chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's father reported to medical clinic with his son. 6yo male was vaccinated with flu shot on 29OCT2024. And father of patient reports that he has noticed the swelling on the left deltoid on 30OCT2024. Assessed patient's left deltoid where the flu shot was administered.  Apparent redness and swelling warm to touch are present. The size of the measurement of the swelling is the width of 3.5cm and the length of 2.5cm. Patient denies pain, having shortness of breath, angioedema, and hives.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site nodule
Clinical narrative: Mobile Nodules above/below injection site, self limited and resolved, no hives, no infectious site, no anaphylaxis, no angioedema
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient presented with no swelling, mild pain, and 3x3 rash in deltoid region of arm where patient had received the two vaccines. Patient said rash got worse and came in to show us 4 days after her shot (shot 10/26/24) shown rash 10/30/24. Patient said no hives or sob. Patient said rash is responding well to ice and apap and benadryl.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test, Dizziness, Full blood count, Headache, Influenza virus test
Clinical narrative: 10-11-24  Nervous/panic attack then started the aching all over, extreme headache and fever up to 101.4 for 7 days
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nervousness, Pain, Panic attack, Pyrexia
Clinical narrative: 10-11-24  Nervous/panic attack then started the aching all over, extreme headache and fever up to 101.4 for 7 days
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory syncytial virus test, Rheumatoid factor, SARS-CoV-2 test, Streptococcus test, Urine analysis
Clinical narrative: 10-11-24  Nervous/panic attack then started the aching all over, extreme headache and fever up to 101.4 for 7 days
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra MMR vaccine. Patient's mother stated patient has had no adverse reaction
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: Hives on left arm and right wrist, swollen lymph node in the left armpit
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Muscle swelling, Muscle tightness, Pain in extremity, Skin warm, Sleep disorder
Clinical narrative: Patient came into the pharmacy on 10/30/24 stating their arm hurt, when asked if it was warm to the touch they stated no. Patient stated that they are unable to sleep on left side, swelling and hardening of the muscle (stiff)
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Fatigue, Lethargy, Vomiting
Clinical narrative: Meningitis Vaccine ? has been vomiting on average 2-3 times per day for7 days.  Very weak, fatigued and lethargic.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head abnormal, Herpes zoster, Post herpetic neuralgia
Clinical narrative: Bells Palsy/ Shingles/Postherpetic neuralgia (PHN) left side face/ear/neck
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 10/28/2024 it was noted that the resident has a red, swollen are area on his right arm in the area of his COVID vaccination. The area measured 16.5 cm vertically and 17 cm horizontally. Resident was afebrille and did not report pain. On 10/29 the area on resident's right arm had spread outside of the initial area noted on 10/28. The resident reported no pain or discomfort. Resident is on scheduled Tylenol. The resident's providor was notified on the redness spreading. Provider ordered Doxycycline 100 mg BID for 7 days and Cetirizine 10 mg once a day. On 10/30, the facility's medical director assessed the site and concluded that the area looked to be a reaction to the COVID vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number D252F, expiry date 04-OCT-2027) for prophylaxis.   On 18-OCT-2024, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Administration after 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: 21-OCT-2024 The caller reported that their fridge had a temperature excursion, so called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered. The HCP mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix HCP reported to administer this vaccines to 13 different patients, the info for all of the patients can be found in the Description area for the case which eld to incorrect storage of drug. The HCP mentioned that all of this patients received the vaccines in 18 October 2024. This was 1 of the 14 cases, reported by the same reporter.
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Blister, Lip swelling, Rash, Swelling face
Clinical narrative: On August 26, 2024, I received a flu vaccination. Fluzone High-Dose 0.5 ML INJ SANO NDC 49281-0124-65 Two days later, I started to get symptoms which resembled a major allergic reaction or a viral infection. The right side of my face started to swell up, and many sores similar to Herpes Simplex l appeared on my face. There were more of these sores on the right side of my face than on the left side. I had a childhood Herpes Simplex l infection, but nothing like this has ever happened before. I treated the condition with Ibuprofen, Claritin, and topical Betadine. It got worse. On September 3, 2024, my doctor prescribed predniSONE 10 MG TAB HIKM. This caused a great reduction in the swelling. Over the next few weeks, the sores healed. Minor scarring remains.===== I believe that the flu vaccination caused a major immune reaction, and may have activated a latent viral infection. I have had previous flu vaccinations, perhaps 20 times. Nothing like this has ever happened before. I suspect that the vaccine contains a novel adjuvant or has been reformulated. I would be very interested in getting information about exactly how this vaccine was manufactured.
