narrative: Reaction started within 4 hours of injection and increased all night to a severe level. It was worse than when I got Covid last year. Pain in all muscles, severe headache, chills and fever, swelling in mouth, tongue, difficulty breathing, dizziness, unable to walk until noon next day, and then only with a walker. Severe nausea and vomiting, heaving. Unable to sleep all night.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Nausea and passed out 5 minutes after dosing, dizziness and Nausea 15 hours after dousing
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Chills with shaking, nausea, entire body joint aches, severe headache, fatigue, dizziness, extremith numbness.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Nausea, Tremor
Clinical narrative: Chills with shaking, nausea, entire body joint aches, severe headache, fatigue, dizziness, extremith numbness.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block complete, Blood test, Cardiac monitoring, Cardiac pacemaker insertion, Dizziness
Clinical narrative: Received injection and went home.  Was feeling  a little sluggish that evening, but I didn?t think anything about it.  The morning of January 19, 2022 at approximately  9:15 a.m., I had just left my house on foot to walk my 16 year old.  I had walked approximately 80 meters and almost immediately felt light headed and dizzy.  I immediately returned to home, took my blood pressure and my heart rate was 40.  I monitored my heart rate for approximately 45 minutes, using two separate heart rate monitors;  with only slightly different readings.  I called for my husband to come inside the house and he took me to the hospital.  Once at the hospital,  I was taken by wheelchair to an exam room where the nursing staff immediately executed a 12 lead ECG and I was diagnosed to a ?TOTAL AV BLOCK? and  was being sent to the Cardiac unit at Medical Center.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Laboratory test, Magnetic resonance imaging, Sluggishness
Clinical narrative: Received injection and went home.  Was feeling  a little sluggish that evening, but I didn?t think anything about it.  The morning of January 19, 2022 at approximately  9:15 a.m., I had just left my house on foot to walk my 16 year old.  I had walked approximately 80 meters and almost immediately felt light headed and dizzy.  I immediately returned to home, took my blood pressure and my heart rate was 40.  I monitored my heart rate for approximately 45 minutes, using two separate heart rate monitors;  with only slightly different readings.  I called for my husband to come inside the house and he took me to the hospital.  Once at the hospital,  I was taken by wheelchair to an exam room where the nursing staff immediately executed a 12 lead ECG and I was diagnosed to a ?TOTAL AV BLOCK? and  was being sent to the Cardiac unit at Medical Center.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: I began having a sensation of fullness in both ears, like a feeling of water was in my ears. It progressed to a humming and vibrating noise in my right ear and a vibrating noise in my left ear. Noises amplify the sounds more, making it worse. I am not sure if I need to go see a Dr about this or if it will resolve on it's own.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Erythema, Hypersensitivity, Induration, Injection site pain, Myalgia
Clinical narrative: I need to give a bit of history here, in order for this to make sense: Two days prior to getting vaccinated, I applied Artemisia annua tincture to a dark spot of sun damaged skin on my left bicep, and to two small, slightly raised areas of slightly rough, sun-damaged skin on my right wrist; this application was at about 10 pm on 09/21/2022.  Approximately 24 hours later, at about 10 pm on 09/22/2022, I noticed that the application site on my left bicep was slightly red, slightly itchy, and slightly raised, but this was a very mild reaction compared to some I had had previously. The tincture-treated spots on my right wrist were completely unaffected: the skin color was normal, there was no itching and no swelling. I remarked to my husband that the skin on my hands was obviously much tougher than the skin over my bicep, because I had had no allergic reaction to the tincture. NOW THE THE CRUX OF THE MATTER: Yesterday, after getting flu and  Covid omicron booster shots at about 2:45pm, the only adverse reaction I noticed during the day, was very very slight soreness in the muscle around the injection sites. But then, sometime between 9 and 10 pm, the night after the injections (Sept. 23, 2022) I realized that my right wrist was extremely itchy, and when I touched it, it felt like someone had glued builder's sand to my skin. The skin where I had applied Artemisia annua tincture, two nights previously, had broken out in very very hard, bumps that covered the skin exactly where the tincture had been applied. These bumps were so hard that they really did feel like sand. The site on my bicep, where I had applied the same tincture at the same time two nights previously, was unaffected.  