chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Muscle twitching, Musculoskeletal stiffness, Nausea, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Palpitations, Platelet count normal, Pregnancy test urine negative, Protein total, Pyrexia
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Red blood cell count decreased, Red blood cell nucleated morphology, Red cell distribution width normal, Syncope, White blood cell count increased
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Patient returned to pharmacy with more serious local injection site reaction, needing medical attention/antibiotics. I referred to PCP.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: no known adverse effects
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Oral herpes
Clinical narrative: developed cold sores and runny nose the next morning (9/30/23),  developed nasal congestion and puffy eyes  Sunday 10/1/23 evening/Monday 10/2/23 morning.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Aug2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 68 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Negative; (27Sep2023) Negative; (29Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 20Sep2023 to 25Sep2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Cerebrovascular accident, Dizziness, Headache, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: Patient came to the pharmacy on 10/03/23 to report that after she received her annual influenza vaccine on 10/01/23, she felt very dizzy, had tingling and numbness in her bottom lip and on her tongue, as well as experienced headache.  She went to urgent care where she was seen for a suspected stroke or TIA. However, she was not diagnosed with anything and was discharged home. Patient reported that she took Tylenol and feels better today.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Transient ischaemic attack
Clinical narrative: Patient came to the pharmacy on 10/03/23 to report that after she received her annual influenza vaccine on 10/01/23, she felt very dizzy, had tingling and numbness in her bottom lip and on her tongue, as well as experienced headache.  She went to urgent care where she was seen for a suspected stroke or TIA. However, she was not diagnosed with anything and was discharged home. Patient reported that she took Tylenol and feels better today.
Age: 74.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site swelling
Clinical narrative: Injection site swelled to the size of a jawbreaker. Patient reported no itching, no dizziness, no shortness of breath. Advised to apply cold compress to the site for the next few days
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash all over torso 48 hours S/P injection  Red  itchy rash on chest: abdomen: lower back  No other symptoms  No fever; no respiratory symptoms
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Allergy to vaccine, Angioedema, Dyspnoea, Full blood count normal, Histamine intolerance
Clinical narrative: 10 days after my 3rd booster. I began having symptoms of hives and shortness of breath. the hives began in my armpits and groin area. I went to urgent care and received a medrol dose pack. over the next couple days the hives spread over my whole body and I began to get angioedemia of my lips and swelling in my hands. I went to the emergency room and received albuterol and more steroids. then I followed up with my PCP, began ongoing antihistamines, diphenhydramine, loratidine, and ranitidine. I was refereed to an allergist who prescribed me an epipen, then to an oncologist for urther testing.  over the next week I developed histamine hypersensitivity (possible mastocytosis) with skin writing. the symptoms persisted and began to ween over 6 months. today I am 100% back to normal.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test normal, Metabolic function test normal, Peripheral swelling, Tryptase, Urticaria
Clinical narrative: 10 days after my 3rd booster. I began having symptoms of hives and shortness of breath. the hives began in my armpits and groin area. I went to urgent care and received a medrol dose pack. over the next couple days the hives spread over my whole body and I began to get angioedemia of my lips and swelling in my hands. I went to the emergency room and received albuterol and more steroids. then I followed up with my PCP, began ongoing antihistamines, diphenhydramine, loratidine, and ranitidine. I was refereed to an allergist who prescribed me an epipen, then to an oncologist for urther testing.  over the next week I developed histamine hypersensitivity (possible mastocytosis) with skin writing. the symptoms persisted and began to ween over 6 months. today I am 100% back to normal.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Serious pain in the arm where the vaccine was injected. Could not even lift my arm. Extreme muscle pain in my neck and shoulders all night long; in bed writhing in pain all thru the night. Constant headache all night long (I never get headaches) Nausea Generally ill feeling with low energy  (I have never experienced adverse symptoms from any other vaccine taken previously).
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Myalgia, Nausea, Neck pain
Clinical narrative: Serious pain in the arm where the vaccine was injected. Could not even lift my arm. Extreme muscle pain in my neck and shoulders all night long; in bed writhing in pain all thru the night. Constant headache all night long (I never get headaches) Nausea Generally ill feeling with low energy  (I have never experienced adverse symptoms from any other vaccine taken previously).
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Reticulocyte count abnormal
Clinical narrative: Vaccination expired 9/30/2023 and administered after expiration date on 10/3/2023.