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Scar, Skin lesion, Swelling face
Clinical narrative: On August 26, 2024, I received a flu vaccination. Fluzone High-Dose 0.5 ML INJ SANO NDC 49281-0124-65 Two days later, I started to get symptoms which resembled a major allergic reaction or a viral infection. The right side of my face started to swell up, and many sores similar to Herpes Simplex l appeared on my face. There were more of these sores on the right side of my face than on the left side. I had a childhood Herpes Simplex l infection, but nothing like this has ever happened before. I treated the condition with Ibuprofen, Claritin, and topical Betadine. It got worse. On September 3, 2024, my doctor prescribed predniSONE 10 MG TAB HIKM. This caused a great reduction in the swelling. Over the next few weeks, the sores healed. Minor scarring remains.===== I believe that the flu vaccination caused a major immune reaction, and may have activated a latent viral infection. I have had previous flu vaccinations, perhaps 20 times. Nothing like this has ever happened before. I suspect that the vaccine contains a novel adjuvant or has been reformulated. I would be very interested in getting information about exactly how this vaccine was manufactured.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a patient over the age of 45 year old was given the GARDASIL 9 vaccine; No additional AE/PQC reported.; This spontaneous report has been received from a consumer via company representative, regarding a female patient of unknown age (reported as over 45-year-old). The patient's previous allergies, medical history, concurrent conditions, and concomitant medications were not provided.      On unspecified date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, (strength, dose, frequency, route of administration, vaccination scheme, site of vaccination, lot #, and expiration date were not reported) as a prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: F
Vaccine: COVID19, TD
Symptoms: Atrophy, Influenza like illness, Injected limb mobility decreased, Muscular weakness, Overdose
Clinical narrative: Dose: 0.5 mL; atrophied to lost full mobility of right upper arm to wrist; atrophied to lost full mobility of right upper arm to wrist; cannot carry and hold anything and has lowered; flu like sickness; arm has just started to subside from the pain/pain did not start until almost a week after shots; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2023SA294794 (Sanofi), AE-016224 (BioNTech SE).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13May2024 as dose 1, 0.5 ml single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; diphtheria vaccine toxoid, tetanus vaccine toxoid (TENIVAC), on 13May2024 as dose 1, 0.5 ml single) intramuscular for immunisation. The patient's relevant medical history included: "Glucose tolerance impaired" (ongoing); "Fibromyalgia" (ongoing); "Food allergy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: OVERDOSE (non-serious) with onset 13May2024, outcome "unknown", described as "Dose: 0.5 mL"; VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "recovering", described as "arm has just started to subside from the pain/pain did not start until almost a week after shots"; ATROPHY (disability), INJECTED LIMB MOBILITY DECREASED (disability) all with onset 2024, outcome "unknown" and all described as "atrophied to lost full mobility of right upper arm to wrist"; MUSCULAR WEAKNESS (disability) with onset 2024, outcome "unknown", described as "cannot carry and hold anything and has lowered"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "flu like sickness".  Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 omi xbb.1.5 is under agreement with BIONTECH SE.
Sex: F
Vaccine: COVID19, TD
Symptoms: Vaccination site pain
Clinical narrative: Dose: 0.5 mL; atrophied to lost full mobility of right upper arm to wrist; atrophied to lost full mobility of right upper arm to wrist; cannot carry and hold anything and has lowered; flu like sickness; arm has just started to subside from the pain/pain did not start until almost a week after shots; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2023SA294794 (Sanofi), AE-016224 (BioNTech SE).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13May2024 as dose 1, 0.5 ml single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; diphtheria vaccine toxoid, tetanus vaccine toxoid (TENIVAC), on 13May2024 as dose 1, 0.5 ml single) intramuscular for immunisation. The patient's relevant medical history included: "Glucose tolerance impaired" (ongoing); "Fibromyalgia" (ongoing); "Food allergy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: OVERDOSE (non-serious) with onset 13May2024, outcome "unknown", described as "Dose: 0.5 mL"; VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "recovering", described as "arm has just started to subside from the pain/pain did not start until almost a week after shots"; ATROPHY (disability), INJECTED LIMB MOBILITY DECREASED (disability) all with onset 2024, outcome "unknown" and all described as "atrophied to lost full mobility of right upper arm to wrist"; MUSCULAR WEAKNESS (disability) with onset 2024, outcome "unknown", described as "cannot carry and hold anything and has lowered"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "flu like sickness".  Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 omi xbb.1.5 is under agreement with BIONTECH SE.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Bronchitis