This morning the bumps on my wrist were gone, and there was no itching. IN OTHER WORDS, THE VACCINATION INDUCED AN ALLERGIC REACTION IN SKIN THAT HAD BEEN EXPOSED TO AN ALLERGEN TWO DAYS PREVIOUSLY, AND HAD HAD NO REACTION UNTIL AFTER THE VACCINES WERE ADMINISTERED. AND, THE SKIN THAT HAD ALREADY HAD AN ALLERGIC REACTION TO THE ALLERGEN APPLICATION, HAD NO REACTION AFTER THE VACCINES WERE ADMINISTERED. This was obviously not a life threatening event for me, but it does seem to me to suggest that exposure to allergens BEFORE vaccination, might actually be dangerous for some people. This is why I made this report.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: I need to give a bit of history here, in order for this to make sense: Two days prior to getting vaccinated, I applied Artemisia annua tincture to a dark spot of sun damaged skin on my left bicep, and to two small, slightly raised areas of slightly rough, sun-damaged skin on my right wrist; this application was at about 10 pm on 09/21/2022.  Approximately 24 hours later, at about 10 pm on 09/22/2022, I noticed that the application site on my left bicep was slightly red, slightly itchy, and slightly raised, but this was a very mild reaction compared to some I had had previously. The tincture-treated spots on my right wrist were completely unaffected: the skin color was normal, there was no itching and no swelling. I remarked to my husband that the skin on my hands was obviously much tougher than the skin over my bicep, because I had had no allergic reaction to the tincture. NOW THE THE CRUX OF THE MATTER: Yesterday, after getting flu and  Covid omicron booster shots at about 2:45pm, the only adverse reaction I noticed during the day, was very very slight soreness in the muscle around the injection sites. But then, sometime between 9 and 10 pm, the night after the injections (Sept. 23, 2022) I realized that my right wrist was extremely itchy, and when I touched it, it felt like someone had glued builder's sand to my skin. The skin where I had applied Artemisia annua tincture, two nights previously, had broken out in very very hard, bumps that covered the skin exactly where the tincture had been applied. These bumps were so hard that they really did feel like sand. The site on my bicep, where I had applied the same tincture at the same time two nights previously, was unaffected.  This morning the bumps on my wrist were gone, and there was no itching. IN OTHER WORDS, THE VACCINATION INDUCED AN ALLERGIC REACTION IN SKIN THAT HAD BEEN EXPOSED TO AN ALLERGEN TWO DAYS PREVIOUSLY, AND HAD HAD NO REACTION UNTIL AFTER THE VACCINES WERE ADMINISTERED. AND, THE SKIN THAT HAD ALREADY HAD AN ALLERGIC REACTION TO THE ALLERGEN APPLICATION, HAD NO REACTION AFTER THE VACCINES WERE ADMINISTERED. This was obviously not a life threatening event for me, but it does seem to me to suggest that exposure to allergens BEFORE vaccination, might actually be dangerous for some people. This is why I made this report.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Patient has developed hives on arms and legs since the received the vaccination.
Age: 54.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Lymph node pain, Myalgia, Pain, Pyrexia
Clinical narrative: 100.8 fever, 18 hours  Severe body pain - all joints, muscles, lymph nodes
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cervical spinal stenosis, Fall, Fine motor skill dysfunction, Hypotension, Movement disorder
Clinical narrative: Patient had a sudden fall for the first time at 73 years old.  He acquired cervical stenosis requiring a C3-C6 posterior decompression and fusion.  He was also having severely low blood pressures requiring a levophed drip.   Patient is currently unable to move his lower extremities as well as he has no hand and finger dexterity on either hand.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Spinal fusion surgery
Clinical narrative: Patient had a sudden fall for the first time at 73 years old.  He acquired cervical stenosis requiring a C3-C6 posterior decompression and fusion.  He was also having severely low blood pressures requiring a levophed drip.   Patient is currently unable to move his lower extremities as well as he has no hand and finger dexterity on either hand.
