chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Memory impairment
Clinical narrative: thought there were people in the house; He had an extremely bizarre incident that went on through the night; He did not know where we were, he did not recognized me, he did not knew our home; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Feb2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, single; had covid shots before ), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset 24Feb2025, outcome "recovered", described as "He had an extremely bizarre incident that went on through the night; He did not know where we were, he did not recognized me, he did not knew our home"; HALLUCINATION (medically significant) with onset 24Feb2025, outcome "recovered", described as "thought there were people in the house". Clinical course: The patient's wife reported that after receiving the COVID shot, the patient experienced an extremely bizarre incident that lasted through the night. Although the patient had received the COVID shot before, this time he did not recognize his wife and did not know their home. The patient also thought there were people in the house, which had never happened before. The patient's wife is asking if this could possibly be a side effect of the vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Cough, Decreased appetite, Dysphonia, Lethargy, Pyrexia
Clinical narrative: lingering cough; voice problems (hoarseness); fever; lethargy; no appetite; 11 lb weight loss; This is a spontaneous report received from an Other HCP, Program ID.  A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Dec2024 as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "lingering cough"; DYSPHONIA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "voice problems (hoarseness)"; PYREXIA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "fever"; LETHARGY (non-serious), 2 days after the suspect product(s) administration, outcome "unknown"; DECREASED APPETITE (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "no appetite"; WEIGHT DECREASED (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "11 lb weight loss". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: F
Vaccine: RSV
Symptoms: Weight decreased
Clinical narrative: lingering cough; voice problems (hoarseness); fever; lethargy; no appetite; 11 lb weight loss; This is a spontaneous report received from an Other HCP, Program ID.  A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Dec2024 as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "lingering cough"; DYSPHONIA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "voice problems (hoarseness)"; PYREXIA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "fever"; LETHARGY (non-serious), 2 days after the suspect product(s) administration, outcome "unknown"; DECREASED APPETITE (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "no appetite"; WEIGHT DECREASED (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "11 lb weight loss". Relevant laboratory tests and procedures are available in the appropriate section.
Vaccine: COVID19
Symptoms: Investigation, Thrombosis
Clinical narrative: they discovered 2 blood clots that were not there prior to vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 60-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "they discovered 2 blood clots that were not there prior to vaccine". The patient underwent the following laboratory tests and procedures: ATYA test: failed. Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient had originally received the Covid vaccine within a year of the outbreak. In 2023, while in the hospital they discovered 2 blood clots that were not there prior to vaccine. Coumadin was positive in clearing the clots. Patient was just told within the last 2 weeks that he/she failed a test for ATYA test, and going to see Hematologist it does seem that this deadly occurrence did come from the vaccine the patient got. The patient asked what kind of compensation is available for this. Patient just want to live a humble life.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested myself with the home test, and it said positive; I tested myself with the home test, and it said positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 55-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested myself with the home test, and it said positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Echocardiogram, Laboratory test
Clinical narrative: Next morning, increased weakness overall. Very dramatic.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient administered vaccine in clinic and returned to clinic 2 days later with concerns for potential vaccine reaction. Assessment was done by PCP in which redness and swelling was noted near site of vaccine administration. Patients' family was educated on additional signs and symptoms to watch for and additional fact finding and vaccine education was completed with staff at the clinic.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain, swelling. Itchiness, and redness in area of injection for about 3 weeks. Then difficulty lifting, bending, and weight bearing on left arm accompanied by pain in deltoid down to triceps that lasted 3 months. Gradual reduction in symptoms which occur intermittently at present time. Tenderness with palpation and some movements in areas of pain
Age: 59.0
Sex: M
Vaccine: PNC21
Symptoms: Fatigue, Flushing, Headache, Paraesthesia
Clinical narrative: FLUSHING HEADACHE FATIGUE TINGLING
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Anaphylactic reaction, Malaise, Peripheral swelling, Swollen tongue
Clinical narrative: Anaphylacic reaction: swelling in tonsils, massive swelling in arm spreading to forearm and close to wrist. Severe malaise.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Pt received extra dose of PREVNAR She received a dose 3/5/23 and a second dose that was not needed and given outside CDC guidelines on 2/22/2025
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Sore arm that progressed to red, swollen, itchy and hot, encompassing majority of bicep/upper ar. Places on antibiotics 2 days out.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received the RSV ( Arexvy ) vaccine in November 2023 and should not have received the Abrysvo per CDC recommendations. The patient has no reported side effects as of now.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Laboratory test, Myocarditis
