chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume abnormal, Mean platelet volume normal, Monocyte count normal
Clinical narrative: Patient is here for her well-child check.  She was given her HPV vaccine at the start of the visit approx. 8:56 am. She was sitting on the bench next her mom said I feel tired, slumped to the right and had brief loss of consciousness. She came to and we transferred her up onto the exam room table. An urgent response was called. We reentered the room mom noticed that her eyes were fluttering, she is holding her head turned to the right. She was minimally responsive, but able to identify where she is at and answer simple questions.  Her speech is quite dysarthric.  She seemed to have a slight droop of her right face, and tongue deviates to the right when protruded.  Pupils are equal round reactive to light, but she has a lagging gaze with some horizontal nystagmus.  Initially when she smiled there was drooping on the right but that has subsequently resolved.  She continues to hold her head turned to the right. Decision was made to activate EMS for transport to the hospital.  On their arrival, she still had dysarthric speech but was starting to joke and asked to go to school.  She was able to stand and transfer to the stretcher with some support, though still seems weak.  Continues to have a slight rightward head tilt, but has a symmetric smile now.  We are approximately 40 minutes out from vaccine administration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Monocyte percentage increased, Neutrophil count decreased, Neutrophil percentage decreased, Nystagmus, Platelet count increased
Clinical narrative: Patient is here for her well-child check.  She was given her HPV vaccine at the start of the visit approx. 8:56 am. She was sitting on the bench next her mom said I feel tired, slumped to the right and had brief loss of consciousness. She came to and we transferred her up onto the exam room table. An urgent response was called. We reentered the room mom noticed that her eyes were fluttering, she is holding her head turned to the right. She was minimally responsive, but able to identify where she is at and answer simple questions.  Her speech is quite dysarthric.  She seemed to have a slight droop of her right face, and tongue deviates to the right when protruded.  Pupils are equal round reactive to light, but she has a lagging gaze with some horizontal nystagmus.  Initially when she smiled there was drooping on the right but that has subsequently resolved.  She continues to hold her head turned to the right. Decision was made to activate EMS for transport to the hospital.  On their arrival, she still had dysarthric speech but was starting to joke and asked to go to school.  She was able to stand and transfer to the stretcher with some support, though still seems weak.  Continues to have a slight rightward head tilt, but has a symmetric smile now.  We are approximately 40 minutes out from vaccine administration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Posture abnormal, Protein total normal, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal
Clinical narrative: Patient is here for her well-child check.  She was given her HPV vaccine at the start of the visit approx. 8:56 am. She was sitting on the bench next her mom said I feel tired, slumped to the right and had brief loss of consciousness. She came to and we transferred her up onto the exam room table. An urgent response was called. We reentered the room mom noticed that her eyes were fluttering, she is holding her head turned to the right. She was minimally responsive, but able to identify where she is at and answer simple questions.  Her speech is quite dysarthric.  She seemed to have a slight droop of her right face, and tongue deviates to the right when protruded.  Pupils are equal round reactive to light, but she has a lagging gaze with some horizontal nystagmus.  Initially when she smiled there was drooping on the right but that has subsequently resolved.  She continues to hold her head turned to the right. Decision was made to activate EMS for transport to the hospital.  On their arrival, she still had dysarthric speech but was starting to joke and asked to go to school.  She was able to stand and transfer to the stretcher with some support, though still seems weak.  Continues to have a slight rightward head tilt, but has a symmetric smile now.  We are approximately 40 minutes out from vaccine administration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Tongue movement disturbance, White blood cell count normal
Clinical narrative: Patient is here for her well-child check.  She was given her HPV vaccine at the start of the visit approx. 8:56 am. She was sitting on the bench next her mom said I feel tired, slumped to the right and had brief loss of consciousness. She came to and we transferred her up onto the exam room table. An urgent response was called. We reentered the room mom noticed that her eyes were fluttering, she is holding her head turned to the right. She was minimally responsive, but able to identify where she is at and answer simple questions.  Her speech is quite dysarthric.  She seemed to have a slight droop of her right face, and tongue deviates to the right when protruded.  Pupils are equal round reactive to light, but she has a lagging gaze with some horizontal nystagmus.  Initially when she smiled there was drooping on the right but that has subsequently resolved.  She continues to hold her head turned to the right. Decision was made to activate EMS for transport to the hospital.  On their arrival, she still had dysarthric speech but was starting to joke and asked to go to school.  She was able to stand and transfer to the stretcher with some support, though still seems weak.  Continues to have a slight rightward head tilt, but has a symmetric smile now.  We are approximately 40 minutes out from vaccine administration.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Hypoaesthesia, Injection site pustule, Mobility decreased, Sepsis
Clinical narrative: Bloody puss pockets at injection site that turned septic within days.  Loss of feeling in both my bicep and triceps. I still struggle to lift my arm. Extreme rage that lasted for several weeks.