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Bilateral thigh shingles
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: 9/23/22 Adverse Event: Vaccination Error History of moderate to severely immunocompromised client was requesting her 3rd Pfizer in the series. The Pfizer primary dose was clearly labeled with an extra label for card in a basin and was on the table, separate from booster doses which were in green covered container clearly labeled. She was given a Pfizer bivalent booster Lot GH9694 instead. The RN did not review the labeling prior to administration.  (Note the primary Pfizer was returned to me for replacement into the pharmacy area so it was unavailable for anyone else).  Treatment: we identified the mistake and staff talked with charge RN who consulted. He discussed that this was the only dose she would need for now and that she was ok. Patient was watched for 15 minutes and felt fine. She was aware of the situation and the plan. She agreed. After the client left, the nurse involved we discussed reviewing label, lot and vaccine information with scribe to confirm correct dose.  Regional Manager were also informed.  Final Plan: Dr called back after our initial discussion and agreed no repeat dose today - this finishes the series but she will need a monovalent booster in 2 months.  I will call her Saturday morning with the updated plan. Make sure puts bivalent dose as 3rd in series. (Admin) sent email to support,  RN,Site Supervisor,  and myself.  Person Reporting: Charge Nurse
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: large area swelling arm 3 weeks after injection at injection site - 3x4cm size requiring oral steroids, Ibuprofen & antihistamines for reaction
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no reaction - Pt state on screening form that she was 65. 65+ Fluad administered. Pt is actually only 64 and will be 65 on 10/7/2022
Age: 88.0
Sex: M
Vaccine: FLUA4
Symptoms: Musculoskeletal stiffness, Neck pain, Torticollis
Clinical narrative: Patient complained of neck stiffness/soreness the day after his flu vaccine, that progressively got worse. He was taken to emergency department on 09/24/22 where he was diagnosed with Torticollis. Emergency department advised this could be due to the flu vaccine, but  origin is unknown. Patient was treated with opioid and muscle relaxer, and to follow up with primary doctor if unresolved in 72 hours. Patient has significant history of leukemia.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Flu vaccine administered in left deltoid. 24 hours after injection, swelling and bruising to injection site. Swelling extended down arm towards elbow. Painful to touch and itchy. Treated with motrin and cool compresses
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Computerised tomogram thorax, Immunoglobulin therapy, Myasthenia gravis
Clinical narrative: Developed Myasthenia Gravis, currently on IVIG transfusions.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 9/23/22 Adverse Event: Vaccination Timing Error. History of Event: 6 year old male given Pfizer 5-11 years monovalent booster 2.5 months early.  Series finished 6/12/2022.  There should have been a 5-month interval.  Treatment: Mistake identified and mother aware.  Charge Nurse and Pharmacy consulted immediately. Pharmacy advised there should be no adverse effects as a result.  Client watched for 15 minutes and felt fine. Regional Manager and were also informed.  Dr advised no further Covid vaccinations for at least 5 months starting today (9/23/22) and only if CDC recommends additional boosters.   After the client left, the nurse involved we discussed door screener using chart to verify correct timing for pediatric age group vaccination timing and doublechecking throughout the process  Final Plan: Dr called back after our initial discussion and wanted us to review CDC recommendations in October to determine future vaccination schedule. Person Reporting: RN Charge Nurse
Age: 78.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Headache, Hypersomnia, Lethargy, Pain
Clinical narrative: Seven days after vaccine I started feeling very tired, achy,  headache and lethargic.  Went to bed at 5:00 pm and slept until 8:00 am the next day.  Was still tired and achy for a second day, gradually reducing feelings as the day progressed.  Third day after onset of reaction I was back to feeling normal.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Magnetic resonance imaging head abnormal
Clinical narrative: Acute CVA involving lt putamen, caudate lobe, corona radiata, and frontal cortex
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Depressed level of consciousness, Gait disturbance
