chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Arexvy and Shingrix exposed at 51.1F for 6 weeks  have been administered to patients; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2024, the patients received Shingrix and Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patients experienced incorrect storage of drug (Verbatim: Arexvy and Shingrix exposed at 51.1F for 6 weeks have been administered to patients). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The pharmacist reported that the Arexvy and Shingrix exposed at 51.1 degree fahrenheit for 6 weeks (not stable).  The pharmacist reported that last week (not specified) the vaccines could have been administered to patients (did not have information on which patients, which vaccines or date of administration) which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received only the adjuvant component of a Shingrix vaccine and not the reconstituted vaccine; received only the adjuvant component of a Shingrix vaccine and not the reconstituted vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant component of a Shingrix vaccine and not the reconstituted vaccine) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant component of a Shingrix vaccine and not the reconstituted vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The reporter who stated that a patient received only the adjuvant component of a Shingrix vaccine and not the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient already has 3 Dtap, IPV, Hib and hep B. With this Kinrix shot, patient has 4 Dtap and 4 IPV; administered Kinrix by error to a 15 months baby; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J) for prophylaxis.   Previously administered products included Dtap (received 4 Dtap on an unknown date), IPV (received 4 IPV on an unknown date), Hib (received Hib vaccine on an unknown date) and Hep B vaccine (received Hep B vaccine on an unknown date).   On 13-SEP-2024, the patient received Kinrix. On 13-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: patient already has 3 Dtap, IPV, Hib and hep B. With this Kinrix shot, patient has 4 Dtap and 4 IPV) and inappropriate age at vaccine administration (Verbatim: administered Kinrix by error to a 15 months baby). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:28-OCT-2024 The reporter reported that a nurse colleague administered Kinrix by error to a 15 month patient which led to inappropriate age at vaccine administration. The patient already had Dtap, IPV, Hib and hep B vaccine with this Kinrix shot, patient had 4 Dtap and 4 IPV vaccine which led to, inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: medical assistant administering a dose of ACT-HIB that was reconstituted with sterile water instead of the 0.4 % Sodium Chloride to a patient with no  reported adverse event; also stated that the product had been administered to a patient with no reported adverse event; Initial information received on 07-Nov-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who was administered with a dose of Hib (Prp/T) Vaccine [Act-Hib] that was reconstituted with sterile water instead of the 0.4 % sodium chloride, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap), Influenza vaccine (Flu) and Pneumococcal Vaccine Conj 20v (Crm197) (Pneumococcal Vaccine Conj 20v (CRM197)) for Immunisation.  On 06-Nov-2024, the patient received 0.5 ml, once dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: standard), which was reconstituted with sterile water instead of the 0.4 % sodium chloride by assistant, with no reported adverse event (product preparation error) and (poor quality product administered) (latency: same day) (lot: UK016AC, Expiry date: 31-May-2025) via intramuscular route in the right vastus lateralis for Immunization.  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.; Sender's Comments:  US-SA-2024SA329787:02296620
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: extreme fatigue, muscle soreness, whole body chills, loss of appetite
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: Vaccine administered high in shoulder, less than two fingers down from acromion process. Significant shoulder pain began shortly after vaccine and persists. Tylenol ineffective to relieve pain.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient (10),  her mother (43) and her father (43) receieved seasonal flu vaccine stated above at approximately 5:30 PM. Patient was first followed by parents . Patient was quite calm and appeared excited to receive the shot. Upon completion with about 5 minutes Patient collapsed in a store aisle adjacent to the Immunization Area. I observed her father kneeling over her and immediately dialed EMS to report the emergency. Upon stating the emergency (girl appeared to have fainted) and location I was question as to whether breathing (yes) and conscience (yes). These responses were provided by parents. By then parents had placed patient in a chair and  I went to the scene to await arrival of first responders. I provided mom with a chair and poice officer arrived within approximately five (5) minutes followed by  EMTs shortly thereafter. Patient was evaluated at that tiome. Parents were asked if they want her vitals taken in the ambulance they said "yes" and I asked if they would prefer doing that in the Immunization Area . Thet agreed. Her blood pressure normal and temperature normal. Parents agreed to take daughter home. I place a call to mother two hours later . She had eaten dinner and was feeling back to normal.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Paraesthesia
Clinical narrative: Patient states that his skin in various dermatomal places has been tender to touch. It started over the right side of his distal forearm/wrist. That resolved, but the tenderness mobilized to the posterior left shoulder. Now over the left clavicle and left upper arm. It mimics tenderness and tingling.
