chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Dry skin, Pruritus, Skin exfoliation
Clinical narrative: He experienced severe itchy, flaky, dry skin on both arms that started the day after receiving the immunizations and has persisted since.  He has applied moisturizers without much benefit.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Chromaturia, Endoscopy abnormal, Haematochezia, Malaise, Pain
Clinical narrative: Patient reported feeling body aches and pains starting 9/21/23 and started taking OTC Ibuprofen. He admitted taking medication on an empty stomach and in quantities more than recommended by manufacturer. He said that he continued feeling ill and took Ibuprofen until he went to the ER on 9/29/23. The physician onsite sent him home with the advice of stopping the Ibuprofen and switching to Tylenol. He returned to the ER on 10/3/23 with blood in his stool and dark urine. He was kept overnight in the hospital for observation and an endoscopy on 10/4/23, and was subsequently diagnosed with a bleeding ulcer. He was discharged on 10/5/23 with prescriptions for Sucralfate and Pantoprazole.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Ulcer haemorrhage
Clinical narrative: Patient reported feeling body aches and pains starting 9/21/23 and started taking OTC Ibuprofen. He admitted taking medication on an empty stomach and in quantities more than recommended by manufacturer. He said that he continued feeling ill and took Ibuprofen until he went to the ER on 9/29/23. The physician onsite sent him home with the advice of stopping the Ibuprofen and switching to Tylenol. He returned to the ER on 10/3/23 with blood in his stool and dark urine. He was kept overnight in the hospital for observation and an endoscopy on 10/4/23, and was subsequently diagnosed with a bleeding ulcer. He was discharged on 10/5/23 with prescriptions for Sucralfate and Pantoprazole.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Moderate aches, sore arm, moderate fatigue
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received AREXVY on the Left arm and Spikevax on the right arm on 9/29/23.  Patient reported  on 10/02/23 that the next day post vaccination, on 9/30/23 that her left arm (AREXVY ) had redness,  swelling and warmth. Patient returned to the pharmacy to fill an antibiotic on 10/02/23 and stated that her doctor diagnosed her with cellulitis.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: PAIN, LOWER BACK, BETWEEN THE SHOULDER BLADES, CANT MOVE ARM/SHOULDER
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Migraine, Muscle fatigue, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Whole body muscle aches, muscle fatigue, skin tingling, severe migraine,  fever (103°F)
Age: 71.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: redness, swelling, mild pain, itching, warmth
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain
Clinical narrative: Large, red, hot knot to right arm where injection was give. Knot appeared within 12 hours of administration. Pain with use of arm.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation, Chest X-ray abnormal, Chills, Condition aggravated, Confusional state
Clinical narrative: Unknown which RSV vaccine- it was not administered at our hospital1 Patient reports receiving flu and RSV vaccine the morning of 10/5 and that evening developed fever with chills. He later noticed diffuse rash on the left side of back with intense and took 2 doses of OTC Benadryl. Patient decided to visit the ER when symptoms failed to improve (see Item 19). He reports no similar complaints before, and this is his first RSV vaccine.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Lung opacity, Pruritus, Pyrexia, Rash, Tachycardia
Clinical narrative: Unknown which RSV vaccine- it was not administered at our hospital1 Patient reports receiving flu and RSV vaccine the morning of 10/5 and that evening developed fever with chills. He later noticed diffuse rash on the left side of back with intense and took 2 doses of OTC Benadryl. Patient decided to visit the ER when symptoms failed to improve (see Item 19). He reports no similar complaints before, and this is his first RSV vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Intermenstrual bleeding
Clinical narrative: Pfizer fall 2023 dose. I had the same intense reaction as previous with two days of joint pain, chills, mild headache. My one new concern was atypical menstrual spotting only 10 days after start of last period, on a typical 27 day cycle. age 43 with regular 26-28 day period cycle.   Manufacturer and pharmacist should warn women or research why this is happening.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Immunoglobulin therapy, Paraesthesia oral, Pharyngeal paraesthesia, Urticaria
Clinical narrative: Timeline: 9/26: Presented to ED w/ cat bite on her R elbow; received 7 day course of clindamycin and initiated rabies immunoglobulin (HRIG) and vaccine #1 (day 0); tetanus was UTD 9/29: Returned to ED for rabies vax #2 (day 3) 10/2: Completed clindamycin course 10/3: Returned to ED for rabies vax #3 (day 7) 10/5: Returned to ED w/ concern for possible allergic reaction - diffuse urticarial rash to face, neck, chest, arms, BLE; received IV diphenhydramine, solu-medrol 125mg, pepcid; discharged w/ diphenhydramine 25mg Q6H PRN and 5 day course of 20mg prednisone 10/7: Returned to ED w/ urticarial rash, as well as lip and throat tingling - treatment above   Received rabies vaccine PCEC formulation; due for 1 further booster on day 14 - 10/10.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial spasm, Gastrointestinal pain, Muscle tightness, Neck pain, Pyrexia