Clinical narrative: Soon after the injection she went limp, blood pressure dropped and she remained semi-conscious.  We called the emergency medical team.  They did a full eval and released her to her mother to take her home.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 9/23/22, Clinic Adverse Event: Vaccination Timing Error History of Event: 10 year old male given Pfizer 5-11 years monovalent booster 2.5 months early.  Series finished 6/12/2022.  There should have been a 5-month interval.  Treatment: Mistake identified and mother aware.  Charge Nurse and Pharmacy consulted immediately. Pharmacy advised there should be no adverse effects as a result.  Client watched for 15 minutes and felt fine.   Regional Manager and Doctor were also informed.  Doctor advised no further Covid vaccinations for at least 5 months starting today (9/23/22) and only if CDC recommends additional boosters.   After the client left, the nurse involved we discussed door screener using chart to verify correct timing for pediatric age group vaccination timing and doublechecking throughout the process  Final Plan: Doctor called back after our initial discussion and wanted us to review CDC recommendations in October to determine future vaccination schedule.  Person Reporting: RN Charge Nurse
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: High dose was given instead of standard dose
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient said the first day after vaccine, injection site hurt , it was itching and swelled, and looked red. Patient said taking ibuprofen and it helps a little. She came by pharmacy and I observed that it was swollen and red and told her to take Benadryl for itching and continue ibuprofen. Second day at the pharmacy 9/24, I observed her arm to be more swollen, it is hot to the touch and she has body ache and head ache. I advised her to see a physician to get it looked at.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site warmth, Pain
Clinical narrative: Patient said the first day after vaccine, injection site hurt , it was itching and swelled, and looked red. Patient said taking ibuprofen and it helps a little. She came by pharmacy and I observed that it was swollen and red and told her to take Benadryl for itching and continue ibuprofen. Second day at the pharmacy 9/24, I observed her arm to be more swollen, it is hot to the touch and she has body ache and head ache. I advised her to see a physician to get it looked at.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: outer palm swollen
Age: 65.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Fatigue, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: Pain, swelling, and rash at injection site (Prevnar 20); aches, tiredness, 101° fever (influenza shot)
Age: 65.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Pyrexia
Clinical narrative: Pain, swelling, and rash at injection site (Prevnar 20); aches, tiredness, 101° fever (influenza shot)
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Feeling abnormal
Clinical narrative: fatigue, chills and a general foggy state of mind, which lasted 24 hours
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient wanted Flu Shot and received Pfizer bivalent booster instead. Patient has never received any type of Covid-19 vaccine in the past. Post 24 hours and patient has had no reaction thus far., was advised to fill out form in case
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: PT HAD SEVERE PAIN IN ARM
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: After receiving the vaccine, the client passed out briefly while in the vaccinators chair, he came back in about 30 seconds, wife was with him and gave him some sugar pills she had. Client had not eaten breakfast, but had been drinking water. Wife stated client was a diabetic and had not eaten breakfast. Client never mentioned diabetes to vaccinator, only told her he had high blood pressure only. Client remained in my seat for about 15 minutes, when he stood up, he had urinated in his pants. He waited another 15 more minutes and advised to eat something and continues drinking water.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Impaired work ability, Magnetic resonance imaging head abnormal, Neuritis cranial
Clinical narrative: I was diagnosed with Bell's Palsy and have had severe and persistent symptoms to the point that I can no longer do my full time job as a teacher. I am now forced to apply for disability retirement after teacher for 24 years.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Rash, Urticaria
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Swelling of upper left arm with hives present.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild
Age: 72.0
Sex: F
Vaccine: UNK, COVID19-2
Symptoms: Chest X-ray normal, Fibrin D dimer normal, Pericarditis
Clinical narrative: clinical pericarditis following bivalent covid19 vaccine lasting 3 days.
