chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Cardiac monitoring, Heart rate increased
Clinical narrative: fast heartbeat within 4 and 5 weeks after administration of menactra; Initial information received on 06-Oct-2022 regarding an unsolicited non-valid serious case received from other health professional.  This case is linked to case 2022SA413588.  This case involves Adolescent female patient who experienced fast heartbeat within 4 and 5 weeks after administration of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (dose, strength, formulation, and lot number: unknown, expiry date: 22-Apr-2023) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency: approximately after 4-5 weeks), the patient developed a serious event of fast heartbeat within 4 and 5 weeks after administration of menactra (heart rate increased).  Nurse says that she considered the incident to be serious because she had to call 911.  Feels this was a serious event since her daughter is still experiencing rapid heart rate and sees a pediatric cardiologist and had her heart monitored for 14 days. She wants it noted the event didn't happen while she was receiving the vaccine.   Action taken : not applicable  It was not reported if the patient received a corrective treatment for the event.   Outcome: Not recovered/not resolved  Seriousness criteria: medically significant.    Additional information was received on 25-Oct-2022 from other health professional: Patient gender and age group was added and case was upgraded to valid case, event seriousness was updated to serious and narrative was amended accordingly.; Sender's Comments: Sanofi Company Comment dated 01-Nov-2022: This case involves Adolescent female patient who experienced fast heartbeat within 4 and 5 weeks after administration of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. However, the patient's vaccination history, medical history, tolerance, concomitant medications, allergic history and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed individually assessed.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Sore arm where the shot was given; This spontaneous case was retrieved on 19-Oct-2022 from non-health care professional via Agency (reference number: SEQW22-04712) and concerned a 71-year-old female patient.   The patient's medical history and concomitant medications were not reported.   On 18-Oct-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On the same day following vaccination, patient developed sore arm where the shot was given.   At the time of initial reporting, patient reported that arm was sore at night ands still is.  The outcome of event was not recovered.  The reporter assessed event as related to influenza vaccine. As reported, patient have been getting flu shots for over thirty years and never had any reaction other than a sore arm where the shot was given.   The case was assessed as non-serious.  This case is linked with case 202205916 (the same reporter and patient).  Company comment: A 71-year-old female patient was vaccinated with influenza vaccine. On the same day following vaccination, patient experienced sore arm where the shot was given. Causal role of the suspect vaccine is assessed as possibly related, due to suggestive temporal relationship and biological plausibility.; Reporter's Comments: Patient have been getting flu shots for over thirty years and never had any reaction other than a sore arm where the shot was given.; Sender's Comments: A 71-year-old female patient was vaccinated with influenza vaccine. On the same day following vaccination, patient experienced sore arm where the shot was given. Causal role of the suspect vaccine is assessed as possibly related, due to suggestive temporal relationship and biological plausibility.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: A little soreness in the arm; This spontaneous case  was received on 26-Oct-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-05093) and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.  On unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; route of administration, anatomical location, and dose: not reported) as vaccination against influenza. The batch number was not reported.  On unspecified date, an hour after receiving influenza vaccine, the patient experienced a little soreness in the arm.  The outcome of the event was unknown.  The reporter assessed the event to be related to influenza vaccine. As reported, the patient never before had a reaction to a flu shot, apart from little soreness in the arm.   The case was assessed as non-serious.  This case is linked to case 202206466 (the same patient/reporter).  Company comment: A female patient of unreported age was vaccinated with the suspect product influenza vaccine. Within one hour after vaccination the patient developed pain in arm. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: As reported, the patient never before had a reaction to a flu shot, apart from little soreness in the arm.; Sender's Comments: A female patient of unreported age was vaccinated with the suspect product influenza vaccine. Within one hour after vaccination the patient developed pain in arm. Based on plausible time relationship, causality is assessed as possibly related.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: admister monovalent instead of bivalent
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: admister monovalent instead of bivalent
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: admister monovalent instead of bivalent
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: admister monovalent instead of bivalent