Clinical narrative: Development of tetanus after recieving covid 19 vaccine symptoms include jaw contraction stomach spasm fever severe neck pain, facial spasms
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tetanus
Clinical narrative: Development of tetanus after recieving covid 19 vaccine symptoms include jaw contraction stomach spasm fever severe neck pain, facial spasms
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: Development of tetanus after recieving covid 19 vaccine symptoms include jaw contraction stomach spasm fever severe neck pain, facial spasms
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Facial spasm, Hypertension, Neck pain
Clinical narrative: Development of tetanus after recieving covid 19 vaccine symptoms include jaw contraction stomach spasm fever severe neck pain, facial spasms
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tetanus, Trismus
Clinical narrative: Development of tetanus after recieving covid 19 vaccine symptoms include jaw contraction stomach spasm fever severe neck pain, facial spasms
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I am post-menopausal and have not had a period since June 2022 but I started having a light period about 45 hours after receiving the vaccine. This did happen with some of my earlier Pfizer covid vaccines but I was perimenopausal then.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: sudden heavy menstral period with extremally painful cramping.  Exactly 5 days post vaccine (this happens after each MRNA vaccine). Thought I was in menopause but guess not.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Limb discomfort, Pain, Photopsia
Clinical narrative: HER HAIR WAS FALLING OUT; SORENESS AND PAIN FROM THE VACCINE; HER CHEST WAS ALL RED LIKE SHE HAD A BAD RASH; HER SHOULDER WAS HURTING FOR TOO LONG; HER ARM WAS KILLING HER; VITREOUS FLOATERS; VITREOUS FLASHES; This spontaneous report received from a patient concerned a 4 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. Patient does not have a prior history of eye problems nor heart conditions. The patient experienced cold symptoms when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 31 years old. No concomitant medications were reported. On 2021, the patient experienced vitreous floaters, and vitreous flashes. On an unspecified date, the patient experienced her hair was falling out, soreness and pain from the vaccine, her chest was all red like she had a bad rash, her shoulder was hurting for too long, and her arm was killing her. Laboratory data (dates unspecified) included: COVID-19 virus test didn't have virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vitreous floaters, and vitreous flashes, and the outcome of her chest was all red like she had a bad rash, soreness and pain from the vaccine, her hair was falling out, her shoulder was hurting for too long and her arm was killing her was not reported. This report was non-serious. This report was associated with product quality complaint 90000299490.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Vitreous floaters
Clinical narrative: HER HAIR WAS FALLING OUT; SORENESS AND PAIN FROM THE VACCINE; HER CHEST WAS ALL RED LIKE SHE HAD A BAD RASH; HER SHOULDER WAS HURTING FOR TOO LONG; HER ARM WAS KILLING HER; VITREOUS FLOATERS; VITREOUS FLASHES; This spontaneous report received from a patient concerned a 4 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. Patient does not have a prior history of eye problems nor heart conditions. The patient experienced cold symptoms when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 31 years old. No concomitant medications were reported. On 2021, the patient experienced vitreous floaters, and vitreous flashes. On an unspecified date, the patient experienced her hair was falling out, soreness and pain from the vaccine, her chest was all red like she had a bad rash, her shoulder was hurting for too long, and her arm was killing her. Laboratory data (dates unspecified) included: COVID-19 virus test didn't have virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vitreous floaters, and vitreous flashes, and the outcome of her chest was all red like she had a bad rash, soreness and pain from the vaccine, her hair was falling out, her shoulder was hurting for too long and her arm was killing her was not reported. This report was non-serious. This report was associated with product quality complaint 90000299490.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 85.0
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: Reaction to previous exposure to any vaccine
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Feeling hot, Hypotension, Loss of consciousness, Pulse abnormal
Clinical narrative: Syncope.  7 min after flu and RSV shots became extremely warm.  Called out, fainted.  Out for 1 1/2 minutes.  Blood pressure plummeted. Pharmacy called EMS and I was taken to Emergency by ambulance.  Never fainted from getting shots before.  Get flu shots annually.  I believe RSV was the reason.  Had EKG at Emergency and all was fine.  Discharged with Syncope disgnosis.