Age: 72.0
Sex: U
Vaccine: SMALL
Symptoms: Headache
Clinical narrative: headache
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest discomfort, Hot flush, Hypoaesthesia, Malaise
Clinical narrative: Feeling flush, stomach pain with nausea, tightness to mid section of body, numbness to right arm/hand lasting 5 days with no improvement. Nausea was only the day after, but generally felt not right since vaccine was administered.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Feeling flush, stomach pain with nausea, tightness to mid section of body, numbness to right arm/hand lasting 5 days with no improvement. Nausea was only the day after, but generally felt not right since vaccine was administered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Meniere's disease
Clinical narrative: Within 2 weeks I had resurgence of Ménière's Disease that was debilitating. Was incapacitated for months.  It had previously been dormant for 10 years. Only an event typically can re-trigger this. I deduced the vaccine had to be the culprit and have had no vaccines of any kind since then out of fear.
Age: 81.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received the Arexvy vaccine twice (11/18/24 and 9/6/23) and the Fluad vaccine twice (11/18/24 and 9/6/24). Tried calling patient twice to ask if any side effects but it went to voice mail.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Asthenia, Cardiac telemetry, Chest discomfort, Cold sweat
Clinical narrative: Fast heartbeat, Cold Sweats, Dizziness, Difficulty breathing, Weakness, Flushed, felt like someone was sitting on my chest, pain in left and right arms, happened about an hour after I had gotten this year's Flu shot at my doctor's office.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Flushing, Heart rate increased
Clinical narrative: Fast heartbeat, Cold Sweats, Dizziness, Difficulty breathing, Weakness, Flushed, felt like someone was sitting on my chest, pain in left and right arms, happened about an hour after I had gotten this year's Flu shot at my doctor's office.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Fast heartbeat, Cold Sweats, Dizziness, Difficulty breathing, Weakness, Flushed, felt like someone was sitting on my chest, pain in left and right arms, happened about an hour after I had gotten this year's Flu shot at my doctor's office.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Contusion, Nodule, Rash
Clinical narrative: Rash, bruising, knot
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3, MNQ, TDAP
Symptoms: Blood test, Bradycardia, Pallor, Syncope, Vomiting
Clinical narrative: Within 5 minutes patient fainted and vomited X1. Pt was layed down and vitals were obtained.  Pt was bradycardic and pale.    Pt recovered ok within 30 minutes.  Vitals returned to normal.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: 14 Year old girl was administered an expired vaccine but a provider onsite
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAD ALREADY RECEIVED AN INFLUENZA VACCINE ON 10/11/2024 WHILE INPATIENT IN THE HOSPITAL. HE ERRANTLY RECEIVED A SECOND INFLUENZA VACCINE IN OUR PHARMACY. THE PATIENT AND THE PATIENT'S FAMILY HAVE NOT REPORTED ANY ADVERSE EVENTS RELATED TO RECEIVING A SECOND INFLUENZA VACCINE.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient returned for Covid vaccination 11/10/24 and stated that after flu immunization her arm was stiff and sore. She had talked with a friend who was a healthcare provider and she felt that the flu vaccination had been given too high on the arm resulting in the stiffness.
Age: 11.0
Sex: M
Vaccine: FLU3, MENB
Symptoms: Malaise, Oropharyngeal pain, Pain
Clinical narrative: Patient was feeling ill the next day with mild body aches and sore throat.
Age: 89.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea, Endotracheal intubation
Clinical narrative: day following vaccination patient was having difficulty breathing.  It progressed and patient went to hospital Friday or Saturday.  Patient is currently hospitalized and intubated.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RSV immunization given to 36 year old female with chronic illness. No adverse reactions. Vaccine given outside of age requirements.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Accident, Autopsy, Death, Drowning
Clinical narrative: Pt drowned while kayaking on Sept 23, but he was wearing a life vest and felt normal that day.   He had never had a reaction to influenza vaccine prior, but concern for his sudden death after so soon after the vaccine administration.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Postural tremor, Restlessness
Clinical narrative: Kinetic/postural tremor, muscle aching/restlessness of the upper extremities bilaterally sparing shoulder girdle; reported symptoms to PCP, symptoms persist but have improved slightly
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: patient has been experiencing  severe joint pain since the day following vaccination
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA increased
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES; HOSPITALIZED 10/23/24-10/26/24
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3, HEPA
Symptoms: Dizziness, Malaise, Vision blurred
Clinical narrative: Patient reported malaise, dizziness, and blurred vision that progresses throughout the day
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Joint swelling, Peripheral swelling, Urticaria, Vertigo
Clinical narrative: A day after receiving Shingrix #1, patient reported ankle and foot swelling, hives on the face, and dizziness (room spinning) intermittently for about two days. He took OTC Benadryl at home and symptoms are now resolved.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA increased
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE; HOSPITALIZED 10/29/24-10/31/24
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received high dose flu vaccine when intent was to administer standard dose flu vaccine.