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: admister monovalent instead of bivalent
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: administer monovalent instead of bivalent
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: admisnter monovalent instead of bivalent
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: administer monovalent instead of bivalebt
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Hypoaesthesia, Movement disorder, Paraesthesia
Clinical narrative: Facial numbness/challenge to move  (Bells Palsey) and Tingling in left arm
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Product administered at inappropriate site
Clinical narrative: Vaccinating RN administered vaccine superior to deltoid muscle target area, observed by FNP on duty to be near joint.  An immediate red, indurated area appeared, approx. 30mm in diameter.   Recipient denied pain, discomfort and had no impact on range of motion.  Patient was observed for 30 minutes, reassessed and provided precautionary guidance by FNP on duty prior to leaving the clinic.  No other clinical manifestations presented during observation period.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort, Pain
Clinical narrative: The injection itself was quite painful, my arm was sore after the injection but became very uncomfortable by bedtime. Today  the pain is more substantial, raising and lowering my arm is difficult.  This is the first vaccine that has been really painfu during and after.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Appetite disorder, Discomfort, Dysgeusia, Headache, Injection site warmth
Clinical narrative: About two days after I became very sore in my throat but it began to go away around the evening of day 3.  Now today on the 5th of November I woke up from an excruciating headache to the point I thought maybe I was having a mini stroke at first.  Since then my glands in my neck have swollen up, there is pressure between the space between the nose and throat in the back, my breathing is heavy, fevers continue, sore throat, post nasal drip, feel warm in my mouth and at injection site still.  Noticed an uncharacteristic change appetite the day after injection with a consistent metallic taste that hasn't gone away since.  Swelling up of feet more than normal and same with legs.  Still going through so outcome not yet known at this time.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Lymphadenopathy, Oral discomfort, Oropharyngeal pain, Peripheral swelling, Pyrexia
Clinical narrative: About two days after I became very sore in my throat but it began to go away around the evening of day 3.  Now today on the 5th of November I woke up from an excruciating headache to the point I thought maybe I was having a mini stroke at first.  Since then my glands in my neck have swollen up, there is pressure between the space between the nose and throat in the back, my breathing is heavy, fevers continue, sore throat, post nasal drip, feel warm in my mouth and at injection site still.  Noticed an uncharacteristic change appetite the day after injection with a consistent metallic taste that hasn't gone away since.  Swelling up of feet more than normal and same with legs.  Still going through so outcome not yet known at this time.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Respiration abnormal, SARS-CoV-2 test negative, Upper-airway cough syndrome
Clinical narrative: About two days after I became very sore in my throat but it began to go away around the evening of day 3.  Now today on the 5th of November I woke up from an excruciating headache to the point I thought maybe I was having a mini stroke at first.  Since then my glands in my neck have swollen up, there is pressure between the space between the nose and throat in the back, my breathing is heavy, fevers continue, sore throat, post nasal drip, feel warm in my mouth and at injection site still.  Noticed an uncharacteristic change appetite the day after injection with a consistent metallic taste that hasn't gone away since.  Swelling up of feet more than normal and same with legs.  Still going through so outcome not yet known at this time.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hypersensitivity
Clinical narrative: Chills, fatigue, hypersensitivity of sensory system
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Diarrhoea, Electrocardiogram, Headache
Clinical narrative: High blood pressure 160/100, headache, diarrhea, weakness, painful swollen glands, chest discomfort
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Hypertension, Lymph node pain, Lymphadenopathy
Clinical narrative: High blood pressure 160/100, headache, diarrhea, weakness, painful swollen glands, chest discomfort
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: patient was alert, felt dizzy and was sitting on floor when ambulance arrived-Mild, Additional Details: Patient reported no nervousness when taking the flu vaccine and said she has taken flu vaccines before. She reported no allergies. Patient felt dizzy, was alert and sitting on the floor in the cosmetic isle when ambulance arrived. When they arrived, they report normal vital signs and helped her walk out to her car.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: mild rash on shoulder, upper back, and chest. and pt took benadryl herself-Medium, Additional Details: Rash developed after one hour recevived vaccine and took Benadryl and apply hydrocortisone topicall herself. itch and rash getting better but not resolved even till today. pt called md but md did not answer her call today.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Erythema, Flushing, Hyperhidrosis, Injection site erythema