Clinical narrative: Same
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Syncope
Clinical narrative: Nausea; Fever; Fainted; This serious case was reported by a consumer and described the occurrence of fainting in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-SEP-2024, the patient received Shingrix .5 ml. On 15-SEP-2024, 5 days after receiving Shingrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant). On 18-SEP-2024, the patient experienced fever (Verbatim: Fever). On 02-OCT-2024, the patient experienced nausea (Verbatim: Nausea). On 15-SEP-2024, the outcome of the fainting was resolved.  On 30-SEP-2024, the outcome of the fever was resolved (duration 12 days). The outcome of the nausea was resolving.   It was unknown if the reporter considered the fainting, fever and nausea to be related to Shingrix.     The company considered the fainting to be unrelated to Shingrix. It was unknown if the company considered the fever and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2024  The patient self-reported this case for himself. The patient received Shingrix. The patient had Nausea, fainted and fever. The patient reported that the symptoms were treated.; Sender's Comments: Syncope is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shot and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the shot and still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-OCT-2024 This case was reported by a patient via interactive digital media. The patient stated that the vaccine was only 90 percent effective. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient  details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Dizziness, Dyskinesia, Feeling cold
Clinical narrative: 20 hours after shot,  light headed, fainted, vomited. Drank a little juice, applied cold packs. Went back to bed. Slept for 3 hours. Woke up, drank some water, V-8. Rested about half an hour. Started feeling cold, shaky, shivering, teeth chattering, writhing, crying, head aching. Three blankets, two heating pads, one large dog. Finally warmed up and relaxed after about 45 minutes to an hour. Drank some water, ginger ale. Rested about an hour. No nausea, but suddenly vomited 5 or 6 times. Rested with occasional chills about 4 hours. Ate bread, water, ginger ale. Slept. Two days later, 8-10 cold sores on lower lip, right nostril swollen and painful, tongue sores.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nervousness, Oral herpes, Rhinalgia, Swelling
Clinical narrative: 20 hours after shot,  light headed, fainted, vomited. Drank a little juice, applied cold packs. Went back to bed. Slept for 3 hours. Woke up, drank some water, V-8. Rested about half an hour. Started feeling cold, shaky, shivering, teeth chattering, writhing, crying, head aching. Three blankets, two heating pads, one large dog. Finally warmed up and relaxed after about 45 minutes to an hour. Drank some water, ginger ale. Rested about an hour. No nausea, but suddenly vomited 5 or 6 times. Rested with occasional chills about 4 hours. Ate bread, water, ginger ale. Slept. Two days later, 8-10 cold sores on lower lip, right nostril swollen and painful, tongue sores.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tongue ulceration, Vomiting
Clinical narrative: 20 hours after shot,  light headed, fainted, vomited. Drank a little juice, applied cold packs. Went back to bed. Slept for 3 hours. Woke up, drank some water, V-8. Rested about half an hour. Started feeling cold, shaky, shivering, teeth chattering, writhing, crying, head aching. Three blankets, two heating pads, one large dog. Finally warmed up and relaxed after about 45 minutes to an hour. Drank some water, ginger ale. Rested about an hour. No nausea, but suddenly vomited 5 or 6 times. Rested with occasional chills about 4 hours. Ate bread, water, ginger ale. Slept. Two days later, 8-10 cold sores on lower lip, right nostril swollen and painful, tongue sores.
Age: 1.58
Sex: F
Vaccine: FLU3
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Needle is not luer locking correctly to pre-filled syringes. Vaccine squired out of the side of syringe upon administration. Patient was given another dose given because it was leaking out of the side of syringe.
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Angioedema, Drug hypersensitivity, Lip swelling, Mouth swelling
Clinical narrative: 10002424---ANGIOEDEMA^ 10037844---RASH^ 10046735---URTICARIA This is a 67 y/o F with a PMH significant for HTN, DM2, HLD, and hypothyroidism. Patient received a Tdap vaccine for preventative care. One day following the Tdap injection the patient notified the facility after developing a rash, intense itching and sudden lip swelling. Patient was directed to go to the nearest emergency department where she received steroids, Benadryl and Epi. While at the ED, patient was told to hold their Lisinopril (been on Lisinopril 40mg since 2022) until instructed further. Patient presented the following day to the ED stating that the swelling in the mouth had gotten better but continued to have hives and swelling in the neck. Patient was given IV Benadryl, Epi, and Solumedrol at ED. Patient was admitted and discharged within 24 hours after showing improvement of symptoms. Etiology behind the reaction is unknown; therefore, each medication was listed as an allergy and will not be used again. Upon follow-up patient signs/symptoms slowly improved over the next month and is now doing well.