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Biopsy skin, Blood test, Loss of personal independence in daily activities, Rash, Rash vesicular
Clinical narrative: Experienced blistering rash that spread throughout my right armpit and left open sores on my torso, in my armpit and up the inside of my right bicept. The sores were very painful, prone to infection and significantly adversely impacted my ability to function normally.
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Wound
Clinical narrative: Experienced blistering rash that spread throughout my right armpit and left open sores on my torso, in my armpit and up the inside of my right bicept. The sores were very painful, prone to infection and significantly adversely impacted my ability to function normally.
Age: 7.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Pneumococcal Polysaccharide vaccine was expired when it was given. Expiration date was 8/12/24 and vaccine was given on 11/6/24. There were no adverse effects or outcomes. Patient will be reimmunized.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Malaise, Pyrexia
Clinical narrative: FLULAVAL TRIVALENT 2024-25 SYR,          Administration date  - 2024-10-09        Expiration date -2025-06-02 .   I received the vaccine and the next day I experienced low grade fever, malaise for 2 days and asthma reactions the next day continuing for 3 weeks.  During that 3 weeks post vaccine, I self-treated with my Proventil inhaler multiple times a day.  I finally saw Dr who treated me with a course of Prednisone tabs x1 week.  I did not have other signs of any infection and I do not normally need to use my inhaler unless I have a URI.  I was not treated with any antibiotics and within 10 days the respiratory symptoms resolved.  I do believe the vaccine directly affected my breathing and caused my SOB and difficulty breathing.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity, Rash, Rash papular, Swelling, Tenderness
Clinical narrative: Swelling and rash starting 24 hours post injection in the injected arm. Noticed pain and raised rash in the morning after injection.  I took ibuprofen at that time.   I took diphenhydramine yesterday. Today (11/19) I am noticing diminishing swelling and less rash.  Still tender to touch.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Injection site discolouration, Injection site haemorrhage, Injection site infection, Injection site swelling
Clinical narrative: Patient's skin fluffed off. Skin around administration stie is pale, got rough, and started to bleed. Then turned pink, raised, and inflamed.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: Patient's skin fluffed off. Skin around administration stie is pale, got rough, and started to bleed. Then turned pink, raised, and inflamed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Idiopathic urticaria, Swelling of eyelid
Clinical narrative: Already had a flare of chronic idiopathic urticaria (hives primarily confined to face and controlled with zyrtec). After the vaccine, hives drastically spread around face, chest, abdomen, back, buttocks, and genital region. They were uncontrolled with zyrtec, steroids, and montelukast. Complication of hives included severe eyelid swelling to the point where it was difficult to open eyes.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Not an adverse event but the vaccine was administered subcutaneous versus IM.  No injury known at this time.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Pt states they started having a fever over 100 the same night of immunization and woke the following morning with a rash on their right forearm. The rash is red itchy and has about 20 bumps. Fever has gone away but rash has persisted.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cardiac arrest, Death
Clinical narrative: Client died 10/23/2024   Cardiac arrest
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 3 weeks post injection soreness remains to left deltoid with somewhat limited range of motion
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, X-ray abnormal
Clinical narrative: pt states that a couple of getting the covid vaccine that she started having extreme pain in her left knee. She went to Urgent Care. They took an xray and found she had bone on bone with her knee. She feels that the shot aggravated her knee because of her history of her inflammatory syndrome and GCA. She was referred to the orthopedic doctor for the pain. Dr. gave her a shot and precribed her to have physical therapy.  She had just taken of baby aspirin prior the vaccination. She will follow up with her doctor after the PT. Pt took unknow flu vaccine at PCP office in Sept.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram, Echocardiogram, Electrocardiogram, Interstitial lung disease
Clinical narrative: PFIZER #1 5/7/2021 PFIZER #2 5/28/2021 DEVELOPED ACUTE COVID-19 AFTER VACCINATION AND VACCINE AND INFECTION ASSOCIATED INTERSITIAL LUNG DISEASE.  TREATED WITH COURSES OF ANTIBIOTICS AND IVERMECTIN AND COLCHICINE WITH PROTOCOL BASE SPIKE DETOXIFICATION
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pulmonary function test
Clinical narrative: PFIZER #1 5/7/2021 PFIZER #2 5/28/2021 DEVELOPED ACUTE COVID-19 AFTER VACCINATION AND VACCINE AND INFECTION ASSOCIATED INTERSITIAL LUNG DISEASE.  TREATED WITH COURSES OF ANTIBIOTICS AND IVERMECTIN AND COLCHICINE WITH PROTOCOL BASE SPIKE DETOXIFICATION