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: PT COMPLAINS OF GENERAL BODY ACHES, PAIN AND SWELLING IN JOINTS, REDNESS ALL OVER BODY-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling, Joint swelling, Lymphadenopathy, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: PT COMPLAINS OF GENERAL BODY ACHES, PAIN AND SWELLING IN JOINTS, REDNESS ALL OVER BODY-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted after receiving Pfizer Bivalent + Flucelvax in opposite arms, pt recovered after approx 15 seconds, paramedics brought her to hospital where she fully recovered after about 3 hrs per pt follow-up interview
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Chest discomfort, Chest pain, Chills, Fatigue
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient is experiencing pain in back as well as injection site. Patient asked location of site. Patient pointed to area on left arm (4 fingers from shoulder within guidelines)
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Foreign body, Needle issue
Clinical narrative: Error: Foreign Body (Needle Tip) left in patient-
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Extrasystoles
Clinical narrative: I have had a heart flutter since receiving the vaccine.   It sometimes takes my breath away.  It is flutter feeling which almost feels like my heart is skipping a beat.  Have never experienced anything like this before.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: I administered the monovalent vaccine instead of the bivalent booster
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left arm shoulder to elbow, consulted physician, Cephalexin 500mg  QID prescribed (7 days)
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Unevaluable event
Clinical narrative: One
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was receiving vaccine and fainted immediately after needlestick.  Was lowered to the floor. Unconscious for approx. 10 seconds. regained consciousness, was alert and oriented within minutes of event. Vitals monitored, juice given, recovered in chair under observation.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Feeling abnormal, Feeling hot, Muscular weakness, Presyncope
Clinical narrative: 15 minutes after the injection I felt hit all over, even my eyeballs. I was weak and needed to sit down due to feeling pre-syncopal. After 5-10 minutes the feeling of hot went away. I still felt weak but not pre-syncopal. During the day I had to sit every 10-15 minutes due to my legs feels like they were going to buckle. This lasted for the entire day. The next day I felt better but it took 3 days to feel normal.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was due for second primary dose of Covid-19 vaccine and received the bivalent.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: Woke up with a very swollen arm, arm is firm, and red from the shoulder to the elbow. And very hot. Also experiencing itching.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient received vaccine , waited about 5 minutes and then passed out for about 5 seconds. She did not fall on the floor nor hit her head. She reported no adverse reaction  from any previous vaccines but she reported she hadn't eaten all morning and she had a fear of needles
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Lower respiratory tract congestion, Nasal congestion, Oropharyngeal pain
Clinical narrative: Fatigue, sore throat, bronchial and nasal congestion, headache.  Nasal congestion continuing more than 2 weeks.
Age: 12.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Urticaria
Clinical narrative: Patient started with extensive hives exactly one week after receiving the Pfizer bivalent booster and flu shot at a local pharmacy.  Initially seen by our office on 10/27/2022 and put on zyrtec 10mg BID and benadryl 12.5mg Qhs.  Seen at our office again with continued hives on 11/4/22 and put on a 5 day pred pack - 40mg QD x 5 days.  This is when we found out she had her flu shot and COVID Pfizer booster shot at a pharmacy exactly a week prior to this hive reaction starting.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was due for second primary dose of Covid-19 and received bivalent.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure decreased, Body temperature increased, Cough, Headache
Clinical narrative: All of these occurred the 1st day after vaccination:  1) Soreness at injection site 2) Increased resting pulse rate (90 instead of 60) 3) Muscle aches and feeling weak 4) Slightly elevated temperature 5) Slight headache 6) Slightly reduced blood pressure 7) Clogged nose and some coughing
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site pain, Myalgia, Nasal congestion
Clinical narrative: All of these occurred the 1st day after vaccination:  1) Soreness at injection site 2) Increased resting pulse rate (90 instead of 60) 3) Muscle aches and feeling weak 4) Slightly elevated temperature 5) Slight headache 6) Slightly reduced blood pressure 7) Clogged nose and some coughing
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Blood test, Electrocardiogram, Extrasystoles, Heart rate irregular
Clinical narrative: Diagnosed with irregular heart beat on November 2, 2022 when attempting to donate blood at a Blood Drive. Unable to donate due to skipped heart beats exceeding guidelines. No previous indications.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Heart rate irregular
Clinical narrative: Diagnosed with irregular heart beat on November 2, 2022 when attempting to donate blood at a Blood Drive. Unable to donate due to skipped heart beats exceeding guidelines. No previous indications.