Clinical narrative: Shortness of breath, difficulty breath. Md's suspect myocarditits. Patient still undergoing testing
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Nausea, Vomiting
Clinical narrative: Severe dizziness, nausea, vomiting and fatigue
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 1. Fever started day 2 (x 5 days) then resolved and 2. rash --> head to body started day 6      Fever resolved; Still has rash
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Fever, Headache, body aches the next day. Upper arm (left) swelling, redness, tenderness 13 x 17 cm erythema  Mother has pictures
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, Headache, body aches the next day. Upper arm (left) swelling, redness, tenderness 13 x 17 cm erythema  Mother has pictures
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A HCP called to inquire about how to administer a second dose of RECCOMBIVAX HB that would be late according to the recommended schedule.  The HCP stated a 32 year old patient received their first dose of RECOMBIVAX HB on 08/26/2024 and he was antici; No additional adverse event; This spontaneous report has been received from a nurse regarding a 32-year-old male patient. The patient's pertinent medical history, current conditions, concomitant medications, previous drug reactions or allergies were not reported. On 26-AUG-2024, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) suspension for injection (RECOMBIVAX HB), administered as prophylaxis 1 mL (Lot No. Y006509 has been verified to be a valid lot number for [hepatitis b vaccine (recombinant) suspension for injection], expiration date reported and upon internal validation established as 11-FEB-2027 (strength, route and anatomical location of administration and vaccination scheme frequency were not provided). It was stated that the nurse called to inquire about how to administer a second dose of the vaccine that would be late according to the recommended schedule as the patient supposed to come to the clinic to receive his second dose of the vaccine on 26-FEB-2025 (inappropriate schedule of product administration). No additional adverse event (AE) (no adverse event) was reported.
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: pediatric patient received Pediarix and Engerix-B the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (received on 24-SEP-2024).   On 03-FEB-2025, the patient received Engerix B and Pediarix. On 03-FEB-2025, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: pediatric patient received Pediarix and Engerix-B the same day). The outcome of the overdose was not applicable.   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: 03-FEB-2025. Practice Manager and explained that they administered an extra dose of Hepatitis B vaccine, since a pediatric patient received Pediarix and Engerix-B the same day which led to overdose. Caller mentioned that patient received a prior Pediarix dose and no prior Engerix-B doses.  Lot number and expiration date for the vaccines were not asked by the agent, but practice manager gave consent to follow up with safety if additional information was needed.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Guillain-Barre syndrome, Investigation
Clinical narrative: I had Guillain Barré with a very heavy paralysis; This spontaneous case was reported by a patient and describes the occurrence of GUILLAIN-BARRE SYNDROME (I had Guillain Barré with a very heavy paralysis) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. unknown) for COVID-19 prophylaxis.     Concomitant products included Immunoglobulins and Steroids for an unknown indication.    On 07-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 milliliter. On 22-Dec-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced GUILLAIN-BARRE SYNDROME (I had Guillain Barré with a very heavy paralysis) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy for Guillain-Barre syndrome. On 08-Jan-2023, GUILLAIN-BARRE SYNDROME (I had Guillain Barré with a very heavy paralysis) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: after many tests and differentiated diagnostics, I had Guillain Barré with a very heavy paralysis.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  After many tests and differentiated diagnostics, the patient had Guillain barre with a very heavy paralysis. The patient had full mobility now, after 2 years in physical rehab and therapies, the patient battles their consequences and sinkinesis in her face.   No treatment medications were reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-FEB-2025 This case was reported by a patient via interactive digital media. Patient had vaccine and got shingles twice last year. Still shingles with him/her 4 months later. The patient further said it would be good if it worked. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: MENB
Symptoms: Extra dose administered, Product label confusion
Clinical narrative: Product Confusion; This non-serious case was reported by a nurse via call center representative and described the occurrence of product label confusion in a patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced product label confusion (Verbatim: Product Confusion). The outcome of the product label confusion was not applicable.   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: 12-FEB-2025 The reporter was a nurse from a pediatric office.  She reports that they administer Bexsero vaccine. Inappropriate schedule of vaccine, the nurse states they order Bexsero and have been giving it at day one and one month later (as according to the old schedule) due to this an unknown number of patients would now have to receive a third dose.  The office staff were unaware of the dosing schedule change because they did not receive a notification. If they had known, they could have advised the patients not to return until the 6 month mark. The nurse was confused as to why the paper copy package insert inside the Bexsero vaccine box (which expires in 2027) would still be showing the original dosing schedule, which led to product label confusion. The vaccine administration facility was the same as primary reporter.