Sex: F
Vaccine: COVID19, COVID19, FLUX, TDAP, COVID19, FLUA4, TDAP
Symptoms: Feeling hot, Headache, Injection site pain
Clinical narrative: her forehead feels a little warm; soreness on her arm at the injection site; has a little bit of a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "her forehead feels a little warm"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "soreness on her arm at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "has a little bit of a headache". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, FLUX, TDAP, COVID19, FLUA4, TDAP
Symptoms: Blood grouping, Fatigue, Feeling hot, Headache, Vaccination site pain
Clinical narrative: her forehead feels a little warm; soreness on her arm at the injection site; has a little bit of a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "her forehead feels a little warm"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "soreness on her arm at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "has a little bit of a headache". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, FLUX, TDAP, COVID19, FLUA4, TDAP
Symptoms: Fatigue, Feeling hot, Headache, Pain in extremity, Product administration error
Clinical narrative: her forehead feels a little warm; soreness on her arm at the injection site; has a little bit of a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "her forehead feels a little warm"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "soreness on her arm at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "has a little bit of a headache". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, FLUX, TDAP, COVID19, FLUA4, TDAP
Symptoms: Vaccination site pain
Clinical narrative: her forehead feels a little warm; soreness on her arm at the injection site; has a little bit of a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "her forehead feels a little warm"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "soreness on her arm at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "has a little bit of a headache". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 (Drug ineffective); COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). No known allergy. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2014, stop date: 22Sep2023. The following information was reported: COVID-19 (medically significant) with onset Sep2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Sep2023, outcome "unknown", described as "COVID 19 (Drug ineffective)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 22Sep2023 (Lot number: GK5810) to 27Sep2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose number unknown (booster), single (Lot number: GJ3277), in left arm and on 02Aug2023 as dose number unknown (booster), single (Lot number: GK0923), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure high" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 19Sep2023 to 23Sep2023.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Apr2023 as dose 3 (booster), single (Lot number: GL2042) at the age of 76 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Days 10 & 11 post treatment tested negative; (Sep2023) Positive, notes: Day 7 post treatment tested positive; (21Sep2023) Negative, notes: Covid 19 tested negative two days after completing Paxlovid/Day 12 symptoms gone. Therapeutic measures were taken as a result of drug ineffective, covid-19: treatment with Paxlovid from 14Sep2023 to 19Sep2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: already vaccinated for first and second dose but still tested positive for covid a week before his booster.; already vaccinated for first and second dose but still tested positive for covid a week before his booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "already vaccinated for first and second dose but still tested positive for covid a week before his booster.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still tested positive for covid a week before his booster.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Tachycardia
Clinical narrative: Interchange of vaccine products; a mild increase in the tachycardia; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2023NVX-US-000001185 (Novavax).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), 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 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE, in the 150's then ended up in the hospital), for COVID-19 immunisation, reaction(s): "tachycardia"; Moderna covid-19 vaccine (DOSE 2, SINGLE, had to be treated with beta blockers), for COVID-19 immunisation, reaction(s): "postural orthostatic tachycardia"; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, in the 150's then ended up in the hospital), for COVID-19 immunisation, reaction(s): "tachycardia"; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, had to be treated with beta blockers), for COVID-19 immunisation, reaction(s): "postural orthostatic tachycardia". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering"; TACHYCARDIA (medically significant), outcome "recovering", described as "a mild increase in the tachycardia". Therapeutic measures were taken as a result of tachycardia. Clinical Course: BioNTech Covid-19 vaccine, and had a mild increase in the tachycardia, but it was not as severe. It lasted for months, and then it kind of went down to baseline, but still requires beta blockers. Two years later, the patient is still on beta blockers. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect vaccine product to the reported event Tachycardia cannot be excluded. It was noted that "BioNTech Covid-19 vaccine, and had a mild increase in the tachycardia". Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pain
Clinical narrative: Continued headaches after vaccine. Chills and aches after vaccine for 24 hours.
Age: 67.0
Sex: M
Vaccine: UNK, COVID19-2
Symptoms: Blood glucose increased, Glycosylated haemoglobin normal, Therapy change
Clinical narrative: A day or 2 after the injection, my blood glucose began to rise to levels not normally experienced.  I am a well maintained type 2 diabetic, using low doses of Tresiba, and weekly Ozempic. My most recent A1c was 6.1.  My meter and Dexcom 7 registered blood glucose reading up to 240 and never lower that 150 at any time since the vaccine. I was forced to increase my level of tresiba and periodic injections of NovolinR to try and offset the glucose rise. This situation continues to be troublesome.