Age: 11.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 11 years old but the 12+ year old Pfizer Bivalent Booster was administered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Faecal calprotectin normal
Clinical narrative: My health changed after the covid vaccine. Before the vaccine I had very healthy stool (always level 4 on Bristol scale) and i haven?t had a solid stool since receiving the vaccine in March 2021. It?s level 6 or 7 on Bristol scale everyday since the vaccine. Of course I can?t know for sure what the cause is but there haven?t been any changes to my lifestyle or eating habits.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Herpes zoster, Laboratory test, Rash pruritic
Clinical narrative: Developed an itchy rash around the back of my head and neck.  Thought it was a spider bite, but went to urgent care and the doctor thinks it ?Shingles?.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Electrocardiogram normal
Clinical narrative: Experienced chest pain when breathing. The deeper the breath the deeper the pain
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Patient has not been able to move arm past shoulder height. Patient had rotator cuff procedure in 1997 but doesn't believe that it is related to the pain since she has gotten the vaccine for at least the past 3 years. The patient will schedule an appointment with specialist to further evaluate the cause of the arm soreness and limited mobility since the vaccination. Patient also reports tingling sensation in her fingers ever since the vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Dysarthria, Dysphagia, Gait disturbance, Hyperactive pharyngeal reflex
Clinical narrative: Woke up with mild slurred speech on Nov 7. Progressed to dysphasia, difficulty mobilizing secretions, difficulty chewing and swallowing, difficulty walking, and  hypersensitive gag.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mastication disorder, Sputum retention
Clinical narrative: Woke up with mild slurred speech on Nov 7. Progressed to dysphasia, difficulty mobilizing secretions, difficulty chewing and swallowing, difficulty walking, and  hypersensitive gag.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein increased, Colonoscopy abnormal, Computerised tomogram abnormal, Constipation
Clinical narrative: Diverticulitis onset (pain, fever). Constipation) It Was treated outpatient with 4 antibiotics. Symptoms continued for several months .. This episode followed  by 2 more episodes during 1 year.  Same symptoms , treated with antibiotics.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Inflammatory bowel disease, Magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: Diverticulitis onset (pain, fever). Constipation) It Was treated outpatient with 4 antibiotics. Symptoms continued for several months .. This episode followed  by 2 more episodes during 1 year.  Same symptoms , treated with antibiotics.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Cutaneous vasculitis, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Fever 101.5, shaking, developed cutaneous Leukocytoclastic Vasculitis (feet, legs, abdomen, upper arms). Hands and feet all became swollen.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Headache, Pulmonary congestion
Clinical narrative: Patient woke up the morning after vaccine with a severe headache and cough. 5 days later still feeling a lot of chest congestion. She did report that she had been on an airplane 7 days prior so it is possible she got sick from that and it was a coincidence.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient Did not present to nurse with proof of vaccination. Self-attested to native language speaking nurse and certified translator that she had only had one dose of COVID-19 vaccine. Because primary dose was to be documented on a form, when we logged into the state vaccine registry, we discovered that she had had 3 monovalent Pfizer shots with the last one being recorded on 09/28/2022. She was not yet eligible to receive the bivalent booster, and received a 4th monovalent dose.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Fainting and self- urination. Symptoms Resolved at home and did not seek medical treatment
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Started lightheaded feeling a few hours after I got vaccine. Got worse that evening and woke next morning quite dizzy. Worst of it wore off in a couple hours but still slightly unbalanced.  On Sunday, 10/16/22, woke up very dizzy and almost fell back on the bed. Since then no more bad dizzy spells but I never feel right except for 2 or 3 intermittent days (one being yesterday, 11/4/22) where I?ve felt normal. Every other day I feel slightly woozy and also  mildly nauseated.  It has now been 3 1/2 weeks since my shot.  My doctor didn?t think it was the vaccine but I do. I?ve never felt like this before and it started just a few hours after the shot.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Cold sweat, Dizziness, Pallor, Supine position