Age: 55.0
Sex: M
Vaccine: DTAPHEPBIP, TDAP
Symptoms: Dyspnoea, Heart rate increased, Nausea, Pain, Pyrexia
Clinical narrative: Fever pain in body nausea fast heart rate can?t breathe
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Despite prior vaccine, had quite severe case of shingles from 10/2023 - 1/2024
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth, Lymphocyte percentage, Neutrophil percentage, White blood cell count increased
Clinical narrative: Pt w/onset of progressive redness, warmth at injection site of Hib vaccine. Seen in office w/in 24hr - CBC checked with slight elevation WBC. Placed on Bactrim to cover possible abscess vs. localized site reaction.
Age: 90.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pain ongoing - from shoulder to elbow in right arm. Lump in (R) deltoid still present. Has tried ice + heat pads. heat helps. Taking ibuprofen + APAP Scheduled 3/3/25 w/PCP
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Bilateral shoulder and girdle pain.  Hand and neck pain  grip weakness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Shoulder girdle pain
Clinical narrative: Bilateral shoulder and girdle pain.  Hand and neck pain  grip weakness
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Alpha tumour necrosis factor increased, Biopsy skin abnormal, Burning sensation, Chronic fatigue syndrome, Cytokine increased
Clinical narrative: Burning and tingling of hands and feet, twitching, muscle weakness, headaches, crushing fatigue with post-exertional malaise,, myalgic encephalomyelitis, POTS, dizziness, vision changes with blurry vision and floaters, tinnitus. Complete loss of quality of life. Inability to exercise, work, or even get out of bed most days. Damn you Pfizer for lying to us. As a doctor myself, I am stunned at your unethical practices. Shame on you. You have ruined my life.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Exercise tolerance decreased, Fatigue, Headache, Impaired work ability
Clinical narrative: Burning and tingling of hands and feet, twitching, muscle weakness, headaches, crushing fatigue with post-exertional malaise,, myalgic encephalomyelitis, POTS, dizziness, vision changes with blurry vision and floaters, tinnitus. Complete loss of quality of life. Inability to exercise, work, or even get out of bed most days. Damn you Pfizer for lying to us. As a doctor myself, I am stunned at your unethical practices. Shame on you. You have ruined my life.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Interleukin level increased, Malaise, Mobility decreased, Muscle twitching, Muscular weakness
Clinical narrative: Burning and tingling of hands and feet, twitching, muscle weakness, headaches, crushing fatigue with post-exertional malaise,, myalgic encephalomyelitis, POTS, dizziness, vision changes with blurry vision and floaters, tinnitus. Complete loss of quality of life. Inability to exercise, work, or even get out of bed most days. Damn you Pfizer for lying to us. As a doctor myself, I am stunned at your unethical practices. Shame on you. You have ruined my life.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Postural orthostatic tachycardia syndrome, Quality of life decreased, Quantitative sudomotor axon reflex test, Tilt table test positive
Clinical narrative: Burning and tingling of hands and feet, twitching, muscle weakness, headaches, crushing fatigue with post-exertional malaise,, myalgic encephalomyelitis, POTS, dizziness, vision changes with blurry vision and floaters, tinnitus. Complete loss of quality of life. Inability to exercise, work, or even get out of bed most days. Damn you Pfizer for lying to us. As a doctor myself, I am stunned at your unethical practices. Shame on you. You have ruined my life.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vascular endothelial growth factor assay, Vision blurred, Vitreous floaters
Clinical narrative: Burning and tingling of hands and feet, twitching, muscle weakness, headaches, crushing fatigue with post-exertional malaise,, myalgic encephalomyelitis, POTS, dizziness, vision changes with blurry vision and floaters, tinnitus. Complete loss of quality of life. Inability to exercise, work, or even get out of bed most days. Damn you Pfizer for lying to us. As a doctor myself, I am stunned at your unethical practices. Shame on you. You have ruined my life.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Erythema, Feeling hot, Headache, Pruritus