Age: 77.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Blood pressure decreased, Electrocardiogram normal, Feeling hot, Syncope
Clinical narrative: Syncope.  7 min after flu and RSV shots became extremely warm.  Called out, fainted.  Out for 1 1/2 minutes.  Blood pressure plummeted. Pharmacy called EMS and I was taken to Emergency by ambulance.  Never fainted from getting shots before.  Get flu shots annually.  I believe RSV was the reason.  Had EKG at Emergency and all was fine.  Discharged with Syncope disgnosis.
Sex: M
Vaccine: RSV, RSV
Symptoms: Hypercoagulation, Inflammation, Ischaemic stroke, Lethargy, Middle cerebral artery stroke
Clinical narrative: Suffered large MCA Ischemic stroke; facial droop; Memory loss; very lethargic; Sharp pain in head; vertigo; This serious case was reported by a consumer and described the occurrence of ischemic stroke in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included atrial fibrillation, anemia, cholesterol and blood pressure. Concomitant products included flecainide, irbesartan, rosuvastatin, folic acid and cyanocobalamin (Vitamin B12).   On 06-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced ischemic stroke (Verbatim: Suffered large MCA Ischemic stroke) (serious criteria hospitalization and GSK medically significant), facial droop (Verbatim: facial droop) (serious criteria hospitalization and GSK medically significant), memory loss (Verbatim: Memory loss) (serious criteria hospitalization), lethargy (Verbatim: very lethargic) (serious criteria hospitalization), headache (Verbatim: Sharp pain in head) (serious criteria hospitalization) and vertigo (Verbatim: vertigo) (serious criteria hospitalization).  The outcome of the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo were not resolved.   It was unknown if the reporter considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.     It was unknown if the company considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.   Additional Information: GSK receipt date: 2-Oct-2023 The patient suffered large MCA Ischemic stroke, went emergency room and hospitalized trying to recover.  The patient's wife had typed all this information into the computer for him. The patient also had memory loss and facial droop and ever since vaccine, the patient had have felt very lethargic since vaccine administration.  Sharp pain in head top right and severe vertigo. She too has had serious adverse events from this vaccine.  The reporter consented to follow-up.
Sex: M
Vaccine: RSV, RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: Suffered large MCA Ischemic stroke; facial droop; Memory loss; very lethargic; Sharp pain in head; vertigo; This serious case was reported by a consumer and described the occurrence of ischemic stroke in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included atrial fibrillation, anemia, cholesterol and blood pressure. Concomitant products included flecainide, irbesartan, rosuvastatin, folic acid and cyanocobalamin (Vitamin B12).   On 06-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced ischemic stroke (Verbatim: Suffered large MCA Ischemic stroke) (serious criteria hospitalization and GSK medically significant), facial droop (Verbatim: facial droop) (serious criteria hospitalization and GSK medically significant), memory loss (Verbatim: Memory loss) (serious criteria hospitalization), lethargy (Verbatim: very lethargic) (serious criteria hospitalization), headache (Verbatim: Sharp pain in head) (serious criteria hospitalization) and vertigo (Verbatim: vertigo) (serious criteria hospitalization).  The outcome of the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo were not resolved.   It was unknown if the reporter considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.     It was unknown if the company considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.   Additional Information: GSK receipt date: 2-Oct-2023 The patient suffered large MCA Ischemic stroke, went emergency room and hospitalized trying to recover.  The patient's wife had typed all this information into the computer for him. The patient also had memory loss and facial droop and ever since vaccine, the patient had have felt very lethargic since vaccine administration.  Sharp pain in head top right and severe vertigo. She too has had serious adverse events from this vaccine.  The reporter consented to follow-up.