Age: 72.0
Sex: F
Vaccine: UNK, COVID19-2
Symptoms: Pericarditis
Clinical narrative: clinical pericarditis following bivalent covid19 vaccine lasting 3 days.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fall
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: Due to weakness, pt. has fallen several times.
Age: 24.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Headache, Impaired work ability, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: I did not have any adverse side effects in the short term after taking these vaccines (short term here is from the time of the shots which was 9/11/2022 to about 3-4 days later). However, starting 9/19/2022, I started experiencing a moderate to severe headaches. They would come in waves and were sometimes quite debilitating. I would have to stop working and lie down quite often. I tested negative for COVID (PCR at drive through) and the flu, so I chalked it up to the vaccine. The symptoms only very recently resolved, on 9/23/2022, and still feeling a bit of fatigue (though this might be unrelated). This was adverse for me because never have I had side effects nearly two weeks after a COVID vaccine let alone any sort of vaccine.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash all over body. Not itchy. Small red bumps
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Tremor
Clinical narrative: herpes reaction spt  4 getting severe by spt 10.  tool valcyclovir 4 days.  second reaction spt 22 with tremors
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: On day of vaccine (9/22/22), patient called back at approximately 5:22pm stating that her arm was swollen and itchy.  She was advised to ice the area, and take some Tylenol and Benadryl.  She was also advised that if the reaction continued she should by seen by a physician.  Her husband informed us on 9/24/22 that she was admitted into the hospital. He said they marked the area with a marker and that swelling continued beyond the marked area.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Influenza virus test, Mechanical urticaria, Pruritus, SARS-CoV-2 test
Clinical narrative: Started experiencing Hives 2-3 weeks post vaccination.  The hives come with skin irritation (i.e. scratching, brushing, scraping). They were all over my body and are still occurring. I'm also experiencing Dermatographia. I have chronic pruritus (itchiness) with the hives.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Scratch, Skin irritation, Urticaria
Clinical narrative: Started experiencing Hives 2-3 weeks post vaccination.  The hives come with skin irritation (i.e. scratching, brushing, scraping). They were all over my body and are still occurring. I'm also experiencing Dermatographia. I have chronic pruritus (itchiness) with the hives.
Age: 14.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient received two vaccines on the left arm as requested by the patient while patient's mom is next to her at 11am.  patient started feeling nauseated and feeling faint but didn't end up fainting but threw up in the garbage can. mom reported to intern that patient often vomits after all vaccinations and is fine after 15 minutes of resting. Mom and patient said it is not necessary to call their doctor or go to call paramedics. They both walked out fine after 30 minutes
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: patient wanted moderna bivalent booster and received moderna monovalent instead
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: Hives began on 9/18/22 and continue to spread across my torso and buttocks, with smaller rash on arms and legs
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Urticaria
Clinical narrative: Hives began on 9/18/22 and continue to spread across my torso and buttocks, with smaller rash on arms and legs
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Injection site induration
Clinical narrative: Swelling/Hard bump at injection site lasting more than 3 days that is warm to the touch, swelling of lymph nodes in left armpit, fatigue, joint pain, muscle aches, fevers, chills, difficulty breathing
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Swelling/Hard bump at injection site lasting more than 3 days that is warm to the touch, swelling of lymph nodes in left armpit, fatigue, joint pain, muscle aches, fevers, chills, difficulty breathing
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Chills, Feeling of body temperature change, Pyrexia, Tremor
Clinical narrative: Had vaccine at 3:15 pm and around 3 am following day was violently shaking for almost 30 minutes due to chills and being cold. Couldn't speak  and only could nod. Breathing was ok 99 fever.  Managed to get her to drink 1/2 liter of water and Tylenol. Shaking subsided ONLY after using a heating pad on high for 15 minutes to get her to warm up. Then about 45 minutes later she was better and felt hot! Very scary experience.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: chills, fatigue, muscle aches, joint aches, sore arm
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent booster given when bivalent booster recommended,
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine given when bivalent recommended
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was administered ~20 hours after drawn into syringe
Age: 25.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after receiving vaccine patient was diaphoretic and experienced syncopal episode. Regained consciousness after 10 seconds. symptoms resolved.