Clinical narrative: Child had fever, swolle, hives , headaches , dizziness,  redness , hot to touch and itchy.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Child had fever, swolle, hives , headaches , dizziness,  redness , hot to touch and itchy.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a post beyond use date vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Brain fog, Loss of consciousness, Nervous system disorder
Clinical narrative: Per the patient the following day, after receiving the shingles vaccines, he passed out in the bathroom while brushing his teeth. He also felt weak for about 10days and has had a 'foggy' brain and his nerves are affected in his body.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states that she had immediate pain after the injection. She states that the pain continued to get worse in the shoulder and going all the way down the arm. She has since had difficulty lifting her arm and also reaching out with the arm. She has not followed up with a physician at this time.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Flushing, Headache, Pyrexia, Rash
Clinical narrative: Diarrhea, headache, fever, flushing in arm started within 24 hours of vaccine. Rash on arm started yesterday.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Alopecia, Pruritus, Rash
Clinical narrative: Hair loss starting about one month after vaccination. Started with steroid cream which did not improve hair loss. Itching/rash on hands and arms began in December 2024. used same steroid cream to treat which seems to have cleared hands and arms but not hair loss, hair loss getting progressively worse. December referred to dermatologist. Dermatologist did intramuscular steroid shots and prescribed a steroidal foam to use on scalp.  That seemed to slow hair loss. Still losing hair but not at the fast pace.
Age: 74.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction
Clinical narrative: Patient was administered the MenQuadfi booster on 2/27 and experienced a reaction 14 mins after administration at injection site
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swelling and redness of right upper arm
Age: 0.67
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Skin mass
Clinical narrative: ~2cm subcutaneous nodule occurred within 72 hours.  Slightly improved in the next 48 hours.  Patient well otherwise.
Age: 55.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had an injection site reaction in both arms - redness, swelling and warm to the touch, still present 48 hours after vaccination
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Insomnia
Clinical narrative: Upon the second dose of the vaccine, I shortly thereafter started experiencing a feeling of numbness with pins and needles feeling in the hands,arms,feet, and legs. The intensity would vary, and it could alternate between pins and needles or numbness or feeling of the body part "falling asleep." I also experience muscle fatigue and general fatigue. At that time, and for many months afterwards I would also have trouble sleeping and I would sometimes feel like I'm having an adrenaline rush during sleep and wake up. I would also have a feeling of numbness in the tongue or mouth, primarily during sleep, which had gone away over time.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle fatigue, Paraesthesia
Clinical narrative: Upon the second dose of the vaccine, I shortly thereafter started experiencing a feeling of numbness with pins and needles feeling in the hands,arms,feet, and legs. The intensity would vary, and it could alternate between pins and needles or numbness or feeling of the body part "falling asleep." I also experience muscle fatigue and general fatigue. At that time, and for many months afterwards I would also have trouble sleeping and I would sometimes feel like I'm having an adrenaline rush during sleep and wake up. I would also have a feeling of numbness in the tongue or mouth, primarily during sleep, which had gone away over time.
Age: 0.5
Sex: M
Vaccine: FLU3, PNC20, RV5, UNK
Symptoms: Urticaria
Clinical narrative: Day after vaccines given patient developed urticaria on his bilateral lower extremities. Recommend treatment with zyrtec and to contact his allergist as well.