Sex: M
Vaccine: RSV, RSV
Symptoms: Amnesia, Facial paralysis, Headache, Ischaemic stroke, Lethargy
Clinical narrative: Suffered large MCA Ischemic stroke; facial droop; Memory loss; very lethargic; Sharp pain in head; vertigo; This serious case was reported by a consumer and described the occurrence of ischemic stroke in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included atrial fibrillation, anemia, cholesterol and blood pressure. Concomitant products included flecainide, irbesartan, rosuvastatin, folic acid and cyanocobalamin (Vitamin B12).   On 06-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced ischemic stroke (Verbatim: Suffered large MCA Ischemic stroke) (serious criteria hospitalization and GSK medically significant), facial droop (Verbatim: facial droop) (serious criteria hospitalization and GSK medically significant), memory loss (Verbatim: Memory loss) (serious criteria hospitalization), lethargy (Verbatim: very lethargic) (serious criteria hospitalization), headache (Verbatim: Sharp pain in head) (serious criteria hospitalization) and vertigo (Verbatim: vertigo) (serious criteria hospitalization).  The outcome of the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo were not resolved.   It was unknown if the reporter considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.     It was unknown if the company considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.   Additional Information: GSK receipt date: 2-Oct-2023 The patient suffered large MCA Ischemic stroke, went emergency room and hospitalized trying to recover.  The patient's wife had typed all this information into the computer for him. The patient also had memory loss and facial droop and ever since vaccine, the patient had have felt very lethargic since vaccine administration.  Sharp pain in head top right and severe vertigo. She too has had serious adverse events from this vaccine.  The reporter consented to follow-up.
Sex: M
Vaccine: RSV, RSV
Symptoms: Middle cerebral artery stroke, Vertigo
Clinical narrative: Suffered large MCA Ischemic stroke; facial droop; Memory loss; very lethargic; Sharp pain in head; vertigo; This serious case was reported by a consumer and described the occurrence of ischemic stroke in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included atrial fibrillation, anemia, cholesterol and blood pressure. Concomitant products included flecainide, irbesartan, rosuvastatin, folic acid and cyanocobalamin (Vitamin B12).   On 06-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced ischemic stroke (Verbatim: Suffered large MCA Ischemic stroke) (serious criteria hospitalization and GSK medically significant), facial droop (Verbatim: facial droop) (serious criteria hospitalization and GSK medically significant), memory loss (Verbatim: Memory loss) (serious criteria hospitalization), lethargy (Verbatim: very lethargic) (serious criteria hospitalization), headache (Verbatim: Sharp pain in head) (serious criteria hospitalization) and vertigo (Verbatim: vertigo) (serious criteria hospitalization).  The outcome of the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo were not resolved.   It was unknown if the reporter considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.     It was unknown if the company considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.   Additional Information: GSK receipt date: 2-Oct-2023 The patient suffered large MCA Ischemic stroke, went emergency room and hospitalized trying to recover.  The patient's wife had typed all this information into the computer for him. The patient also had memory loss and facial droop and ever since vaccine, the patient had have felt very lethargic since vaccine administration.  Sharp pain in head top right and severe vertigo. She too has had serious adverse events from this vaccine.  The reporter consented to follow-up.