Age: 67.0
Sex: M
Vaccine: UNK, COVID19-2
Symptoms: Blood glucose increased, Chest discomfort, Sluggishness
Clinical narrative: A day or 2 after the injection, my blood glucose began to rise to levels not normally experienced.  I am a well maintained type 2 diabetic, using low doses of Tresiba, and weekly Ozempic. My most recent A1c was 6.1.  My meter and Dexcom 7 registered blood glucose reading up to 240 and never lower that 150 at any time since the vaccine. I was forced to increase my level of tresiba and periodic injections of NovolinR to try and offset the glucose rise. This situation continues to be troublesome.
Age: 1.83
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Chills, Pyrexia, Wrong product administered
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unappoved storage unit
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: administration error - 2 flu vaccines administered instead of 1 flu vaccine and 1 covid vaccine. No adverse events occurred due to the error.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Low fever (100.1*F), body aches, headache, injection-site pain
Age: 74.0
Sex: M
Vaccine: COVID19, FLU4, PNC20, VARZOS
Symptoms: Erythema, Malaise, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient returned to pharmacy department today complaining of severe redness and rash on his right side from the clavicle to his lower abdomen. Patient presented a photo of rash and said it was red and itchy. Patient said he had gone home after vaccinations  were administered and took a nap because he did not feel well. Patient stated he woke up to the redness and rash and tried Triamcinolone cream he had at home to stop itching but it did not resolve. Patient was looking for recommendation from pharmacist as to what he could do for rash. Pharmacist informed patient that he needed to contact his primary care physician because the rash looked severe and would need to be treated by physician. Patient understood and verbalized understanding. Patient said he would contact his primary care physician immediately.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU4, PNC20, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient returned to pharmacy department today complaining of severe redness and rash on his right side from the clavicle to his lower abdomen. Patient presented a photo of rash and said it was red and itchy. Patient said he had gone home after vaccinations  were administered and took a nap because he did not feel well. Patient stated he woke up to the redness and rash and tried Triamcinolone cream he had at home to stop itching but it did not resolve. Patient was looking for recommendation from pharmacist as to what he could do for rash. Pharmacist informed patient that he needed to contact his primary care physician because the rash looked severe and would need to be treated by physician. Patient understood and verbalized understanding. Patient said he would contact his primary care physician immediately.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Approx 10 minutes after flu vaccine, patient developed hives on face.  Parents brought back into clinic for examination.  No history of allergy to egg or previous immunizations.  Received flu vaccine as an infant.  On exam patient had several 1-3mm blanching pink wheals on both cheeks and a few on stomach.  Not itchy.  No facial swelling, tongue or lip swelling, no wheezing or cough.  Playful and active.    Administered 5mL cetirizine.  Instructed to watch closely tonight and to take to ER if worsening rash, any swelling of tongue, lips, or face, or if any wheeze, cough, shortness of breath, or vomiting.  Will refer to allergist for skin testing prior to next influenza vaccine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: patient did not show any signs or symptoms, but she did not want the moderna vaccine, she was given the vaccine in error
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the incorrect influenza for the patient's age.
Age: 90.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Pt given flu vaccine instead of covid vaccine.  Pt had already received flu vaccine. No ill effects noted.
Age: 13.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Feeling cold, Hyperhidrosis, Immediate post-injection reaction, Oropharyngeal discomfort
Clinical narrative: Immediate onset of dizziness (she felt like she almost fainted), forehead was sweaty and body felt cold, difficult to see (bright), ringing in the ears, throat felt "funny" (although she was able to breath normally and drink water). This was her second Covid booster after the initial set of two shots (she had received her last booster in Oct 2022).