Age: 60.0
Sex: M
Vaccine: CHIK, IPV, YF, CHIK, IPV, YF
Symptoms: Arthralgia, Dyspnoea, Joint swelling, Palpitations
Clinical narrative: Arthralgia, ankles, knees and swollen joints (ankles). Shortness of breath, heart palpitations
Age: 60.0
Sex: M
Vaccine: CHIK, IPV, YF, CHIK, IPV, YF
Symptoms: Arthralgia, Dyspnoea
Clinical narrative: Arthralgia, ankles, knees and swollen joints (ankles). Shortness of breath, heart palpitations
Age: 60.0
Sex: M
Vaccine: CHIK, IPV, YF, CHIK, IPV, YF
Symptoms: Arthralgia, Dyspnoea, Joint swelling, Palpitations
Clinical narrative: Client reported swelling to ankles and generalized joint pain.  He also reported mild shortness of breath but stated this could also be attributed to his asthma.  However, he saw the CDC alert about the chikungunya vaccine and felt he should report his symptoms.  He stated that the symptoms have been occurring for a few days.
Age: 60.0
Sex: M
Vaccine: CHIK, IPV, YF, CHIK, IPV, YF
Symptoms: Arthralgia, Dyspnoea
Clinical narrative: Client reported swelling to ankles and generalized joint pain.  He also reported mild shortness of breath but stated this could also be attributed to his asthma.  However, he saw the CDC alert about the chikungunya vaccine and felt he should report his symptoms.  He stated that the symptoms have been occurring for a few days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently given an extra dose of Shingrix vaccine.  No adverse reaction noted upon patient leaving clinic
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, warmth, and swelling noted 5 days later
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received the vaccine on Monday morning, 02/24/2025. On Thursday morning, 02/27/2025, patient stated that the vaccine site on her left arm was red and swollen, the area also has some itchiness.  She also endorses running nose, dry cough, and headaches that started on the morning of 02/27/2025.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Rhinorrhoea
Clinical narrative: Patient received the vaccine on Monday morning, 02/24/2025. On Thursday morning, 02/27/2025, patient stated that the vaccine site on her left arm was red and swollen, the area also has some itchiness.  She also endorses running nose, dry cough, and headaches that started on the morning of 02/27/2025.
Age: 79.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently given an extra doe of Shingrix vaccine.  No adverse reaction noted upon patient leaving clinic
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dyspepsia, Gastrooesophageal reflux disease, Nausea
Clinical narrative: Stomach pain.acid reflux, nausea, vomiting, heartburn, feeling faint, dizzy, lightheaded, all started one day after shot for 5-6 days. Made appt with gastroenterologist but appt was 2 months away
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Stomach pain.acid reflux, nausea, vomiting, heartburn, feeling faint, dizzy, lightheaded, all started one day after shot for 5-6 days. Made appt with gastroenterologist but appt was 2 months away
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received extra dose of prevnar 20
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: Fever same night of vaccines to 102F tmax.  Then this am febrile seizure questioned, but notably no post-ictal phase.  Having some emesis last night too, not today.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Affective disorder, Blood glucose fluctuation, Blood pressure fluctuation, Body temperature fluctuation
Clinical narrative: NEUROLOGICAL IMPAIRMENTS-  *Muscle cramps in hands, feet, legs.  *heart palpitations followed by episode of dysfunctional vagus nerve activity *dizziness *blood pressure dysregulation *heart palpitations*digestiv/bloate issues *mood (heightened emotions- sadder, softer emotions, i.e.- being overly touched by stories and events *swallowing issues,*shortness of breath, difficulty with *blood glucose dysregulation*body temp dysregulation *laying on the side  creates palpitation at  SA Node area of the heart related to VN *Fasting blood glucose  *Change in bowel movements *turning/tilting head and neck, laying down with chin on the chest can  create uncomfortable VN response *sensitive and  sometimes unbareable  to hot weather.* Poor metabolization of Prescription and OTC  drugs *VN reactions/issues while initially laying    down to fall asleep, palpitation and alarming increase in  BP causing veins  to appear on face & top    of hands. *On Oct. '24, cardiologist    referral to Neurologist     -alcohol consumption-
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Change of bowel habit, Dizziness, Dysphagia, Dyspnoea, Gastrointestinal disorder