Age: 67.0
Sex: M
Vaccine: UNK, COVID19-2
Symptoms: Blood glucose increased, Glycosylated haemoglobin normal, Therapy change
Clinical narrative: On 9/28/23 a day after the patient  had his covid shot (Comirnaty), he started experiencing tightening in chest, feel sluggish, no fever, blood sugar spiked up to 300 mg/dL.  Patient is checking his blood glucose using Dexcom and injecting 2 units of Novolin R depending on his BG reading.
Age: 67.0
Sex: M
Vaccine: UNK, COVID19-2
Symptoms: Blood glucose increased, Chest discomfort, Sluggishness
Clinical narrative: On 9/28/23 a day after the patient  had his covid shot (Comirnaty), he started experiencing tightening in chest, feel sluggish, no fever, blood sugar spiked up to 300 mg/dL.  Patient is checking his blood glucose using Dexcom and injecting 2 units of Novolin R depending on his BG reading.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoacusis, Musculoskeletal stiffness, Tinnitus
Clinical narrative: STIFF NECK ON LEFT SIDE AND RINGING IN EARS
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Tinnitus
Clinical narrative: STIFF NECK ON LEFT SIDE AND RINGING IN EARS
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Injection site pain; Neck muscle soreness; Shoulder soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain), muscle soreness (Verbatim: Neck muscle soreness) and shoulder soreness (Verbatim: Shoulder soreness).  The outcome of the injection site pain, muscle soreness and shoulder soreness were not reported.   It was unknown if the reporter considered the injection site pain, muscle soreness and shoulder soreness to be related to Arexvy.     It was unknown if the company considered the injection site pain, muscle soreness and shoulder soreness to be related to Arexvy.   Additional Information: GSK Receipt date: 28-SEP-2023 This case was reported by patient via interactive digital media. It was reported that patient experienced injection site pain, neck muscle soreness and shoulder soreness after receiving Arexvy vaccine. Follow up was not possible, as no contact details were available.
Sex: M
Vaccine: RSV
Symptoms: Erythema, Fatigue, Pain in extremity, Rash
Clinical narrative: rash on arm; arm tenderness; redness; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 22-SEP-2023, the patient received Arexvy (unknown arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced erythema (Verbatim: redness). On 23-SEP-2023, the patient experienced rash (Verbatim: rash on arm), pain in arm (Verbatim: arm tenderness) and fatigue (Verbatim: fatigue).  The outcome of the rash and pain in arm were unknown and the outcome of the fatigue was resolved (duration 1 day) and the outcome of the erythema was not reported.   It was unknown if the reporter considered the rash, pain in arm, fatigue and erythema to be related to Arexvy.     It was unknown if the company considered the rash, pain in arm, fatigue and erythema to be related to Arexvy.   Additional Information: GSK Receipt date: 28-SEP-2023 The reporter was a patient's wife. The reporter reported that patient received Arexvy and he experienced rash on arm, arm tenderness, and fatigue. Reporter reported that patient's fatigue lasted 1 day, the day after the vaccine. Reporter was unsure if redness resolved as patient could not roll up his sleeve that high at time of call. Reporter declined to provide any further details. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: 1st Moderna booster made her end up in the hospital; This spontaneous case was reported by a patient and describes the occurrence of HOSPITALISATION (1st Moderna booster made her end up in the hospital) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Seizures.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (1st Moderna booster made her end up in the hospital) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (1st Moderna booster made her end up in the hospital) outcome was unknown.            No concomitant medications were reported.  She mentioned that the first Moderna booster made her end up in the hospital; 2nd booster was advised by her doctor to prevent seizures; 3rd booster was successful.  Company Comment This spontaneous case concerns an elderly female patient with medical history of Seizures who experienced the seriousness criteria hospitalization unexpected event of hospitalization unknown days after SPIKEVAX NOS vaccine. She mentioned that the first Moderna booster made her end up in the hospital; 2nd booster was advised by her doctor to prevent seizures; 3rd booster was successful. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   No treatment medications were provided.