Age: 13.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Presyncope, Tinnitus, Visual impairment
Clinical narrative: Immediate onset of dizziness (she felt like she almost fainted), forehead was sweaty and body felt cold, difficult to see (bright), ringing in the ears, throat felt "funny" (although she was able to breath normally and drink water). This was her second Covid booster after the initial set of two shots (she had received her last booster in Oct 2022).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity, Peripheral swelling, Swelling face
Clinical narrative: Patient stating having allergic reaction to Shingrix vaccine. Experienced redness, swelling on left arm and cheek. Went to emergency room after taking Benadryl and did not help as  symptoms got worse. At ER patient received injection that helped with swelling, only remains redness on lower area of vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema
Clinical narrative: Patient stating having allergic reaction to Shingrix vaccine. Experienced redness, swelling on left arm and cheek. Went to emergency room after taking Benadryl and did not help as  symptoms got worse. At ER patient received injection that helped with swelling, only remains redness on lower area of vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure normal, Dizziness, Electrocardiogram normal, Hypoaesthesia
Clinical narrative: Lightheaded, vomiting, passed out, tingling in fingers and toes, body numbness
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Paraesthesia, Vomiting
Clinical narrative: Lightheaded, vomiting, passed out, tingling in fingers and toes, body numbness
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Acne, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Hi it didn?t give me an option for the Johnson and Johnson vaccine thiis is what has been going on After I got the Vaccine For COVID-19 (Johnson and Johnson) 2 month?s later till this day I?ve been feeling bad after the vaccine I started having a lot of pimples and bumps on my arms, legs, and face , I?ve been getting lots a lots of headaches before I wouldn?t at all,  fatigue, and muscle aches, and feeling very tired before I wouldn?t have any of these issues.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Hi it didn?t give me an option for the Johnson and Johnson vaccine thiis is what has been going on After I got the Vaccine For COVID-19 (Johnson and Johnson) 2 month?s later till this day I?ve been feeling bad after the vaccine I started having a lot of pimples and bumps on my arms, legs, and face , I?ve been getting lots a lots of headaches before I wouldn?t at all,  fatigue, and muscle aches, and feeling very tired before I wouldn?t have any of these issues.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Hyperhidrosis, Nervousness, Tinnitus
Clinical narrative: A few hours after receiving the Covid vaccine my ears have started ringing pretty bad. I also feel very warm and was sweating pretty bad at one point. Now I feel nervous and anxious which is not helping my symptoms.        xios
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood magnesium normal, Blood test normal, Chest X-ray normal, Differential white blood cell count normal, Dyspnoea
Clinical narrative: Pounding heart, slight shortness of breath, fatigue starting around noon 10/03/2023
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram normal, Fatigue, Full blood count normal, Metabolic function test normal, Palpitations
Clinical narrative: Pounding heart, slight shortness of breath, fatigue starting around noon 10/03/2023
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin T normal, Ultrasound scan
Clinical narrative: Pounding heart, slight shortness of breath, fatigue starting around noon 10/03/2023
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Around 7:30pm the evening of 10/01/23 a large fevered welt type place started to develop. At this point it was roughly the size of a quarter. On 10/02/23 around 8:39 pm (times are confirmed with images I took of place on arm) it became a deep red and just about quadrupled in size. On top of this very painful place on my arm I was both freezing and in a cold sweat at the same time, felt like I was going to puke, had a fever, and hurt all over. Currently on 10/03/23 at 11:03 pm it has grown more and became an even darker shade of red. It is still tender and warm to the touch.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Tenderness, Urticaria
Clinical narrative: Around 7:30pm the evening of 10/01/23 a large fevered welt type place started to develop. At this point it was roughly the size of a quarter. On 10/02/23 around 8:39 pm (times are confirmed with images I took of place on arm) it became a deep red and just about quadrupled in size. On top of this very painful place on my arm I was both freezing and in a cold sweat at the same time, felt like I was going to puke, had a fever, and hurt all over. Currently on 10/03/23 at 11:03 pm it has grown more and became an even darker shade of red. It is still tender and warm to the touch.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: patient felt her throat closing and she was given hydroxyzine, steriod medication and IV fluid at the ER
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular swelling
Clinical narrative: Swollen Left testicle with pain 26 hours after vaccination
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Paraesthesia, Tinnitus
Clinical narrative: My hyperacusis Tinnitus increased after the new Pfizer Covid vaccine. Paresthesia on the forehead is happening as well; similar to the feeling of static or a foot falling asleep. This happened within the hour after receiving the new vaccine. This did not happen with any other Covid-19 Vaccination. No new medications or routine- only the Vaccination at 3:40PM
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: patients received FluLaval QIV today after a temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 39PF2, expiry date 30-JUN-2024) for prophylaxis.   On 25-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: patients received FluLaval QIV today after a temperature excursion).  The outcome of the incorrect storage of drug 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: 25-Sept-2023 Doctor of medicine called and reported that 6 patients received FluLaval QIV on the day of reporting after a temperature excursion (total time of excursion was 112 hours). The reporter had no details regarding patients but gave consent for follow up. This is 1 of 6 linked patients reported by the same reporter. The patient received a dose of Flulaval QIV after temperature excursion, which led to incorrect storage of drug.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Illness
Clinical narrative: Her entire body turned red with flushing; Her entire body turned red with flushing; she was very very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Her entire body turned red with flushing), FLUSHING (Her entire body turned red with flushing) and ILLNESS (she was very very sick) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Quadriplegia.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Her entire body turned red with flushing), FLUSHING (Her entire body turned red with flushing) and ILLNESS (she was very very sick). At the time of the report, ERYTHEMA (Her entire body turned red with flushing), FLUSHING (Her entire body turned red with flushing) and ILLNESS (she was very very sick) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had previous Moderna vaccines which caused severe reactions and she doesn't want to take any more Moderna. Treatment information was not reported.