Clinical narrative: NEUROLOGICAL IMPAIRMENTS-  *Muscle cramps in hands, feet, legs.  *heart palpitations followed by episode of dysfunctional vagus nerve activity *dizziness *blood pressure dysregulation *heart palpitations*digestiv/bloate issues *mood (heightened emotions- sadder, softer emotions, i.e.- being overly touched by stories and events *swallowing issues,*shortness of breath, difficulty with *blood glucose dysregulation*body temp dysregulation *laying on the side  creates palpitation at  SA Node area of the heart related to VN *Fasting blood glucose  *Change in bowel movements *turning/tilting head and neck, laying down with chin on the chest can  create uncomfortable VN response *sensitive and  sometimes unbareable  to hot weather.* Poor metabolization of Prescription and OTC  drugs *VN reactions/issues while initially laying    down to fall asleep, palpitation and alarming increase in  BP causing veins  to appear on face & top    of hands. *On Oct. '24, cardiologist    referral to Neurologist     -alcohol consumption-
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Gene mutation identification test, Metabolic disorder, Muscle spasms, Palpitations, Temperature intolerance
Clinical narrative: NEUROLOGICAL IMPAIRMENTS-  *Muscle cramps in hands, feet, legs.  *heart palpitations followed by episode of dysfunctional vagus nerve activity *dizziness *blood pressure dysregulation *heart palpitations*digestiv/bloate issues *mood (heightened emotions- sadder, softer emotions, i.e.- being overly touched by stories and events *swallowing issues,*shortness of breath, difficulty with *blood glucose dysregulation*body temp dysregulation *laying on the side  creates palpitation at  SA Node area of the heart related to VN *Fasting blood glucose  *Change in bowel movements *turning/tilting head and neck, laying down with chin on the chest can  create uncomfortable VN response *sensitive and  sometimes unbareable  to hot weather.* Poor metabolization of Prescription and OTC  drugs *VN reactions/issues while initially laying    down to fall asleep, palpitation and alarming increase in  BP causing veins  to appear on face & top    of hands. *On Oct. '24, cardiologist    referral to Neurologist     -alcohol consumption-
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vagus nerve disorder
Clinical narrative: NEUROLOGICAL IMPAIRMENTS-  *Muscle cramps in hands, feet, legs.  *heart palpitations followed by episode of dysfunctional vagus nerve activity *dizziness *blood pressure dysregulation *heart palpitations*digestiv/bloate issues *mood (heightened emotions- sadder, softer emotions, i.e.- being overly touched by stories and events *swallowing issues,*shortness of breath, difficulty with *blood glucose dysregulation*body temp dysregulation *laying on the side  creates palpitation at  SA Node area of the heart related to VN *Fasting blood glucose  *Change in bowel movements *turning/tilting head and neck, laying down with chin on the chest can  create uncomfortable VN response *sensitive and  sometimes unbareable  to hot weather.* Poor metabolization of Prescription and OTC  drugs *VN reactions/issues while initially laying    down to fall asleep, palpitation and alarming increase in  BP causing veins  to appear on face & top    of hands. *On Oct. '24, cardiologist    referral to Neurologist     -alcohol consumption-
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Antimicrobial susceptibility test resistant, Death, Septic shock
Clinical narrative: Nursing home facility communicated to the Pharmacy about death of the patient due to Septic shock and ESBL present in urine on 02/27/2025. The findings were shared with the pharmacy on 02/28/2025.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Ear infection, Flushing, Headache, Injection site erythema
Clinical narrative: Mother of patient reports patient started running fever on 2/26/25 around 3PM - patient is flushed and complaining of headache. Patient's  skin was burning up.  Mother of patient did  not measure  temp, but medicated with Tylenol. Fever improved. At midnight patient was "super hot" again. Mom gave more Tylenol and fever responds.  2/27/25 mother of patient reports patient's left thigh  is bright red and blotchy.  Mother of patient reports that patient is taking fluids and voiding, but  appetite is decreased.   Advised mother of patient it is not uncommon to have fever after vaccines,  may continue with Tylenol every 4 hours, may alternate with Motrin every 3 hours  if not responding well to Tylenol alone. Recommended measuring temp with recheck  after 1 hour to ensure response to medication.  Mother of patient denies any other rash.  Advised to push fluids to prevent dehydration.  Mother of patient reports the highest patient's temperature has been is 103.6. Pt.'s left thigh has mild redness on 2/28/25 in office. Pt. has been diagnosed with an ear infection on 2/28/25 in physician's office.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Pyrexia, Rash macular, Skin burning sensation