Age: 66.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient reports left side facial and lip numbness starting the morning following vaccines. She reports still having some numbness today 2/17/25 after receiving vaccines 1/30/25.
Age: 8.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: No adverse event
Clinical narrative: There were no adverse reactions
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual cycles.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: Parent stated that pt developed hives to left thigh and left side of face hours after he received vaccines. She took him to Emergency Department on 1/16/24 at 6pm
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Crying, High-pitched crying, Infant irritability, Infantile back arching, Screaming
Clinical narrative: Patient had multiple nights of severe high pitched screaming/crying, fussiness, arching of back, inconsolability, with signs and symptoms of encephalitis.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: No adverse events noted
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Joint swelling, Pyrexia, Rash, Rash erythematous
Clinical narrative: Salmon colored rash all over her body that moved around, high fever.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Cold sweat, Loss of consciousness, Pallor
Clinical narrative: On 02/14/2025 donor presented to clinic for donation.  After she completed a donation she was scheduled to receive the Vaccinia Vaccination.  Post Immunization the donor started to feel clammy, Pallor Skin or lips and also had LOC for less then 60 seconds.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, MENB
Symptoms: Syncope
Clinical narrative: Patient fainted after being given the vaccines while walking out of the room.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Chest congestion, cough, shortness of breath x5 days
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given Pediatric dose of 10 mcg/0.5 mL instead of adult dose 20 mcg/1 mL.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: ; LotNumber: ; Route: same arm; BodySite: same arm; Dose: ; VaxDate: UNKNOWN
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Other Vaccines:  VaccineTypeBrand: boostrix tdap; Manufacturer: GSK; LotNumber: 9429j; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: menveo a-c-y-w; Manufacturer: GSK; LotNumber: xl223; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Other Vaccines:  VaccineTypeBrand: boostrix tdap; Manufacturer: GSK; LotNumber: 9429j; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: menveo a-c-y-w; Manufacturer: GSK; LotNumber: xl223; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Biopsy skin abnormal, Blood test abnormal, Fatigue
Clinical narrative: Description of Symptoms (This description was given to Dr. rheumatologist on my 1st visit on Dec. 5, 2023) On March 9, 2021 I took my first dose of the Covid Vaccine and immediately had reactions to the shot. These reactions were within the first 24 hours after the shot. ( I took the second dose two weeks later and then the required booster shots.) My lymph nodes did swell and when I would sit down to eat I had difficulty chewing because it would seem to swell them further.  It would cause anxiety every time I ate.  Also, I developed at the same time an unexplained rash on my left leg and then later my right leg that would cause a lot of itching.  I have continued to have these problems and my doctors and dermatologists could not seem to help.  The inflammation comes and goes on my rash with each episode leaving permanent scarring on my skin.  Every time it flares up it spreads wider and has even spread to my other leg.   I just recently was seen by Dermatologists (Sept. 11, 2023) and they did a biopsy of which I have the report results.  They gave me a cortisone shot and it seemed to help temporarily.  I need to find what is causing this reaction. According to the biopsy report, I was advised to check further since it showed some kind of auto immune response.  My next appointment was at Allergy where I was sent to lab for an intense blood work on all possible allergies and then later came back for a thorough airborne allergy skin testing.  The blood work seemed to confirm an auto immune response.   I have been experiencing unexplained fatigue whereby my whole body just aches and nothing seems to help except laying down and sleeping it off.  I can experience aches concentrated on the certain areas marked on your questionnaire to all over achiness .  I don?t know if all this is related to my rashes and lymph node swellings . Last week and through today it is concentrated on my right knee.  2 weeks ago was my right shoulder which felt like I was being stabbed sharply.  The week before that (3 weeks ago) it was concentrated on my left shoulder and it felt very painful to touch right at the joint. Since my appoiintment with Dr. MD I have been referred to Dr. (Rhuematologist MD) . Dr. diagnosed me as having RA but referred me out for second opinion.  Dr. diagnosed me with Polymyalgia Rheumatica.  The medicines prescribed for my condition have been Hydroxychloroquine and Prednisone.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy, Mastication disorder, Pain, Polymyalgia rheumatica