Clinical narrative: Pt received his 2nd dose of Monkey pox vaccine on his Rt forearm, Pt started complaining of dizziness 5mins after, Pt was laid flat supine on the floor, he drank some water and verbalized that he felt better, he was clammy, pale, denies being diabetic but he stated that he has hx of hypertension, initially 02 sat was 92% on RA, pulse 58, BP 165/80, Temp 97.9-Pt stated that he has not taken his BP meds today. After about 10mins of observation with Pt still lying down, 02 sat 98% on RA, pulse 78, no change in BP. Skilled nurse instructed patient to take his BP meds as soon as possible-he verbalized understanding. He was monitored for 30mins after the incident and he stated that he was fine and able to go home. He came with a friend so he was not alone.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was giving pfizer 2-11 year olds instead of the Adult pfizer 12+
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Chills, low grade temp (99.3) red swollen arm. Lasted for 3-4 hours then symptoms stopped. The red swelling lasted several more days
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 67.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna 6mo-5y
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Costochondritis, Echocardiogram, Electrocardiogram
Clinical narrative: Developed mild myocarditis, milf pericarditis, and costochondritis, took steroids
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Developed mild myocarditis, milf pericarditis, and costochondritis, took steroids
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Pyrexia, Screaming, Sleep disorder, Sleep terror
Clinical narrative: At midnight Pt woke up screaming in bed hallucinating.  She proceeded to hallucinate all night long in sheer terror that snakes were biting her.  She had a fever of 103 so we treated it with Motrin but that didn?t take it fully down so three hours later we gave Tylenol.  Her fever finally resolved with the Tylenol but the hallucinations continued all night and into the morning.  She had a low grade fever again after all the meds wore off and continued to talk about biting on her feet.  Finally into late morning after another dose of Motrin, she seemed to perk up more and hasn?t talked about snakes since.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient stated she wanted to receive her first COVID vaccine. This was missed by the pharmacist on duty and the vaccine was processed as a second booster. Patient was administered Bivalent Pfizer dose as her first dose when she had never received any COVID vaccine prior to the event.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Incorrect product formulation administered
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported. Just feeling tired, headache, and no appetite for 2 days.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient went to the doctor to get treatment after recommendation from me the pharmacist.  Patient complained of severely swollen arm the is red, sore and hot to the touch.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 5 year minimum intervals between first PPSV23 and 2nd PPSV23 not met
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Lymphadenopathy, Myalgia
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster.  Tender muscle, visible lymph node is swollen under armpit.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic spontaneous urticaria, Pruritus, Sleep disorder, Urticaria
Clinical narrative: -I got the booster on 9/11 - Started having symptoms overnight on 9/23. I was woken up by intensely itchy feet and hands -On 9/26 I started getting hives as well -Every evening around 8 or 9 pm I get hives and get super itchy, my feet start to itch too -The symptoms are worse at night and are still waking me up in the night if I don't take antihistamines -Dr. diagnosed this as chronic spontaneous urticaria
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: During a community vaccine clinic,  a Registered Nurse forgot to add diluent prior to administering the vaccine in the patient's right arm.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: mild dizziness, nausea, vertigo-like symptoms
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: At a community Flu/COVID event, a registered nurse inadvertently administered the Pfizer COVID Bivalent vaccine without the diluent.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discharge, Erythema, Inflammation, Pain, Papule