Clinical narrative: Mother of patient reports patient started running fever on 2/26/25 around 3PM - patient is flushed and complaining of headache. Patient's  skin was burning up.  Mother of patient did  not measure  temp, but medicated with Tylenol. Fever improved. At midnight patient was "super hot" again. Mom gave more Tylenol and fever responds.  2/27/25 mother of patient reports patient's left thigh  is bright red and blotchy.  Mother of patient reports that patient is taking fluids and voiding, but  appetite is decreased.   Advised mother of patient it is not uncommon to have fever after vaccines,  may continue with Tylenol every 4 hours, may alternate with Motrin every 3 hours  if not responding well to Tylenol alone. Recommended measuring temp with recheck  after 1 hour to ensure response to medication.  Mother of patient denies any other rash.  Advised to push fluids to prevent dehydration.  Mother of patient reports the highest patient's temperature has been is 103.6. Pt.'s left thigh has mild redness on 2/28/25 in office. Pt. has been diagnosed with an ear infection on 2/28/25 in physician's office.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Pruritus, Rash, Urticaria
Clinical narrative: Patient stated that he broke out in itchy hives on his arms and back. This started 3 days after getting the vaccine and he still has the rash on his back today (2/28/25). He doesn't recall changing anything in that period of time like soap, detergent, shampoo, taking any other new medications, or anything else new. He has gone to his dermatologist, and they stated that they believe it could just be dry skin because it is the winter, but the patient believes it is from the vaccine. The dermatologist suggested that this could be from the wood stove the patient has in the house, but the patient has been using the wood stove all winter and hasn't changed the type of wood used in it. The patient is going back to the dermatologist to get a full body exam to see if there is any other cause from it.
Age: 81.0
Sex: F
Vaccine: PNC21
Symptoms: Unevaluable event
Clinical narrative: adviced pt to ice and take benadryl
Age: 8.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: patient came to get vaccinations our vaccination system did not reflect a prevnar 20 being received already and patient stated they also did not remember getting one. we gave the vaccination per patient request and now it appears they also got one in 2023. patient is fine.
Age: 8.0
Sex: F
Vaccine: FLU3, IPV, MMRV, TDAP
Symptoms: Rash
Clinical narrative: Mother reported that the child developed a rash on her chest, belly, and back post vaccination. Per mom- the rash does not itch or hurt the child and the child is feeling ok. Alerted DON and county epi- following case per state guidelines.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV
Symptoms: Cough, Dyspnoea, Erythema, Hypersensitivity, Influenza virus test negative
Clinical narrative: Patient received his 4 yr vaccines (proquad and quadracel) on Tuesday at 5:00 PM, on Friday around 8:00 PM he started with fever. His temp was about 103, parents thought it could be from vaccines. He continued with the fever overnight. The following day he was red all over and had redness to one of his vaccine sites. He started getting swollen that morning (Saturday) before 12:00. He never had any trouble breathing. His body also had a lot of little bumps all over, then the following day (Sunday) the swelling got worse. Monday mom took him to urgent care (we were closed for holiday) Monday and they thought he was having an allergic reaction. The swelling was no worse between Sunday to Monday and it may have gotten a little better. They had been giving benadryl once a day, but are not sure if it made a significant difference. At urgent care, provider mentioned his throat was very swollen but mother says they did not notice any difference in his voice, throat clearing, or mouth itchiness. The fever was improving by Monday as well but did not go away completely until Thursday. He had fever through Wednesday.   Urgent care gave him steroid to bring the swelling down, then they also gave him amoxicillin for a possible ear infection (but they said it was mild - he had had clear fluid in his ear on the day of his WCC and has recurrent AOM), but it was switched to cefdinir on Wed when mother followed up in urgent care because he she told them he has had a lot of AOM failures. He did well with that antibiotic and will finish it today (10th day).   After the initial sx Friday - Monday, the following Tuesday - Friday he had congestion and cough like "he had a normal cold" that finally resolved on their own.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV