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: 10002424---ANGIOEDEMA^ 10037844---RASH^ 10046735---URTICARIA This is a 67 y/o F with a PMH significant for HTN, DM2, HLD, and hypothyroidism. Patient received a Tdap vaccine for preventative care. One day following the Tdap injection the patient notified the facility after developing a rash, intense itching and sudden lip swelling. Patient was directed to go to the nearest emergency department where she received steroids, Benadryl and Epi. While at the ED, patient was told to hold their Lisinopril (been on Lisinopril 40mg since 2022) until instructed further. Patient presented the following day to the ED stating that the swelling in the mouth had gotten better but continued to have hives and swelling in the neck. Patient was given IV Benadryl, Epi, and Solumedrol at ED. Patient was admitted and discharged within 24 hours after showing improvement of symptoms. Etiology behind the reaction is unknown; therefore, each medication was listed as an allergy and will not be used again. Upon follow-up patient signs/symptoms slowly improved over the next month and is now doing well.
Age: 2.17
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Flulaval medication came out of the side of the syringe and none was administered to the patient. (There was leakage at the connection of the needle and syringe.) Mom refused second shot to receive vaccine.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: indication-ankylosing spondylitis of unspecified sites in spine, chronic iridocyclitis, bilateral. patient reported hives when administering enbrel that last 6 days. patient received the pneumovax 23 vaccine and had an anaphylaxis reaction that lasted about a week and hospitalized for 2 weeks. dates not provided. md will be notified. no further information provided.
Sex: M
Vaccine: COVID19
Symptoms: Anion gap increased, Asthenia, Blood creatinine increased, Confusional state, Decreased appetite
Clinical narrative: 10010300---CONFUSION^ 10011375---CREATININE SERUM INCREASED^ 10013573---DIZZINESS^ 10016256---FATIGUE^ 10019211---HEADACHE^ 10047700---VOMITING^ 10047900---WEIGHT LOSS^ 10061428---DECREASED APPETITE^ 10062237---RENAL IMPAIRMENT^ 10069033---HIGH ANION GAP METABOLIC ACIDOSIS Patient is a 74 year old male with PMH significant for T2D, HLD, HTN, and BPH. Patient was seen at clinic on 5/15/2024 for review of routine labs. At this visit the provider changed the patient's statin from Pravastatin to Rosuvastatin 10mg daily, started on Metformin 500mg ER daily and Empagliflozin 10 mg daily for A1C 8.5%. Patient has history of asymptomatic hypokalemia and was on potassium supplementation 10meq daily. Patient also received Moderna Monovalent Spikevax vaccine on 5/15/24. A week later, on 5/21/24, patient presented to ED with complaints of headaches, body aches, confusion, weakness, lightheadedness, and fatigue. Patient reported decreased appetite and weight loss approximately 10lbs in the last month, with his last normal meal 3 days ago. Patient denied alcohol use. Providers obtained labs and suspected euglycemic diabetic ketoacidosis (DKA). Metformin and empagliflozin were held and patient was admitted to the ICU. The patient was treated first with fluids and electrolyte replacement before starting an insulin infusion. The insulin infusion ran for 6 hours until the anion gap was resolved and within 3 days of stopping SGL T2i, patient's symptoms improved. Once the IV insulin was discontinued, patient was downgraded to regular medicine floor. Upon discharge on 5/26/2024, empagliflozin and metformin were discontinued, and patient was started on basal and bolus insulin. Patient was educated on diet, hypoglycemia, insulin dosing, and emergency room precautions. 10010300---CONFUSION^ 10011375---CREATININE SERUM INCREASED^ 10013573---DIZZINESS^ 10016256---FATIGUE^ 10019211---HEADACHE^ 10047700---VOMITING^ 10047900---WEIGHT LOSS^ 10061428---DECREASED APPETITE^ 10062237---RENAL IMPAIRMENT^ 10069033---HIGH ANION GAP METABOLIC ACIDOSIS
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Euglycaemic diabetic ketoacidosis, Fatigue, Headache, Intensive care
Clinical narrative: 10010300---CONFUSION^ 10011375---CREATININE SERUM INCREASED^ 10013573---DIZZINESS^ 10016256---FATIGUE^ 10019211---HEADACHE^ 10047700---VOMITING^ 10047900---WEIGHT LOSS^ 10061428---DECREASED APPETITE^ 10062237---RENAL IMPAIRMENT^ 10069033---HIGH ANION GAP METABOLIC ACIDOSIS Patient is a 74 year old male with PMH significant for T2D, HLD, HTN, and BPH. Patient was seen at clinic on 5/15/2024 for review of routine labs. At this visit the provider changed the patient's statin from Pravastatin to Rosuvastatin 10mg daily, started on Metformin 500mg ER daily and Empagliflozin 10 mg daily for A1C 8.5%. Patient has history of asymptomatic hypokalemia and was on potassium supplementation 10meq daily. Patient also received Moderna Monovalent Spikevax vaccine on 5/15/24. A week later, on 5/21/24, patient presented to ED with complaints of headaches, body aches, confusion, weakness, lightheadedness, and fatigue. Patient reported decreased appetite and weight loss approximately 10lbs in the last month, with his last normal meal 3 days ago. Patient denied alcohol use. Providers obtained labs and suspected euglycemic diabetic ketoacidosis (DKA). Metformin and empagliflozin were held and patient was admitted to the ICU. The patient was treated first with fluids and electrolyte replacement before starting an insulin infusion. The insulin infusion ran for 6 hours until the anion gap was resolved and within 3 days of stopping SGL T2i, patient's symptoms improved. Once the IV insulin was discontinued, patient was downgraded to regular medicine floor. Upon discharge on 5/26/2024, empagliflozin and metformin were discontinued, and patient was started on basal and bolus insulin. Patient was educated on diet, hypoglycemia, insulin dosing, and emergency room precautions. 10010300---CONFUSION^ 10011375---CREATININE SERUM INCREASED^ 10013573---DIZZINESS^ 10016256---FATIGUE^ 10019211---HEADACHE^ 10047700---VOMITING^ 10047900---WEIGHT LOSS^ 10061428---DECREASED APPETITE^ 10062237---RENAL IMPAIRMENT^ 10069033---HIGH ANION GAP METABOLIC ACIDOSIS