Clinical narrative: Delayed symptoms, not at  injection site. After approx 4-5 weeks, rash presenting at first as itchy papules in right elbow crease, erupting into painful red wheals over initial 2 wks. Left arm elbow crease red papules then appeared, itchy; also spreading into wheals; this then developed over forearm area. Skin color of right elbow crease  remains red with slight raised appearance, but right arm area pruritis diminishing. Left elbow crease and now forearm area worsened, eventually with large persistent itchy wheals, including from point of elbow to about 4? from wrist. Pressure or scratching leaves graphic trace wheals. As of Nov. 5 left forearm still marked with several  flatter red wheals, now mildly itchy, approx 2 to 2.5? diameter. Both arms initially had point-of-elbow involvement. Pruritis over forearm and elbow crease seemed to increase at end of day during initial period. Topical cortisone cream seemed to allay pain and itchiness. Neosporin applied to areas with broken skin from scratching; gauze bandaging overnight especially over highly inflamed left forearm. No pus nor red lines occured, mostly saw clear serum-like exudate. This spontaneous urticarial issue is novel to me. Lasting from approx August 17, 2022 to November 5, 2022 (present day) but is now diminishing in intensity.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Scratch, Skin swelling
Clinical narrative: Delayed symptoms, not at  injection site. After approx 4-5 weeks, rash presenting at first as itchy papules in right elbow crease, erupting into painful red wheals over initial 2 wks. Left arm elbow crease red papules then appeared, itchy; also spreading into wheals; this then developed over forearm area. Skin color of right elbow crease  remains red with slight raised appearance, but right arm area pruritis diminishing. Left elbow crease and now forearm area worsened, eventually with large persistent itchy wheals, including from point of elbow to about 4? from wrist. Pressure or scratching leaves graphic trace wheals. As of Nov. 5 left forearm still marked with several  flatter red wheals, now mildly itchy, approx 2 to 2.5? diameter. Both arms initially had point-of-elbow involvement. Pruritis over forearm and elbow crease seemed to increase at end of day during initial period. Topical cortisone cream seemed to allay pain and itchiness. Neosporin applied to areas with broken skin from scratching; gauze bandaging overnight especially over highly inflamed left forearm. No pus nor red lines occured, mostly saw clear serum-like exudate. This spontaneous urticarial issue is novel to me. Lasting from approx August 17, 2022 to November 5, 2022 (present day) but is now diminishing in intensity.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Skin wound, Urticaria
Clinical narrative: Delayed symptoms, not at  injection site. After approx 4-5 weeks, rash presenting at first as itchy papules in right elbow crease, erupting into painful red wheals over initial 2 wks. Left arm elbow crease red papules then appeared, itchy; also spreading into wheals; this then developed over forearm area. Skin color of right elbow crease  remains red with slight raised appearance, but right arm area pruritis diminishing. Left elbow crease and now forearm area worsened, eventually with large persistent itchy wheals, including from point of elbow to about 4? from wrist. Pressure or scratching leaves graphic trace wheals. As of Nov. 5 left forearm still marked with several  flatter red wheals, now mildly itchy, approx 2 to 2.5? diameter. Both arms initially had point-of-elbow involvement. Pruritis over forearm and elbow crease seemed to increase at end of day during initial period. Topical cortisone cream seemed to allay pain and itchiness. Neosporin applied to areas with broken skin from scratching; gauze bandaging overnight especially over highly inflamed left forearm. No pus nor red lines occured, mostly saw clear serum-like exudate. This spontaneous urticarial issue is novel to me. Lasting from approx August 17, 2022 to November 5, 2022 (present day) but is now diminishing in intensity.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: None stated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Injection site joint pain
Clinical narrative: Extreme joint pain in shoulders, elbows, wrists on both arms. This is the 2nd time I?ve experienced these symptoms/ 1st time was 4th shot. Same brand.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient felt very dizzy after receiving the vaccine
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired
Age: 10.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the monovalent Pfizer COVID-19 vaccine for their third dose instead of the bivalent vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Ocular hyperaemia
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient reported blood shot eyes on the same side as the arm they got the shot in.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster.