Symptoms: Injection site erythema, Joint swelling, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Patient received his 4 yr vaccines (proquad and quadracel) on Tuesday at 5:00 PM, on Friday around 8:00 PM he started with fever. His temp was about 103, parents thought it could be from vaccines. He continued with the fever overnight. The following day he was red all over and had redness to one of his vaccine sites. He started getting swollen that morning (Saturday) before 12:00. He never had any trouble breathing. His body also had a lot of little bumps all over, then the following day (Sunday) the swelling got worse. Monday mom took him to urgent care (we were closed for holiday) Monday and they thought he was having an allergic reaction. The swelling was no worse between Sunday to Monday and it may have gotten a little better. They had been giving benadryl once a day, but are not sure if it made a significant difference. At urgent care, provider mentioned his throat was very swollen but mother says they did not notice any difference in his voice, throat clearing, or mouth itchiness. The fever was improving by Monday as well but did not go away completely until Thursday. He had fever through Wednesday.   Urgent care gave him steroid to bring the swelling down, then they also gave him amoxicillin for a possible ear infection (but they said it was mild - he had had clear fluid in his ear on the day of his WCC and has recurrent AOM), but it was switched to cefdinir on Wed when mother followed up in urgent care because he she told them he has had a lot of AOM failures. He did well with that antibiotic and will finish it today (10th day).   After the initial sx Friday - Monday, the following Tuesday - Friday he had congestion and cough like "he had a normal cold" that finally resolved on their own.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV
Symptoms: Streptococcus test negative
Clinical narrative: Patient received his 4 yr vaccines (proquad and quadracel) on Tuesday at 5:00 PM, on Friday around 8:00 PM he started with fever. His temp was about 103, parents thought it could be from vaccines. He continued with the fever overnight. The following day he was red all over and had redness to one of his vaccine sites. He started getting swollen that morning (Saturday) before 12:00. He never had any trouble breathing. His body also had a lot of little bumps all over, then the following day (Sunday) the swelling got worse. Monday mom took him to urgent care (we were closed for holiday) Monday and they thought he was having an allergic reaction. The swelling was no worse between Sunday to Monday and it may have gotten a little better. They had been giving benadryl once a day, but are not sure if it made a significant difference. At urgent care, provider mentioned his throat was very swollen but mother says they did not notice any difference in his voice, throat clearing, or mouth itchiness. The fever was improving by Monday as well but did not go away completely until Thursday. He had fever through Wednesday.   Urgent care gave him steroid to bring the swelling down, then they also gave him amoxicillin for a possible ear infection (but they said it was mild - he had had clear fluid in his ear on the day of his WCC and has recurrent AOM), but it was switched to cefdinir on Wed when mother followed up in urgent care because he she told them he has had a lot of AOM failures. He did well with that antibiotic and will finish it today (10th day).   After the initial sx Friday - Monday, the following Tuesday - Friday he had congestion and cough like "he had a normal cold" that finally resolved on their own.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient has 2"x 2" raised, red injection site reaction. Hot to touch and itchy. Still itching and red on day 2 (2/28/25).  Counseled the patient to use antihistamine by mouth or benadryl and/or hydrocortisone cream topically as needed for the redness and itching.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, COVID-19, Fluid retention, Magnetic resonance imaging abnormal
Clinical narrative: After i got that vaccine something happened. I started catching Covid too many times , i have had it 5 times and i didnt feel right, i didnt feel the same. I started getting back pain i thought it was kidney but it wasn't. They sent me to  Hospital to get an MRI. The hospital called me and said i had stage 3 arthritis in my hips. Next week i have to see an Orthopedic doctor. My body is retaining fluid and i have to take meds to get it to get out and it makes my heart palpitate. I had to start cholesterol pills.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations
Clinical narrative: After i got that vaccine something happened. I started catching Covid too many times , i have had it 5 times and i didnt feel right, i didnt feel the same. I started getting back pain i thought it was kidney but it wasn't. They sent me to  Hospital to get an MRI. The hospital called me and said i had stage 3 arthritis in my hips. Next week i have to see an Orthopedic doctor. My body is retaining fluid and i have to take meds to get it to get out and it makes my heart palpitate. I had to start cholesterol pills.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt reported having leg pain the evening after the vaccine until now (4 days later) until it became unbearable and she was brought to the clinic and referred to the ER