Age: 17.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: After receiving the vaccines at 2:30pm 9/24/2022, the patient stood up from the chair, in which then he experienced syncope and fainted and fell to the ground. Patient regained consciousness within seconds, and sat on a chair and was observed by the pharmacist for half hour after the incident. Patient did not experience any further lightheaded or any pain anywhere from the fall. Patient did not hit his head. After half hour patient was driven home by his mother. Pharmacist followed up with the patient at 4pm. Mother stated patient was doing fine and has not experienced any other issues.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pallor, Syncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Pt was seated upright on chair next to a shelf located on his left hand-side. I first administered flumist intranasally. Has hx of Flumist without any problems. He tolerated today's dose well without any issues. Next I administered Pfizer Bivalent Booster 0.3 mL IM to his L deltoid. After administration and applying a band aid I gave him his updated vaccination card and walked back to the pharmacy counter. ~1 minute after, we heard a thud. When I turned around, pt was slumped over on left side on shelf, still seated on chair. Other pharmacist rushed over to hold him up as I called 911. He appeared to be pale and unresponsive for about 10 seconds or so. He eventually came to after a few attempts of trying to wake him up. He appeared to be back to his normal self, alert and oriented however he could not recall what had happened and thought perhaps he "just closed [his] eyes and fell asleep". He also appeared to have urinated on himself during the event. We escorted to a room in the back that was cooler and away from windows. We also gave him some water to drink. Paramedics appeared shortly after to assess the patient. Upon questioning from the paramedics, pt reported he felt a little hot before vaccination was given (he was seated next to window, it was sunny outside, outside temp in 90s, front of pharmacy is typically warmer than the rest of the pharmacy). He also reported only eating a banana that morning. Per paramedics, pt's vital signs were normal. Pt did not want to go with paramedics to hospital for further evaluation and reported he felt okay to go home. He reported his father is a doctor and would consult with him if he had any further concerns.
Age: 53.0
Sex: F
Vaccine: FLUR4, HEP, HEPA, PNC20
Symptoms: Ocular discomfort, Rash
Clinical narrative: Rash on left sholder, went away after a day - rash on left thigh, getting better - pressure in left eye (history of symptoms without vaccine previously)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site swelling, Joint stiffness, Nasal congestion
Clinical narrative: Body aches, stuffy nose, fever, exhaustion, headache, swelling at site, joint stiffness.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Body aches, stuffy nose, fever, exhaustion, headache, swelling at site, joint stiffness.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Vomiting
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Child passed out after the vaccine administration ( he stood up and watched sister being vaccinated)
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Liver disorder, Muscle spasms, Nasopharyngitis, Nausea, Pain
Clinical narrative: Nausea cold liver spasms body aches
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Per patient she received the shot on Wednesday 9/21/22 in her right arm. Didn't take a look at it until the next morning and noticed and injection site reaction. Arm was red and swollen about 2 1/2". Reported to pharmacist on duty on Thursday. Let the vaccine administrator know Friday night. Tried to follow up and left voicemail. Patient called back Saturday afternoon. Reported that redness/warmth has spread to about 7". Pt took aleve the night of and then an antihistamine Thursday. Tried cold compress as well. Recommended to follow up with a doctor to be safe, continue with anti-inflammatory and cold compresses.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Depersonalisation/derealisation disorder, Dry mouth, Dysphagia, Erythema, Flushing
Clinical narrative: Pt. received Bivalent Pfizer @1030, during patients 30 min observation pt.  reported experiencing palpitations, tingling around mouth, swelling /dry mouth, some difficulty swallowing, blurry vision, not feeling like herself and some flushing "redness" on face.  EMS activated @10:56 upon assessment.  AXOx4, airway intact, no visible urticaria. VS competed Q4mins as follows 10:54-HR:115 BP:182/94 Spo2:100  10:56-HR:109 BP:180/95 SPo2:100 11:00-HR:104 BP:178/92 SPo2:100 11:04-HR: 107 BP:185/93 Spo2:100 EMS arrived at approximately 1105, pt. evaluated by EMS and facility physician transported to ED for further evaluation.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Mouth swelling, Palpitations, Paraesthesia oral, Vision blurred