Clinical narrative: Description of Symptoms (This description was given to Dr. rheumatologist on my 1st visit on Dec. 5, 2023) On March 9, 2021 I took my first dose of the Covid Vaccine and immediately had reactions to the shot. These reactions were within the first 24 hours after the shot. ( I took the second dose two weeks later and then the required booster shots.) My lymph nodes did swell and when I would sit down to eat I had difficulty chewing because it would seem to swell them further.  It would cause anxiety every time I ate.  Also, I developed at the same time an unexplained rash on my left leg and then later my right leg that would cause a lot of itching.  I have continued to have these problems and my doctors and dermatologists could not seem to help.  The inflammation comes and goes on my rash with each episode leaving permanent scarring on my skin.  Every time it flares up it spreads wider and has even spread to my other leg.   I just recently was seen by Dermatologists (Sept. 11, 2023) and they did a biopsy of which I have the report results.  They gave me a cortisone shot and it seemed to help temporarily.  I need to find what is causing this reaction. According to the biopsy report, I was advised to check further since it showed some kind of auto immune response.  My next appointment was at Allergy where I was sent to lab for an intense blood work on all possible allergies and then later came back for a thorough airborne allergy skin testing.  The blood work seemed to confirm an auto immune response.   I have been experiencing unexplained fatigue whereby my whole body just aches and nothing seems to help except laying down and sleeping it off.  I can experience aches concentrated on the certain areas marked on your questionnaire to all over achiness .  I don?t know if all this is related to my rashes and lymph node swellings . Last week and through today it is concentrated on my right knee.  2 weeks ago was my right shoulder which felt like I was being stabbed sharply.  The week before that (3 weeks ago) it was concentrated on my left shoulder and it felt very painful to touch right at the joint. Since my appoiintment with Dr. MD I have been referred to Dr. (Rhuematologist MD) . Dr. diagnosed me as having RA but referred me out for second opinion.  Dr. diagnosed me with Polymyalgia Rheumatica.  The medicines prescribed for my condition have been Hydroxychloroquine and Prednisone.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Scar, Skin test, Tenderness
Clinical narrative: Description of Symptoms (This description was given to Dr. rheumatologist on my 1st visit on Dec. 5, 2023) On March 9, 2021 I took my first dose of the Covid Vaccine and immediately had reactions to the shot. These reactions were within the first 24 hours after the shot. ( I took the second dose two weeks later and then the required booster shots.) My lymph nodes did swell and when I would sit down to eat I had difficulty chewing because it would seem to swell them further.  It would cause anxiety every time I ate.  Also, I developed at the same time an unexplained rash on my left leg and then later my right leg that would cause a lot of itching.  I have continued to have these problems and my doctors and dermatologists could not seem to help.  The inflammation comes and goes on my rash with each episode leaving permanent scarring on my skin.  Every time it flares up it spreads wider and has even spread to my other leg.   I just recently was seen by Dermatologists (Sept. 11, 2023) and they did a biopsy of which I have the report results.  They gave me a cortisone shot and it seemed to help temporarily.  I need to find what is causing this reaction. According to the biopsy report, I was advised to check further since it showed some kind of auto immune response.  My next appointment was at Allergy where I was sent to lab for an intense blood work on all possible allergies and then later came back for a thorough airborne allergy skin testing.  The blood work seemed to confirm an auto immune response.   I have been experiencing unexplained fatigue whereby my whole body just aches and nothing seems to help except laying down and sleeping it off.  I can experience aches concentrated on the certain areas marked on your questionnaire to all over achiness .  I don?t know if all this is related to my rashes and lymph node swellings . Last week and through today it is concentrated on my right knee.  2 weeks ago was my right shoulder which felt like I was being stabbed sharply.  The week before that (3 weeks ago) it was concentrated on my left shoulder and it felt very painful to touch right at the joint. Since my appoiintment with Dr. MD I have been referred to Dr. (Rhuematologist MD) . Dr. diagnosed me as having RA but referred me out for second opinion.  Dr. diagnosed me with Polymyalgia Rheumatica.  The medicines prescribed for my condition have been Hydroxychloroquine and Prednisone.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness and pain around injection site starting 2 days after injection. no longer red but still painful today 2/17/25
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient was given dose of vaccine before the vaccine  was completely thawed. Given approximately 30 minutes early, before correct thaw time.  After consultation with Moderna and our senior staff as well as physician, patient was determined to not need revaccination
Age: 71.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Patient reported over phone: woke the next morning to a "knot" on her arm at the vaccine site and well as some redness. The redness  has since spread as far as her elbow. Patient states that is is itchy as well.