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child was inadvertently given an expired vaccine (Expired on 11/08/24). She is clinically doing fine without any side effects or problems.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA increased
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES. HOSPITALIZED 11/15/24-11/16/24
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose decreased, Dyspnoea, Insomnia, Tremor
Clinical narrative: 1. Low blood sugar, 2. Insomnia, 3. Shaking, 4. Shortness of Breath
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Injury
Clinical narrative: Office Homemaker Department was notified on 11/7/24 that client had fallen and was hospitalized, unknown injuries.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Rash, Rash erythematous
Clinical narrative: Student complain of a headache and not feeling well at the 15 minute mark after the vaccination.  Blood pressure 101/83, HR 166bpm, Lungs clear; after five minutes deep pink rash appeared to face and neck area, No complain of shortness of breath or difficulty swallowing, no hives present. Student rested in the clinic, ice given for headache, reassessed at 11:00 a.m. rash  slightly pink to face and no rash to neck.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states she has soreness in the arm since receiving the vaccine. There is no bruising or lumping. She said the soreness is still there since receiving it almost a month ago.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hydrocele, Testicular cyst, Testicular pain, Ultrasound testes abnormal, Varicocele
Clinical narrative: I had been feeling intermediate minor to medium pain and discomfort in my right testicle for 2 or 3 weeks (not sure if it started before or after my COVID-19 vaccination). On Nov 13 when I woke up I had increased and constant pain in my right testicle (4 or 5 out of 10) the pain increased over the next 24 hours to a 6 or 7 out of 10 at which point I went to the ER in the afternoon of Nov 14. At the ER I received a testicle exam and ultrasound. I was told nothing major was wrong except for some swelling and was sent home with instructions to alternate between OTC Advil and acetaminophen. Over the next couple days the pain decreased to low or near non-existent levels however there is still some discomfort in the right testicle. I have a follow up with a urologist upcoming
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Flu vaccine on 10-8-24; transitioned to another facility and during second facility flu clinic patient requested and was administered a Flu vaccine on 10-31-24. No adverse reaction.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash vesicular
Clinical narrative: Patient experienced a rash that started on his left lower arm on 11/07/2024. The rash has gradually spread over the T2 dermatome to his upper arm and upper back.  Rash appears to have a cluster-like shingles appears, accompanied with left arm pain.
Sex: M
Vaccine: RSV
Symptoms: Irritability, Product administered to patient of inappropriate age
Clinical narrative: 27 day old infant was given adult RSV bivalent vaccine instead of monoclonal antibody approved for infants. Error discovered soon after vaccination, MD requested infant be brought back next day for Beyfortus and check up.  Per MOC, patient had been more fussy than usual after the vaccination but no other adverse effects were noted.
Age: 1.08
Sex: F
Vaccine: DTPPVHBHPB, FLU3, HEPA, HIBV, MMRV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Vaxelis vaccine in error.  Was ordered for Varicella and MMR separately and instead received Vaxelis and MMRV.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Nodule
Clinical narrative: PATIENT REPORTS TWO SMALL KNOTS IN THE DELTOID MUSCLE WITH RED RAISED AREA ; PATIENT REPORTS AREA IS NOT PAINFUL OR ITCHY ; STILL PERSISTING 21 DAYS AFTER VACCINE ADMINISTRATION
Age: 0.33
Sex: M
Vaccine: PNC15, RV5, VARCEL
Symptoms: Pyrexia
Clinical narrative: baby developed a high fever an hour after vaccine and had an on going fever for 72 hours was told to take baby to ER which mother did so and was seen by ER
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness neurosensory
Clinical narrative: Previously reported sudden sensory neural hearing loss R ear due to my body attacking its own immune system.  Now: After receiving Shingrix vaccine Sept 2020  I have had recurrent shingles outbreaks beginning Oct 2021. I have had 4 out breaks most recently Nov 2024. After reviewing online I see that shingles can be activated by vaccine. Knowing that my immune system caused hearing loss it seems to correlate with my recurrent shingles outbreak
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Patient returned to pharmacy 11/18/24 to report that she had come to the pharmacy for an influenza vaccine, but that she now realized she has received a Moderna COVID vaccine instead. The patient began to feel fatigue, body aches, and fever on 11/19/24 through 11/20/24.  No other symptoms were reported. The patient is also concerned that she had menstrual irregularity/gynecological symptoms with previous COVID vaccines and may have those issues again.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Wrong product administered
Clinical narrative: The patient came the pharmacy 11/18/2024 stating he had come on 11/14/2024 for a flu shot and realized that he had received a Moderna COVID vaccine in error. The patient stated he started to feel body aches, fatigue, and fever on 11/15/24, last into 11/16/24.