Clinical narrative: Pt. received Bivalent Pfizer @1030, during patients 30 min observation pt.  reported experiencing palpitations, tingling around mouth, swelling /dry mouth, some difficulty swallowing, blurry vision, not feeling like herself and some flushing "redness" on face.  EMS activated @10:56 upon assessment.  AXOx4, airway intact, no visible urticaria. VS competed Q4mins as follows 10:54-HR:115 BP:182/94 Spo2:100  10:56-HR:109 BP:180/95 SPo2:100 11:00-HR:104 BP:178/92 SPo2:100 11:04-HR: 107 BP:185/93 Spo2:100 EMS arrived at approximately 1105, pt. evaluated by EMS and facility physician transported to ED for further evaluation.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Urinary incontinence
Clinical narrative: she became dizzy after witnessing her brother " pass" out after his shot . She layed on the ground and urinated on herself
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Pt. fainted walking out of the office. Then again as we tried to get her to a seat.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Movement disorder
Clinical narrative: Pt complained of extreme pain at the site of injection.  Unable to move his arm.  He had to go to the emergency room for the pain.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child was administered the pediatric Pfizer vaccine for age 5-11. Child was presumed over age 5 due to being large for his age. When logging the vaccine into the computer it was realized the child was 5 days short of his 5th birthday.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Back pain, Chest pain, Dyspnoea, Fatigue
Clinical narrative: "MODERNA COVID-19 VACCINE, BIVALENT EUA". It has been about 10 days and I still feel the effects of extreme fatigue. Starting from the beginning: (I received both the Influenza and the COVID shot; I don't have any paperwork with me identifying which Flu shot I received. So, I could not list it above in Item 17), so, the day I got the shots, I was fine, I didn't feel any symptoms. However, the next day I felt terrible with flu like symptoms (aching all over and back pain, etc.) this has been normal with all the COVID-19 shots but by the second day I would be completely fine. However, in this case, from the third day to maybe the 5th day, I had difficulty breathing, I was out of breath just barely doing anything, some chest pain and no energy and extreme fatigue, I just didn't feel good. Now it is just extreme fatigue and no energy.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Influenza like illness, Pain
Clinical narrative: "MODERNA COVID-19 VACCINE, BIVALENT EUA". It has been about 10 days and I still feel the effects of extreme fatigue. Starting from the beginning: (I received both the Influenza and the COVID shot; I don't have any paperwork with me identifying which Flu shot I received. So, I could not list it above in Item 17), so, the day I got the shots, I was fine, I didn't feel any symptoms. However, the next day I felt terrible with flu like symptoms (aching all over and back pain, etc.) this has been normal with all the COVID-19 shots but by the second day I would be completely fine. However, in this case, from the third day to maybe the 5th day, I had difficulty breathing, I was out of breath just barely doing anything, some chest pain and no energy and extreme fatigue, I just didn't feel good. Now it is just extreme fatigue and no energy.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Condition aggravated, Crohn's disease, Fatigue, Lymph node pain
Clinical narrative: Not sure if it is related but wanted to report in case there is a trend  moving forward so that the research can be accurate.  I have crohns which has been in remission for years.  A week after the bivalent vaccine I am in a crohns flare up.  The night of the shot I had expected side effects including sore arm, pain in lymph node under arm, aches and pains, fever, chills, fatigue. This lasted through the night and into the next day then resolved.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Not sure if it is related but wanted to report in case there is a trend  moving forward so that the research can be accurate.  I have crohns which has been in remission for years.  A week after the bivalent vaccine I am in a crohns flare up.  The night of the shot I had expected side effects including sore arm, pain in lymph node under arm, aches and pains, fever, chills, fatigue. This lasted through the night and into the next day then resolved.