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Left should pain and loss of mobility
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Confusional state, Death, Dyspnoea, Fatigue
Clinical narrative: Upon awakening on October 25, 2024, which was the morning following the administration of the COVID 19 vaccination given on October 24, 2024, his finger stick blood sugar was very high for him 177 (for the last 2 years his range has been 100-134, except on approximately 3 occasions after eating sweets the night prior), headache, intense fatigue, nausea, vomiting which continued through the night. The next morning on October 26, 2024, upon awakening his finger stick blood sugar was 174, again high for him especially with minimal intake, the symptoms from the day prior worsened during the day with additional new symptoms of shortness of breath, difficulty breathing, confusion and skin cool to the touch at which time EMS was called. Prior to their arrival, he became unconscious but breathing. He was transported to the nearest hospital and he was pronounced dead at 11:18pm (on October 26, 2024) which was shortly after arrival.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Peripheral coldness, Vomiting
Clinical narrative: Upon awakening on October 25, 2024, which was the morning following the administration of the COVID 19 vaccination given on October 24, 2024, his finger stick blood sugar was very high for him 177 (for the last 2 years his range has been 100-134, except on approximately 3 occasions after eating sweets the night prior), headache, intense fatigue, nausea, vomiting which continued through the night. The next morning on October 26, 2024, upon awakening his finger stick blood sugar was 174, again high for him especially with minimal intake, the symptoms from the day prior worsened during the day with additional new symptoms of shortness of breath, difficulty breathing, confusion and skin cool to the touch at which time EMS was called. Prior to their arrival, he became unconscious but breathing. He was transported to the nearest hospital and he was pronounced dead at 11:18pm (on October 26, 2024) which was shortly after arrival.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Influenza like illness, Injection site discomfort
Clinical narrative: After approximately 36 hours post vaccination I began to experience mild flu-like symptoms ( low fever, night sweating, upset stomach) in addition mild discomfort at injection site. On Monday 2/3/25 I woke up to intense and debilitating joint pain in my lower back which progressed the same day to both hips. Was in severe discomfort and was unable to stand up straight and could barely walk. The pain intensified over the next few days. On Wednesday 2/5/2205 the joint paint had not subsided and I began to experience muscle aches and spasms throughout both legs. It is now 2/17/25 and the pain is only beginning to subside with standing and walking becoming more comfortable. Prior to the shingles vaccination I had rarely if ever experience body aches and pains and had exercised daily for a minimum of 30 minutes. I am still unable to exercise.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Myalgia
Clinical narrative: After approximately 36 hours post vaccination I began to experience mild flu-like symptoms ( low fever, night sweating, upset stomach) in addition mild discomfort at injection site. On Monday 2/3/25 I woke up to intense and debilitating joint pain in my lower back which progressed the same day to both hips. Was in severe discomfort and was unable to stand up straight and could barely walk. The pain intensified over the next few days. On Wednesday 2/5/2205 the joint paint had not subsided and I began to experience muscle aches and spasms throughout both legs. It is now 2/17/25 and the pain is only beginning to subside with standing and walking becoming more comfortable. Prior to the shingles vaccination I had rarely if ever experience body aches and pains and had exercised daily for a minimum of 30 minutes. I am still unable to exercise.