Age: 69.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the Monovalent PFIZER vaccine rather than the intended Bivalent PFIZER vaccine booster.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Chest pain, Dyspnoea, Immunology test normal, Mechanical urticaria
Clinical narrative: intense chest pain, shortness of breadth, severe bloating, dermatographia, intense skin irritation / itchyness  all occurred with 7 days of booster vaccine dose and did not subside for 6 months +   allergist physician at a local Medical Center refused to acknowledge any symptom other than dermatographia, prescribed double dose of zyrtec, claimed dermatographia was 'idiopathic' despite being statistically impossible to rule out vaccine as the cause  zyrtec minimized symptoms acutely, but exacerbated symptoms anytime the zyrtec dose was close to wearing off
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pulmonary function test normal, Skin irritation
Clinical narrative: intense chest pain, shortness of breadth, severe bloating, dermatographia, intense skin irritation / itchyness  all occurred with 7 days of booster vaccine dose and did not subside for 6 months +   allergist physician at a local Medical Center refused to acknowledge any symptom other than dermatographia, prescribed double dose of zyrtec, claimed dermatographia was 'idiopathic' despite being statistically impossible to rule out vaccine as the cause  zyrtec minimized symptoms acutely, but exacerbated symptoms anytime the zyrtec dose was close to wearing off
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Fatigue, Headache, Hot flush, Mood swings
Clinical narrative: Chronic pain that started a few weeks after the last shot, vaginal bleeding for 3 months, fatigue, hot flashes, mood swings, headaches
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: Chronic pain that started a few weeks after the last shot, vaginal bleeding for 3 months, fatigue, hot flashes, mood swings, headaches
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events experienced at the time of this documentation. Patient received incorrect vaccine and incorrect dose for patient's age.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: Stomach ache, flatulence, diarrhea last approximately 7 hours span
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Allodynia, Antinuclear antibody negative, Arthralgia, Balance disorder, Blood creatine phosphokinase normal
Clinical narrative: 8 hours after vax woke at 2AM on 9/9/22 to pain in Right groin/hip area radiating down the inside of my Right leg to my ankle. This pain became excruciating (10/10) over the next few hours. I could not put weight on my R leg or walk without assistance. I found that if I laid on my L side in a fetal position the pain was more tolerable, but any other position/movement was excruciating. At 3PM on 9/9/22 I went to the ER. They did labs and a Pelvic/hip CT and all results were normal. They ended up just treating my pain with 100 mg Fentanyl thru IV and sent me home with Rx for Oxycodone/Acetamenophin. On 9/10/22 I woke to find that my Right leg was mostly numb from the knee down, with areas of Allodynia. I also had
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood folate normal, C-reactive protein normal, Computerised tomogram abdomen normal, Computerised tomogram pelvis abnormal, Culture urine negative
Clinical narrative: 8 hours after vax woke at 2AM on 9/9/22 to pain in Right groin/hip area radiating down the inside of my Right leg to my ankle. This pain became excruciating (10/10) over the next few hours. I could not put weight on my R leg or walk without assistance. I found that if I laid on my L side in a fetal position the pain was more tolerable, but any other position/movement was excruciating. At 3PM on 9/9/22 I went to the ER. They did labs and a Pelvic/hip CT and all results were normal. They ended up just treating my pain with 100 mg Fentanyl thru IV and sent me home with Rx for Oxycodone/Acetamenophin. On 9/10/22 I woke to find that my Right leg was mostly numb from the knee down, with areas of Allodynia. I also had
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Differential white blood cell count normal, Electromyogram abnormal, Electrophoresis protein normal, Full blood count normal, Gait disturbance
Clinical narrative: 8 hours after vax woke at 2AM on 9/9/22 to pain in Right groin/hip area radiating down the inside of my Right leg to my ankle. This pain became excruciating (10/10) over the next few hours. I could not put weight on my R leg or walk without assistance. I found that if I laid on my L side in a fetal position the pain was more tolerable, but any other position/movement was excruciating. At 3PM on 9/9/22 I went to the ER. They did labs and a Pelvic/hip CT and all results were normal. They ended up just treating my pain with 100 mg Fentanyl thru IV and sent me home with Rx for Oxycodone/Acetamenophin. On 9/10/22 I woke to find that my Right leg was mostly numb from the knee down, with areas of Allodynia. I also had