Sex: M
Vaccine: COVID19
Symptoms: Metabolic acidosis, Pain, Renal impairment, Vomiting, Weight decreased
Clinical narrative: 10010300---CONFUSION^ 10011375---CREATININE SERUM INCREASED^ 10013573---DIZZINESS^ 10016256---FATIGUE^ 10019211---HEADACHE^ 10047700---VOMITING^ 10047900---WEIGHT LOSS^ 10061428---DECREASED APPETITE^ 10062237---RENAL IMPAIRMENT^ 10069033---HIGH ANION GAP METABOLIC ACIDOSIS Patient is a 74 year old male with PMH significant for T2D, HLD, HTN, and BPH. Patient was seen at clinic on 5/15/2024 for review of routine labs. At this visit the provider changed the patient's statin from Pravastatin to Rosuvastatin 10mg daily, started on Metformin 500mg ER daily and Empagliflozin 10 mg daily for A1C 8.5%. Patient has history of asymptomatic hypokalemia and was on potassium supplementation 10meq daily. Patient also received Moderna Monovalent Spikevax vaccine on 5/15/24. A week later, on 5/21/24, patient presented to ED with complaints of headaches, body aches, confusion, weakness, lightheadedness, and fatigue. Patient reported decreased appetite and weight loss approximately 10lbs in the last month, with his last normal meal 3 days ago. Patient denied alcohol use. Providers obtained labs and suspected euglycemic diabetic ketoacidosis (DKA). Metformin and empagliflozin were held and patient was admitted to the ICU. The patient was treated first with fluids and electrolyte replacement before starting an insulin infusion. The insulin infusion ran for 6 hours until the anion gap was resolved and within 3 days of stopping SGL T2i, patient's symptoms improved. Once the IV insulin was discontinued, patient was downgraded to regular medicine floor. Upon discharge on 5/26/2024, empagliflozin and metformin were discontinued, and patient was started on basal and bolus insulin. Patient was educated on diet, hypoglycemia, insulin dosing, and emergency room precautions. 10010300---CONFUSION^ 10011375---CREATININE SERUM INCREASED^ 10013573---DIZZINESS^ 10016256---FATIGUE^ 10019211---HEADACHE^ 10047700---VOMITING^ 10047900---WEIGHT LOSS^ 10061428---DECREASED APPETITE^ 10062237---RENAL IMPAIRMENT^ 10069033---HIGH ANION GAP METABOLIC ACIDOSIS
Age: 36.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: Patient asymptomatic.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Headache, Lethargy, Nausea
Clinical narrative: Fever, body aches, lethargy, low back pain, headache, nausea, weakness
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches, lethargy, low back pain, headache, nausea, weakness
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Epistaxis, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: Patient received shots and we were discussing patient needing to sit for 15 minutes in case of allergic reaction. Confirmed to patient that I could not force him to stay but it was my recommendation. Patient agreed after a short discussion. As patient turned to walk away to sit on the bench in front of the pharmacy he passed out and hit his head against the wall. He then slid to the floor. I and patient's girlfriend rolled the patient over as his body was contorted. We propped the patient's head on a rolled up floor mat. Patient began to wake up fairly quickly as I was cleaning some blood off of his nose. We waited for EMS. Patient's blood pressure was (I believe) 124/78. EMS recommended going to the hospital. After taking a few sips of water patient began to feel nauseous and agreed to get check out at the hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm, Swelling face
Clinical narrative: SWOLLING FACE AND HOT RED AND SWOLLING RIGHT ARM
Age: 59.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Joint swelling, Pain, Pain in extremity
Clinical narrative: 10 days after vaccination, developed swollen left knee joint after waking up.  Pain in left knee (same side of body as vaccination in left arm), swollen joint, and pain radiating down outside left calf below left knee joint.   I have not experienced this type of event in the last 10-20 years.    note that I do not which flu shot that I received when I was vaccinated for both COVID & the Flu.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Blood glucose normal, Loss of consciousness, Nervousness
Clinical narrative: Received Gardasil 9, pt was nervous. Tensed up, then loss of consciousness for about 20 seconds. Came to quickly after that.  Blood glucose and blood pressure were measured as normal after he woke, and he ate and drank and was observed in clinic for at least 30mins before being walked out of clinic with parent.  No lingering effects.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia
Clinical narrative: SPIKED FEVER OF 104.5. SENT TO ER AND LATER ADMITTED TO THE HOSPITAL WITH DOUBLE PNEUMONIA.