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; to have shingles this month; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: to have shingles this month). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2025 This case was reported by a patient via (Shingles) interactive digital media. The patient received both doses of shingles vaccine in 2023 and 2024 and had shingles this month. The patient stated the good thing was did not had the blistering rash. The patient felt compel to let everyone know that they can have shingles without an outbreak.  The patient stated please get vaccinated and maybe, should you come down with shingles, you will not have a rash. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year old female patient received a dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 31-OCT-2024, the patient received Infanrix. On 31-OCT-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 10 year old female patient received a dose of Infanrix). The outcome of the inappropriate age at vaccine administration was 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: 10-FEB-2025 The Vaccine Administration Facility was the same as Primary Reporter The Certified Medical Assistant called to report that a 10 year old patient received a dose of Infanrix vaccine, which led to inappropriate age at vaccine administration. They wanted to know if the patient needed to receive another dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Food poisoning, SARS-CoV-2 test
Clinical narrative: was ill with food poisoning; tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of FOOD POISONING (was ill with food poisoning) and COVID-19 (tested positive for COVID-19) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 13-Jan-2025,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (tested positive for COVID-19). On an unknown date, the patient experienced FOOD POISONING (was ill with food poisoning). At the time of the report, FOOD POISONING (was ill with food poisoning) outcome was unknown and COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2025, SARS-CoV-2 test: Positive. On 20-Jan-2025, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported. She was originally set to receive the new COVID vaccine for the 2024-2025 season in Dec-2024, but due to food poisoning, her appointment was postponed to Jan-2025. On 13-Jan-2025, she tested positive for COVID-19 and missed the rescheduled vaccination. She had severe cold-like symptoms, including a runny nose and sneezing, but denied having a cough. Although she suspected it wasn't COVID, her daughter encouraged her to get tested. Ultimately, she tested negative on 20-Jan-2025, with no further information available. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: body aches; migraine; fever; nausea; exhaustion; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Feb2025 at 15:45 as dose 1, single (Lot number: LN0591) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LO LOESTRIN FE, start date: Apr2015; SPIRONOLACTONE, start date: Jan2015. The following information was reported: PAIN (non-serious) with onset 09Feb2025 at 23:45, outcome "recovered" (12Feb2025), described as "body aches"; FATIGUE (non-serious) with onset 09Feb2025 at 23:45, outcome "recovered" (12Feb2025), described as "exhaustion"; PYREXIA (non-serious) with onset 09Feb2025 at 23:45, outcome "recovered" (12Feb2025), described as "fever"; MIGRAINE (non-serious) with onset 09Feb2025 at 23:45, outcome "recovered" (12Feb2025); NAUSEA (non-serious) with onset 09Feb2025 at 23:45, outcome "recovered" (12Feb2025). Therapeutic measures were not taken as a result of pain, migraine, pyrexia, nausea, fatigue.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s).