Age: 28.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product distribution issue
Clinical narrative: On 11/12/2024 the patient came in for a consult for traveling.  Patient was needing a Polio booster (per CDC recommendations) for her trip.  At 8:15AM, the client was given the SQ injection of IPOL.  Later that morning, this nurse became aware during the vaccine wasn't received within 2 days from shipment.  Per the manufacturer's instructions, the vaccine is to be received within 2 days of shipping.  If it is not received within 2 days, the manufacturer cannot guarantee the vaccine was kept at the proper temperature.  Therefore, we cannot guarantee long-term immunity for the person vaccinated.  When we called the patient to report the possible temperature excursion during the shipment process, the patient did not report any adverse effects following the appointment.  The patient has been rescheduled at this time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: patient received the vaccine 11/14/24.  The next morning an area of 2inx3in was raised , swollen ,red, itchyand there was pain at the injection site. .  Patient did not describe any fever or constitutional symptoms.   She applied benadryl cream to the area for 4 days and took benadryl 50mg at night.  Today 11/19/24 pt presented with no issues in that area, and the redness has resolved.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Diarrhoea, Fatigue, Pain, Peripheral coldness
Clinical narrative: On November 14th I started to feel fatigued and agitated. On the evening of the 15th I had very cold hands and feet, body aches, and diarrhea. Between the 15th and 18th I had Diarrhea approximately 20 times. I am a breastfeeding mother (9 month old baby). The baby developed flu like symptoms on the 16th: runny nose, sneezing, and coughing. The baby still has those symptoms today. Myself and the baby had no symptoms before the vaccine. No one else in my household has any symptoms. No one else in my household received the vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anxiety, Chest discomfort, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Trouble breathing that was not responsive to my inhaler, chest pain, chest tightness, extreme fatigue
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: this patient has pain for 10 days, per pt, pt cannot raise the left arm since the last flu shot. informed this patient to contact doctor if patient cannot tolerate pain.
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 0.1mg Menquadfi was administered transdermal instead of ordered tuberculin. No adverse reaction yet reported.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Shortly after getting flu vaccine today started breaking out in hives. Given benadryl 5 ml and monitored on office for 30 min. No further reaction
Age: 27.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: On 11/7/2024 the patient came in for immunizations.  Patient was needing a Polio vaccine per requirements.  At 11:20AM the client was given the SQ injection of IPOL.  On 11/12/2024, this nurse became aware the vaccine  wasn't received within 2 days from shipment date.  Per the manufacturer's instructions, the vaccine is to be received within 2 days of shipping.  If it is not received within 2 days, the manufacturer cannot guarantee the vaccine was kept at the proper temperature.  Therefore, we cannot guarantee long-term immunity for the person vaccinated.  When we called the patient to report the possible temperature excursion during the shipment process, the patient did not answer so a voicemail was left and the patient was advised to call the clinic back.  The patient will be rescheduled if/when he calls back.
Age: 49.0
Sex: F
Vaccine: HEP, IPV, MMR
Symptoms: Product storage error
Clinical narrative: On 11/6/2024 the patient came in for immunizations.  Patient was needing a Polio vaccine per requirements.  At 1:30PM the client was given the SQ injection of IPOL.  On 11/12/2024, this nurse became aware the vaccine  wasn't received within 2 days from shipment date.  Per the manufacturer's instructions, the vaccine is to be received within 2 days of shipping.  If it is not received within 2 days, the manufacturer cannot guarantee the vaccine was kept at the proper temperature.  Therefore, we cannot guarantee long-term immunity for the person vaccinated.  When we called the patient to report the possible temperature excursion during the shipment process, the patient reported no problems during the phone call.  The patient was then rescheduled and will be re vaccinated.  Staff was consulted for translation since the patient doesn't speak the language.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac operation, Coronary artery occlusion, Myocardial infarction
Clinical narrative: Severe blockage of the right corinary artery, heartache, emergancy medivac, unsuccessful  stent proceedure, week of medication but second stent attempt failed, open heart surgery.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Mother called and claims that the vaccine was administered too high and now her son is in pain. Mother refuses to administer tylenol or ibuprofen to son.