Age: 50.0
Sex: M
Vaccine: COVID19, TDAP, TDAP
Symptoms: Extra dose administered
Clinical narrative: The patient is not reporting any sx currently but we wanted to report due to documentation and communication errors the patient received 2, 0.5 mL doses of Tdap Adacel in his arm on the same day within the same hour. The patient was told what he was receiving but the first vaccine was not documented and the provider asked for another nurse to give the Tdap and the patient reported that he got a flu vaccine first so the second nurse gave the Tdap again. She then realized after speaking with the first nurse that Tdap was actually given
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested a flu vaccine and stated she had not had the flu vaccine yet. After receiving the high dose flu vaccine the patient asked me to review her chart and see what vaccine she received recently. On review it was seen that she had received a high dose flu vaccine 2 weeks prior (10/10/2024). The incident was immediately reported to the PCP and she advised her of the possibility of side effects. Patient did not have any adverse reaction while in clinic.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received flucelvax vaccine a second time.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Lip swelling, Pruritus
Clinical narrative: On 10/29 the Vaccine was given at 9:28 am, and at 2:00 -3:00 PM developed a lot of itching in the eyes and skin. Lips slightly swollen.  The next morning the symptoms were resolving but the itching was still present.   Feeling better by the late afternoon.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain
Clinical narrative: redness and warm at injection site, body aches, tiredness. effects lasts from sunday and still present when pt came to the pharmacy Tuesday 10/30. pharmacist advised patient to apply cold pack
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Fever and malaise, body aches.  Temp 103F.  Treatment ibuprofen, fluids, rest.  Lasted 3 days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Hypoaesthesia, Neurological symptom, Oropharyngeal discomfort, Paraesthesia
Clinical narrative: 2205 right side of face and right arm began tingling and feeling numb. Throat felt ?weird? but not closed.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Scan with contrast normal, Troponin normal
Clinical narrative: 2205 right side of face and right arm began tingling and feeling numb. Throat felt ?weird? but not closed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Rash erythematous, Rash papular
Clinical narrative: Patient appeared shortly after receiving vaccine with complaints of itching, rash, and swelling near injection site. About a 2x2 raised, red rash was under the injection site (not correlated to the adhesive bandage). Patient was given benadryl 25mg liquid PO and observed. Symptoms resolved by the time the clinic was over (about 2 hours later).