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Pain, Pain in extremity, X-ray
Clinical narrative: pain in his arm/hurting; barely can move my right arm/can barely move his arm; in pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in his arm/hurting"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "barely can move my right arm/can barely move his arm"; PAIN (non-serious), outcome "unknown", described as "in pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller said he took the Pfizer COVID vaccine and experienced pain in his arm and he would like to know how to remove the protein inside his body. per caller calling regarding Pfizer covid19 vaccine received vaccination per caller when you bombarded us with information you are going to die if you don't take a shot, 2-3 years ago  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: arm was sore; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult (60-64 years old) female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in 2025 as unk, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (hospitalization) with onset 2025, outcome "unknown", described as "arm was sore". Clinical course: This season; patient received the flu and Covid vaccines at the same time; in the same arm; so the scenarios were familiar. Arm was sore for a couple of days.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Feeling hot, Pallor
Clinical narrative: patient blood pressure dropped, face pale and patient was feeling warm about 15 -  minutes after getting immunization administered. patient said he gets very nervous about needles and it lasts around 20 minutes or so - happened during a blood draw about two months ago and when he watched his wife get an iv - after EMS came to evaluate patient and it was mentioned it may be vasovagal syncope patient said he remembered at his blood draw being told something about that (this information was not listed on his patient consent/questionnaire form - patient denied transport to the hospital via ambulance and was advised to go to a walk-in clinic or talk with his primary and given instructions of what to do if anything happens after leaving, wife was with him who verbalized understanding
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Aldosterone/renin ratio, Blood chromogranin A, Blood magnesium normal, Blood thyroid stimulating hormone normal, Coma
Clinical narrative: Patient reports labile hypertension after COVID vaccination. Currently, he is not taking any medications. He is managed through lifestyle and monitoring at this time.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Labile hypertension, Lipids normal
Clinical narrative: Patient reports labile hypertension after COVID vaccination. Currently, he is not taking any medications. He is managed through lifestyle and monitoring at this time.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Injection site hot, red, painful, decreased ROM at the shoulder.  Sent to ER concern for cellulitis.  Dx'd DVT brachial vein.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site warmth, Ultrasound Doppler abnormal
Clinical narrative: Injection site hot, red, painful, decreased ROM at the shoulder.  Sent to ER concern for cellulitis.  Dx'd DVT brachial vein.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Angioplasty, Coronary angioplasty, Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: Adverse Event: 1.Massive Heart Attack in Proximal Circumflex Artery Segment -.  Treatment: 1. Coronary angiogram 2. Percutaneous transluminal angioplasty and primary intracoronary stent placement to the   CxOM and balloon angioplasty of the Cx 3. Intravascular ultrasound of the Cx-OM
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Adverse Event: 1.Massive Heart Attack in Proximal Circumflex Artery Segment -.  Treatment: 1. Coronary angiogram 2. Percutaneous transluminal angioplasty and primary intracoronary stent placement to the   CxOM and balloon angioplasty of the Cx 3. Intravascular ultrasound of the Cx-OM
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Hypoaesthesia
Clinical narrative: patient said his feet went numb. He said he went to his physicians office 3 times the first day. he received the vaccine and within 6 hours of the vaccine he was having numbness in his feet.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dry skin, Erythema, Urticaria
Clinical narrative: Reported that after eating lunch, about an hour after vaccine, developed HA, facial urticaria. No SOB, no fever, no swelling noted; Drank Tylenol & HA resolved. Washed face with soap & water but itchiness persisted; client observed actively scratching face, slight redness in left cheek, forehead, side of nose, dry skin but no hives; no hives observed elsewhere in body; Reported not eating anything or applying anything on skin that is "new"; CNP on site suggested 25mg diphenhydranine PO then & another 25mg after if itchiness persisted. Contacted mother who game permission to treat; instructed to bring to ED if symptoms do not resolve or worsens.  Reported to school counselor a day later stating HA gone but took dipenhydramine as itchiness persists.  Reported to school counselor a day later stating HA gone but took dipenhydramine once more and itchiness resolved.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: patient got arexvy at 36 weeks which its not indicated for. patient does not have any side effects but since it does not have and indication for it we need to report it.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: patient got arexvy at 36 weeks which its not indicated for. patient does not have any side effects but since it does not have and indication for it we need to report it.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Autoimmune disorder, Blood test, Condition aggravated, Decreased appetite