Age: 59.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: On 11/5/2024 the patient came in for immunizations for travel.  Patient was needing a Polio vaccine per CDC recommendations.  At 11:15AM the client was given the SQ injection of IPOL.  On 11/12/2024, this nurse became aware the vaccine  wasn't received within 2 days from shipment date.  Per the manufacturer's instructions, the vaccine is to be received within 2 days of shipping.  If it is not received within 2 days, the manufacturer cannot guarantee the vaccine was kept at the proper temperature.  Therefore, we cannot guarantee long-term immunity for the person vaccinated.  When we called the patient to report the possible temperature excursion during the shipment process, the patient reported no adverse reaction and was able to schedule an appointment to be re vaccinated.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Asthenopia, Diplopia, Eye patch application, Mobility decreased, Strabismus
Clinical narrative: Patient received the multi vaccine in her right thigh and the Hib and PCV13 in her left thigh on 10/15/2014. I asked the nurse if this was too much for her body to take at once, and she reassured me that it was fine. The shots are labeled as "DTap-HepB-IPV+, HIB-PRP-T, and PCV13" on her shot record. About an hour after returning home from the doctor's office, I noticed the entire left side of her body was not moving. She was awake and alert, and wiggling her right arm and legs, but the left side of her body was motionless. I panicked and called my husband at his work. We prayed. My intuition told me this was a direct result from the vaccines. About two hours later that same day, she began to move again.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Canalith repositioning procedure, Vertigo
Clinical narrative: Onset of significant vertigo, saw GP and Physical Therapist, did Epley maneuver, symptoms still come and go
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received dose of vaccine one mth  prior to current dose given. Patient displayed no adverse reactions to vaccine. Tolerated well.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt called on 11/14/24 to report having a slight reaction to vaccine received on 11/12/24.  She noticed on 11/13/2024 a slightly red and bumpy area (rash like) at cite of injection.  Reaction already resolving by 11/14/24.  Nothing reportedly taken as a result of this reaction.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 101.3 with inconsolability - treated with tylenol, fever resolves and returned 6 hours later at 100.8- treated with tylenol again
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Sweating, nausea, lightheadedness
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Mouth swelling, Swollen tongue
Clinical narrative: PT REPORTS REACTION TO 1ST SHINGRIX VACCINE- THE NEXT DAY PT HAD EXTREME DRY MOUTH, ORAL MUCOSAL SWELLING, SWELLING ON TONGUE, CHANGE IN LINGUAL STRUCTURE. WENT TO DENTIST THEN ENT THEN TO PRIMARY CARE.  PRIMARY CARE STARTED PT ON FAMOTIDINE TO TAKE SWELLING DOWN WHICH HELPED. PRIMARY CARE ADVISED NOT TO GET 2ND DOSE. OVERALL, SEVERE FOR 10 TO 12 DAYS THEN GRADUALLY DIMINISHED ONCE STARTED FAMOTIDINE.  NO HOSPITALIZATION.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Vaccine was administered in the Tricep muscle on 11/17/2024.  Patient went to ER with arm pain and redness on 11/18/2024. ER provider called pharmacy to notify of incident.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Electromyogram abnormal, Fatigue, Paraesthesia
Clinical narrative: I developed paresthesia on my feet and legs the following day after the vaccination, in addition to fatigue. The symptoms appeared to improve/resolve but continue to recurred and consulted with my primary care provider. Had an EMG done that was reported as borderline. Over time the paresthesia and fatigue wax and wane, but the last few days have been more constant.  A couple of weeks ago will only have them at the end of the day, now they appear on the middle of the day. The paresthesia are present on my upper and lower extremities, lips (mainly upper) and sometimes in the chest.
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Dizziness, Dysphagia, Dyspnoea, Injection site pruritus
Clinical narrative: fever, tmax 100.4, chills, body aches, right arm pain, itchiness around right arm site of injection with palpable warmth, dizziness, sore throat, difficulty breathing or swallowing (improved prior to seeing patient for appointment).