Age: 70.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Throat tightness
Clinical narrative: Patient came back to clinic stating she had some throat tightness after receiving vaccines. No local reaction. She had already taken her albuterol inhaler because sometimes she feels that way from anxiety but was still feeling tightness. She was not showing any other symptoms of anaphylaxis (difficulty breathing, tongue/mouth swelling, itching, etc). She took benadryl 25mg liquid PO as a precaution and observed. When we left the clinic about 2 hours later, she reported all symptoms resolved.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given >12 year old vaccine instead of infant dose
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blindness, Crying, Dyspnoea, Hyperhidrosis, Lethargy
Clinical narrative: Patient was apprehensive to get the vaccine in the first place. His anxiety was causing him to hyperventilate prior to receiving the vaccine. Once I was able to calm him down enough to enter the vaccine, he was compliant and realized it wasn't that bad. After one minute, he started sweating and breathing heavy saying that he couldn't see. I advised him to close his eyes and lean his head against the wall and breath slowly. He continued his rapid breathing. After another minute, his eyes closed and his face was pale. At that time, I grabbed an ammonia wipe from the cabinet, opened it and rubbed it across his nose. He did open his eyes for a second and then shut them again. I repeated this process a few times before I went to get the doctor. Once provider entered the room, I handed her a fresh ammonia wipe, and she continued to rouse the patient awake while using the ammonia wipe under his nose. After about 5 minutes, he began to wake up. He was very lethargic and was moaning. After a few more minutes the patient began to have color in his face again. I asked him if he was ok, he said yes then began to cry stating that he was sorry. We gave him a popsicle and advised him to  sit and relax for about 5-10 minutes. After about 5 minutes he was standing. I asked if he felt ok or he felt light-headed, and he stated he was ok that he was just sorry. Patient and mother were confident that he felt better and was ok to leave the premises.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Moaning, Pallor
Clinical narrative: Patient was apprehensive to get the vaccine in the first place. His anxiety was causing him to hyperventilate prior to receiving the vaccine. Once I was able to calm him down enough to enter the vaccine, he was compliant and realized it wasn't that bad. After one minute, he started sweating and breathing heavy saying that he couldn't see. I advised him to close his eyes and lean his head against the wall and breath slowly. He continued his rapid breathing. After another minute, his eyes closed and his face was pale. At that time, I grabbed an ammonia wipe from the cabinet, opened it and rubbed it across his nose. He did open his eyes for a second and then shut them again. I repeated this process a few times before I went to get the doctor. Once provider entered the room, I handed her a fresh ammonia wipe, and she continued to rouse the patient awake while using the ammonia wipe under his nose. After about 5 minutes, he began to wake up. He was very lethargic and was moaning. After a few more minutes the patient began to have color in his face again. I asked him if he was ok, he said yes then began to cry stating that he was sorry. We gave him a popsicle and advised him to  sit and relax for about 5-10 minutes. After about 5 minutes he was standing. I asked if he felt ok or he felt light-headed, and he stated he was ok that he was just sorry. Patient and mother were confident that he felt better and was ok to leave the premises.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash macular, Rash papular, Skin warm, Urticaria
Clinical narrative: PTs cheeks red/hot, hives all over body, non raised splotchy rash, itchy as soon as patient got into car after leaving office
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incontinence, Mental status changes, Pyrexia, Rash, Rash erythematous
Clinical narrative: Red, hot, blistered rash to chest/neck/back, incontinence, possible stroke, altered mental status, fever.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Rash vesicular, Skin warm
Clinical narrative: Red, hot, blistered rash to chest/neck/back, incontinence, possible stroke, altered mental status, fever.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient unknowingly given 2nd RSV vaccine in response to prescription written by patient's primary care physician, outside of guidelines. Patient received first RSV vaccination on 11/03/24, which was only discovered when going to report the current vaccination to the state immunization registry.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Axillary pain, Back pain, Breast pain, Mobility decreased
Clinical narrative: Pain in right shoulder that radiates down under my arm into my armpit and around the front to my right side of my breast and to my shoulder blade in back. The pain gets to the point to where I can no longer raise my arm up or pick up any object no matter how small or large. I have never had this reaction before. Yeah a sore arm from the shot for a day or two but this pain has been going on for a month now and is not getting any better.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in right shoulder that radiates down under my arm into my armpit and around the front to my right side of my breast and to my shoulder blade in back. The pain gets to the point to where I can no longer raise my arm up or pick up any object no matter how small or large. I have never had this reaction before. Yeah a sore arm from the shot for a day or two but this pain has been going on for a month now and is not getting any better.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received adult dose instead of pediatric. No adverse events occurred.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Within 4 hours I started having pain and swelling, Slight fever and just pain over all arm. States Covid-19 test was negative. I am in good health and it was a diffcult event
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: post menopausal vaginal spotting 27 days after Pfizer COVID vaccine
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Area around shot area was red (4 inches by 4 inches) with raised margin