Clinical narrative: Increased swelling in my right forearm and right hand, which resulted in blood tests, specifically a RA panel that was initially reported a positive ANA factor and had to seek out Rheumatology. I waited 16 months to be treated for the inflammatory auto immune disorder that was shown in my blood work. By this point my right forearm and right hand were so swollen, numbness and tingling. I began forming large dense nodules on the palms of both hands. Was then directed to a hand surgeon. Insomnia, excess sweating, nightmares and extreme daytime sleepiness, which resulted in getting a sleep study done that showed no pertinent results. Extreme weight loss, decrease appetite, which resulted in seeing my primary care doctor.  I went from 114lbs to 91lbs in a short 8 months. Ended up under the treatment of neurology due to major depression, insomnia, and sleep walking. Neurology provided me a referral for counseling.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Insomnia, Magnetic resonance imaging, Major depression
Clinical narrative: Increased swelling in my right forearm and right hand, which resulted in blood tests, specifically a RA panel that was initially reported a positive ANA factor and had to seek out Rheumatology. I waited 16 months to be treated for the inflammatory auto immune disorder that was shown in my blood work. By this point my right forearm and right hand were so swollen, numbness and tingling. I began forming large dense nodules on the palms of both hands. Was then directed to a hand surgeon. Insomnia, excess sweating, nightmares and extreme daytime sleepiness, which resulted in getting a sleep study done that showed no pertinent results. Extreme weight loss, decrease appetite, which resulted in seeing my primary care doctor.  I went from 114lbs to 91lbs in a short 8 months. Ended up under the treatment of neurology due to major depression, insomnia, and sleep walking. Neurology provided me a referral for counseling.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nightmare, Nodule, Paraesthesia, Peripheral swelling, Sleep study normal
Clinical narrative: Increased swelling in my right forearm and right hand, which resulted in blood tests, specifically a RA panel that was initially reported a positive ANA factor and had to seek out Rheumatology. I waited 16 months to be treated for the inflammatory auto immune disorder that was shown in my blood work. By this point my right forearm and right hand were so swollen, numbness and tingling. I began forming large dense nodules on the palms of both hands. Was then directed to a hand surgeon. Insomnia, excess sweating, nightmares and extreme daytime sleepiness, which resulted in getting a sleep study done that showed no pertinent results. Extreme weight loss, decrease appetite, which resulted in seeing my primary care doctor.  I went from 114lbs to 91lbs in a short 8 months. Ended up under the treatment of neurology due to major depression, insomnia, and sleep walking. Neurology provided me a referral for counseling.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnambulism, Somnolence, Weight decreased, X-ray
Clinical narrative: Increased swelling in my right forearm and right hand, which resulted in blood tests, specifically a RA panel that was initially reported a positive ANA factor and had to seek out Rheumatology. I waited 16 months to be treated for the inflammatory auto immune disorder that was shown in my blood work. By this point my right forearm and right hand were so swollen, numbness and tingling. I began forming large dense nodules on the palms of both hands. Was then directed to a hand surgeon. Insomnia, excess sweating, nightmares and extreme daytime sleepiness, which resulted in getting a sleep study done that showed no pertinent results. Extreme weight loss, decrease appetite, which resulted in seeing my primary care doctor.  I went from 114lbs to 91lbs in a short 8 months. Ended up under the treatment of neurology due to major depression, insomnia, and sleep walking. Neurology provided me a referral for counseling.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Malaise, Swelling
Clinical narrative: Swelling, overall unwell feeling
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: PATIENT RECEIVED SHINGRIX (3RD DOSE) INSTEAD OF PNEUMONIA-- NO REACTIONS/ADVERSE EVENTS
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Facial pain, Nasopharyngitis, Pain in jaw, Pain of skin
Clinical narrative: A few hours after the vaccine was administered my left jaw became very painful spreading to my left eye, forehead and scalp. After another few hours I took an Ibuprofen tab 200mg and these symptom gradually subsided.  It is now several days later and I'm having mild cold symptoms I expect will dissipate soon.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 75.0
Sex: F
Vaccine: HEPAB
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: Moderna Bivalent; Manufacturer: Moderna; LotNumber: AS7643e; Route: IM; BodySite: Left Arm; Dose: 5; VaxDate: 08/01/2023
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: pfizer bivalent covid; Manufacturer: pfizer; LotNumber: gk0923; Route: intramuscular; BodySite: left deltoid; Dose: booster; VaxDate: 08/09/2023
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: Prevnar; Manufacturer: Wyeth/Pfizer; LotNumber: GW7964; Route: IM; BodySite: left arm/pt states it was given in right arm; Dose: ; VaxDate: UNKNOWN
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: FLUAD; Manufacturer: seqirus; LotNumber: 371203; Route: IM; BodySite: arm; Dose: ; VaxDate: UNKNOWN
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 82.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 87.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: Pfizer 23-24 Comirnaty syr; Manufacturer: Pfizer; LotNumber: hg4629; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 09/27/2023
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 30.0
Sex: F
Vaccine: PNC20
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: Fluzone Quad 2023-2024; Manufacturer: Sanofi-Pasteur; LotNumber: U820DA; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 10/03/2023
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: Wyeth; LotNumber: gy1934; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 11/17/2023
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 92.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-