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever, tmax 100.4, chills, body aches, right arm pain, itchiness around right arm site of injection with palpable warmth, dizziness, sore throat, difficulty breathing or swallowing (improved prior to seeing patient for appointment).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Anosmia, Chills, Decreased appetite, Fatigue
Clinical narrative: fatigue, nausea, headache, vomited once, nausea, anorexia, unable to smell food, insides felt like they were shaking, stomach pains, muscle cramp, right arm pain not at the vaccinated side, left arm after vaccine had normal aching, fevers for 6 days, chills and sweating
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Influenza virus test negative, Leukopenia, Muscle spasms
Clinical narrative: fatigue, nausea, headache, vomited once, nausea, anorexia, unable to smell food, insides felt like they were shaking, stomach pains, muscle cramp, right arm pain not at the vaccinated side, left arm after vaccine had normal aching, fevers for 6 days, chills and sweating
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nervousness, Neutrophil count decreased, Pain in extremity, Platelet count decreased
Clinical narrative: fatigue, nausea, headache, vomited once, nausea, anorexia, unable to smell food, insides felt like they were shaking, stomach pains, muscle cramp, right arm pain not at the vaccinated side, left arm after vaccine had normal aching, fevers for 6 days, chills and sweating
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vomiting, White blood cell count decreased
Clinical narrative: fatigue, nausea, headache, vomited once, nausea, anorexia, unable to smell food, insides felt like they were shaking, stomach pains, muscle cramp, right arm pain not at the vaccinated side, left arm after vaccine had normal aching, fevers for 6 days, chills and sweating
Age: 53.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Lymph node pain, Oropharyngeal pain
Clinical narrative: Sore lymph nodes in left neck and left submandibular region.  Mild sore throat. MD feels it is reactive to mild viral infection.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Flushing, Heart rate increased, Pyrexia
Clinical narrative: Fever and discomfort with elevated heart rate, followed by upper arm redness and flushing 4 days post vaccine. General pinpoint rash on limbs neck and face.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Fever and discomfort with elevated heart rate, followed by upper arm redness and flushing 4 days post vaccine. General pinpoint rash on limbs neck and face.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: The patient developed Guillain-Barre syndrome after the vaccination.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies
Clinical narrative: The patient developed Guillain-Barre syndrome after the vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Pt states after 3 hours of injection given she stated having  fever, SOB, N/V and arm pain. She used her inhaler for SOB which got better and Ibuprofen for fever.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced extreme arm pain in the left arm starting Sunday 11/17/24. Patient was not able to lift his arm or grab anything with that hand without pain. Patient also started having diarrhea 11/19/24.  As of 11/19/24 the pain is worse than before.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: The patient's daughter reported swollen nose from receiving Fluzone HD vaccine. The patient's swollen nose was getting better on Wednesday AM after we called her.. Not sure if completely resolved .
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Abscess limb, Arthralgia, Arthritis bacterial, Escherichia test positive, Infective myositis
Clinical narrative: Patient received influenza vaccine on 11/1/24. On 11/3/24, he presented to ER complaining of right shoulder pain. At this time, there was no swelling, no warmth, no redness. Team felt he was having a local reaction to the influenza vaccination. On 11/9/24, patient again presented to ER complaining of shoulder pain. No new findings, labs, or imaging. Patient given IM dose of opioids and started on oral corticosteroids. On 11/17/24, pt was admitted to hospital and diagnosed with right arm abscess and infective myocytis and septic joint. Multiple cultures from the right shoulder grew E. coli. Infectious disease provider was contacted and indicated no clear source for hematogenous seeding. Concern for contamination of injection site at the time of vaccination or contamination of the vaccine itself.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Vomiting
Clinical narrative: Patient received second dose in our office on 9/17. Patient then went home and developed emesis. Had repeated episodes. Seen the next day in our office and I personally diagnosed intussusception. Sent to ED and US confirmed  intussusception
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain lower, Back pain, Chills, Diarrhoea, Fatigue
Clinical narrative: Report from client 'for 24 hours after vaccine started having back pain, fatigue, headache, chills, diarrhea, low abdominal pain, vision change-- lasted about 72 hours.  Treated at home with Tylenol and fluids, did go to DNP and got physical therapy referral for  Epley maneuver which helps with continued stretches and will continue to see. Headaches subsided after about 10 days.  Labs suggested but did not do them. '
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Visual impairment
Clinical narrative: Report from client 'for 24 hours after vaccine started having back pain, fatigue, headache, chills, diarrhea, low abdominal pain, vision change-- lasted about 72 hours.  Treated at home with Tylenol and fluids, did go to DNP and got physical therapy referral for  Epley maneuver which helps with continued stretches and will continue to see. Headaches subsided after about 10 days.  Labs suggested but did not do them. '
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast tenderness, Pain in extremity, Urticaria
Clinical narrative: Patient reported slight hives on face. She also complained about a very sore arm and tenderness of the breast area.