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Employee developed itchy skin rash. Took antihistamine and rash cleared within 24 hours.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE, REDNESS AND A KNOT.  RECOMMENDED EMPLOYEE GO TO WALK IN CLINIC BEFORE END OF WORK DAY.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Cerebral atrophy, Cerebral disorder, Chills, Electroencephalogram abnormal
Clinical narrative: Patient presented to ED on 4/25/24 with seizure activity described as rhythmic full body episode. Mother reports it looked like he had the chills and then was stiff. This happened twice within about 1 hour. After these episodes he was screaming like his was scared and was not acting normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Musculoskeletal stiffness, Screaming, Seizure
Clinical narrative: Patient presented to ED on 4/25/24 with seizure activity described as rhythmic full body episode. Mother reports it looked like he had the chills and then was stiff. This happened twice within about 1 hour. After these episodes he was screaming like his was scared and was not acting normal.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Watery Diarrhea
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus suddenly started in the middle of the night
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever. Pt presented to MD 10/28/2024. MD was not able to verify if fever was related to vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pharyngeal swelling, Throat irritation
Clinical narrative: throat swelling and itching, right hand and forearm numbness
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Feeding disorder, Headache, Mobility decreased, Myalgia, Retching
Clinical narrative: Vomiting, dry heaves, severe headache, muscle aches, extreme sleepiness.  Was in bed for over 1 1/2 days. Could not eat or drink on first day, sucked on ice chips day 2 until I started feeling slightly better late in the day.  Worse than any case of flu I can remember!  Never had such a severe reaction to flu shots before - usually just mild flu-like symptoms for a day.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence, Vomiting
Clinical narrative: Vomiting, dry heaves, severe headache, muscle aches, extreme sleepiness.  Was in bed for over 1 1/2 days. Could not eat or drink on first day, sucked on ice chips day 2 until I started feeling slightly better late in the day.  Worse than any case of flu I can remember!  Never had such a severe reaction to flu shots before - usually just mild flu-like symptoms for a day.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Mild localized vaccine reaction
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Flu shot in left arm.  Very painful with initial injection. Felt like it hit bone.  Could not move arm for about 4 days afterwards-started 2-3 hours after injection.  Denies n/t. A little improvement with pain in left arm. Denies fevers or redness. No bruising or swelling. Patient re-evaluated on 10/31/24 for SIRVA. Ultrasound placed.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY FOR A FLU SHOT STATING THEY WERE IN NEED OF 1 FOR THIS SEASON.  A FLU SHOT WAS GIVEN AND UPON PROCESSING HER PAPERWORK, IT WAS DETERMINED THAT SHE HAD ALREADY RECEIVED A FLU SHOT ON 9/25/24
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Diarrhoea, Influenza A virus test negative, Influenza B virus test negative, Lymphadenopathy
Clinical narrative: Patient was scheduled to receive a child influenza vaccine, but was mistakenly given an adult COVID-19 vaccine instead.  The patient's legal guardian and DCF caseworker were immediately notified and made aware. The next day (10/17/2024) the patient experienced several bouts of incontinent diarrhea, and 3 days later (10/19/24)  began spiking fevers (101F - 103F). The fevers persisted past 10/23/24, when he was evaluated for the second time at our clinic. On exam, cervical lymphadenopathy was noted, symptoms were treated with acetaminophen with negative COVID-19 and influenza A+B swabs.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Patient was scheduled to receive a child influenza vaccine, but was mistakenly given an adult COVID-19 vaccine instead.  The patient's legal guardian and DCF caseworker were immediately notified and made aware. The next day (10/17/2024) the patient experienced several bouts of incontinent diarrhea, and 3 days later (10/19/24)  began spiking fevers (101F - 103F). The fevers persisted past 10/23/24, when he was evaluated for the second time at our clinic. On exam, cervical lymphadenopathy was noted, symptoms were treated with acetaminophen with negative COVID-19 and influenza A+B swabs.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pruritus, Urticaria
Clinical narrative: STATES THE DAY FOLLOWING THE INJECTION SHE BEGAN HAVING FULL BODY HIVES, ITCHING, AND WEAKNESS.  STATE SHE WAS SEEN BY HER PERSONAL MD AND GIVEN ATARAX.  STATES SHE CONTINUES TO HAVE ITCHING AND HEADACHES.  REPORTS THIS WAS HER FIRST EVER FLU VACCINE.  DID NOT INITIALLY DISCLOSE ANY ALLERGIES, BUT UPON FURTHER QUESTIONING-STATES SHE HAS HAD ITCHING/HIVES/SKIN BREAKOUT WITH USE OF NEOSPORIN IN THE PAST.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient's parent(father) was notified that the incorrect Covid vaccine was given.  Teammate assured dad that she did consult the doctor about the incorrect vaccine given (higher dosage) and that the patient might have soreness in arm and mild symptoms. Patient's father did state she was doing well, and he appreciated the call to let him know about what happen. No adverse reaction occurred.
Age: 38.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received the Yellow Fever vaccine on 10/22/24 in the Clinic. He noted yesterday that the upper arm surrounding the injection site was red, swollen and painful. The swelling and redness has continued to spread down his arm.  He notes that the skin above his elbow has folded over. There is some slight streaking associated with the redness. He denies fever. Yesterday he did reach out to the ID provider on-call who will be evaluating the patient today, 10/31/2024, at noon.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Fatigue, Headache, Heart rate increased, Pain
Clinical narrative: Fever,  rapid heart beat,  dizzy, tired, bad headache , fatigue , body ached etc
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia
Clinical narrative: Fever,  rapid heart beat,  dizzy, tired, bad headache , fatigue , body ached etc