Age: 86.0
Sex: M
Vaccine: FLUA4
Symptoms: Back injury, Back pain, Chest pain, Gastrointestinal disorder, Heart rate increased
Clinical narrative: Pt has no previous history of Hypertension, Hyperchlorolemia, Chest pain, and IMZ adverse reaction. This pt received FLUAD this morning. Within 15 minutes of flu shot, pt expressed severe chest pain, lower back pain. His BP was 186/95 HR 85. He was in panic and worried about his symptoms might be related with flu shots. We called 911. However, after I gave him 5ml of Benadryl oral solution, 81mg of aspirin chew tablet, 650mg of Tylenol ER, pt stated he felt much better and requested us to cancel 911 which we did. I checked his BP again15 min later, it went down to 182/100 HR 82 but still very high. I consulted with Dr. on pt's symptoms. Dr. advised me to give 1 tablet of NTG0.4mg sub lingual tablet with 30 min observation. I went over possible side effects of NGT and asked pt if he would like to take it. Pt agreed to take it. 30 min after I gave 1 dose of NTG 0.4mg Sub tablet, I re-checked his bp. BP went down to 154/83 HR 85. After his symptoms completely resolved, pt stated that he injured his lower back last night and he has been having stomach problem so he has been self medicated with Tums at home. But he doesn't know why he got the sudden pains. He stayed another 30 min in the store and left with lingering no symptoms.
Age: 86.0
Sex: M
Vaccine: FLUA4
Symptoms: Panic reaction
Clinical narrative: Pt has no previous history of Hypertension, Hyperchlorolemia, Chest pain, and IMZ adverse reaction. This pt received FLUAD this morning. Within 15 minutes of flu shot, pt expressed severe chest pain, lower back pain. His BP was 186/95 HR 85. He was in panic and worried about his symptoms might be related with flu shots. We called 911. However, after I gave him 5ml of Benadryl oral solution, 81mg of aspirin chew tablet, 650mg of Tylenol ER, pt stated he felt much better and requested us to cancel 911 which we did. I checked his BP again15 min later, it went down to 182/100 HR 82 but still very high. I consulted with Dr. on pt's symptoms. Dr. advised me to give 1 tablet of NTG0.4mg sub lingual tablet with 30 min observation. I went over possible side effects of NGT and asked pt if he would like to take it. Pt agreed to take it. 30 min after I gave 1 dose of NTG 0.4mg Sub tablet, I re-checked his bp. BP went down to 154/83 HR 85. After his symptoms completely resolved, pt stated that he injured his lower back last night and he has been having stomach problem so he has been self medicated with Tums at home. But he doesn't know why he got the sudden pains. He stayed another 30 min in the store and left with lingering no symptoms.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered original Pfizer Covid-19 vaccine instead of bivalent Pfizer  Covid-19 vaccine
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient received the Covid vaccine in Left arm. Asked for a minute, then passed out and started seizing
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Bedridden, Chills, Contusion, Decreased appetite
Clinical narrative: Fever, Aches all over body, chills, fatigue, back muscle pain, loss of appetite, 2 1/2 days bedridden. Very much similar to flu symptoms.  Left arms swollen, deeply bruised 2 inches in diameter, painful to touch.  5 days couldn't lay on that arm.  8 days still feel injection area with mild discomfort.