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3, HPV9
Symptoms: Deafness, Headache, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Client received 2nd dose of HPV, seasonal COVID-19 (Pfizer-Comirnaty), and seasonal flu shot (Flulaval). Client and mom were in waiting room post immunization for 15-minute observation period. Client was provided a drink. Between 2-5 minutes post immunization around 2:30 PM, mom stated that client was not feeling well. Client was observed to be diaphoretic and pale. Client reported to nurses symptoms of nausea and some loss of hearing. Nurses asked client if she would like to lie down and client agreed. Nurses brought out mat to waiting room and client lowered herself down to the mat and laid down. Nurses then gave client ice packs to apply on back of neck and on forehead. Client was also given emesis bag and nurses advised client to take deep breaths. At 2:31 PM, nurses took automatic blood pressure while client was lying down. BP was 91/39, HR 54. Client was still diaphoretic and pale and nurses continued to tell client to take deep breaths and continued to apply ice packs. At 2:33 PM, nurses took manual BP and BP was 90/60 and client started to become less pale and less diaphoretic. At 2:35 PM, client stated that she did not feel faint and that hearing is back to normal, but had headache around forehead area and rated it 5/10. Client did not appear diaphoretic or pale. Client reported no vision changes. At 2:41 PM, client was able to sit up on mat by herself. Nurses offered client water and client drank 1 cup of water. Nurses took automatic BP and BP was 116/74, HR 57. At 2:44 PM, client stated that headache was improving and client rated headache as 3/10. Client then got up and sat in chair by herself. At 2:50 PM, nurses took automatic BP and BP was 111/59, HR 52. At 2:51 PM, client was able to stand up on her own and states that she no longer felt a headache and stated that headache is 0/10. Client stated that she no longer felt any symptoms and felt okay to go home. Client observed to walk with steady gait and was no longer pale or diaphoretic, and did not appear to have any other symptoms. Client also confirmed and stated to not have any other symptoms. Advised client and client's mother to follow up with client's primary care doctor and to seek emergency care if symptoms return, or if client starts experiencing new symptoms.
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3, HPV9
Symptoms: Pallor
Clinical narrative: Client received 2nd dose of HPV, seasonal COVID-19 (Pfizer-Comirnaty), and seasonal flu shot (Flulaval). Client and mom were in waiting room post immunization for 15-minute observation period. Client was provided a drink. Between 2-5 minutes post immunization around 2:30 PM, mom stated that client was not feeling well. Client was observed to be diaphoretic and pale. Client reported to nurses symptoms of nausea and some loss of hearing. Nurses asked client if she would like to lie down and client agreed. Nurses brought out mat to waiting room and client lowered herself down to the mat and laid down. Nurses then gave client ice packs to apply on back of neck and on forehead. Client was also given emesis bag and nurses advised client to take deep breaths. At 2:31 PM, nurses took automatic blood pressure while client was lying down. BP was 91/39, HR 54. Client was still diaphoretic and pale and nurses continued to tell client to take deep breaths and continued to apply ice packs. At 2:33 PM, nurses took manual BP and BP was 90/60 and client started to become less pale and less diaphoretic. At 2:35 PM, client stated that she did not feel faint and that hearing is back to normal, but had headache around forehead area and rated it 5/10. Client did not appear diaphoretic or pale. Client reported no vision changes. At 2:41 PM, client was able to sit up on mat by herself. Nurses offered client water and client drank 1 cup of water. Nurses took automatic BP and BP was 116/74, HR 57. At 2:44 PM, client stated that headache was improving and client rated headache as 3/10. Client then got up and sat in chair by herself. At 2:50 PM, nurses took automatic BP and BP was 111/59, HR 52. At 2:51 PM, client was able to stand up on her own and states that she no longer felt a headache and stated that headache is 0/10. Client stated that she no longer felt any symptoms and felt okay to go home. Client observed to walk with steady gait and was no longer pale or diaphoretic, and did not appear to have any other symptoms. Client also confirmed and stated to not have any other symptoms. Advised client and client's mother to follow up with client's primary care doctor and to seek emergency care if symptoms return, or if client starts experiencing new symptoms.