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: administration of inadequate dose as they screwed on the needle tight but when they administered, a good amount squirted out the space where the needle was attached with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves 69 years old female patient who had administration of inadequate dose as they screwed on the needle tight but when they administered, a good amount squirted out the space where the needle was attached with no reported adverse event while receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Sep-2023, the patient received a total dose of suspect influenza quadrival A-B high dose HV vaccine (formulation, strength, dosage- not reported) (lot U8132DA, expiry date- 01-JUN-2024) via unknown route in unknown administration site for Immunization.  On 29-SEP-2023 the patient had administration of inadequate dose as they screwed on the needle tight but when they administered, a good amount squirted out the space where the needle was attached with no reported adverse event (incorrect dose administered) (latency- same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Pharmacist wants to know if there are any guidelines regarding revaccination FLUZONE HD QIV  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Injection site soreness, swelling, bruising of entire upper arm and rash. Never had  a reaction to any vaccine before.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure abnormal, Blood pressure increased, Body temperature increased, Fatigue
Clinical narrative: I received the updated Pfizer (comirnaty) mono booster 10/6/23 and had general malaise, moderate to severe body aches, elevated body temp and extreme tiredness. In addition I had severe soreness at the injection site. As the day went on, I had increasing blood pressure and heart rate, neither of which I have a problem with normally. (My metoprolol is prescribed off label for another reason, not hypertension and I have no cardiac issues). I always have a normal BP and by the time I was at my worst feeling I was stage 2 hypertensive at 134/83 with a general heart rate of around 80-85. Normal resting rate is around 60-65. I woke up feeling less sick today, 10/8 but throughout the day I have a large red bump, and moderate to severe itchiness at injection site. I also have lymph pain in my upper body on that side. I have had a couple abnormal BP readings today but not consistently and my heart rate has been largely normal but has also spiked a few times. I do still have joint pain today.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: I received the updated Pfizer (comirnaty) mono booster 10/6/23 and had general malaise, moderate to severe body aches, elevated body temp and extreme tiredness. In addition I had severe soreness at the injection site. As the day went on, I had increasing blood pressure and heart rate, neither of which I have a problem with normally. (My metoprolol is prescribed off label for another reason, not hypertension and I have no cardiac issues). I always have a normal BP and by the time I was at my worst feeling I was stage 2 hypertensive at 134/83 with a general heart rate of around 80-85. Normal resting rate is around 60-65. I woke up feeling less sick today, 10/8 but throughout the day I have a large red bump, and moderate to severe itchiness at injection site. I also have lymph pain in my upper body on that side. I have had a couple abnormal BP readings today but not consistently and my heart rate has been largely normal but has also spiked a few times. I do still have joint pain today.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymph node pain, Malaise, Pain
Clinical narrative: I received the updated Pfizer (comirnaty) mono booster 10/6/23 and had general malaise, moderate to severe body aches, elevated body temp and extreme tiredness. In addition I had severe soreness at the injection site. As the day went on, I had increasing blood pressure and heart rate, neither of which I have a problem with normally. (My metoprolol is prescribed off label for another reason, not hypertension and I have no cardiac issues). I always have a normal BP and by the time I was at my worst feeling I was stage 2 hypertensive at 134/83 with a general heart rate of around 80-85. Normal resting rate is around 60-65. I woke up feeling less sick today, 10/8 but throughout the day I have a large red bump, and moderate to severe itchiness at injection site. I also have lymph pain in my upper body on that side. I have had a couple abnormal BP readings today but not consistently and my heart rate has been largely normal but has also spiked a few times. I do still have joint pain today.
Age: 71.0
Sex: M
Vaccine: FLUA4, PNC20
Symptoms: Dyspnoea, Pharyngeal swelling, Pyrexia, Tremor, Vomiting
Clinical narrative: Fever 102.4, Vomiting, Swollen Throat, Hard time breathing, Violent Shaking
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash morbilliform
Clinical narrative: morbilliform rash  over arms and torso to buttocks
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL vaccine was administered with no reported adverse event; Initial information was received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient to whom an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) and rotavirus vaccine LIVE ORAL 1V (Rotarix) for Prophylactic vaccination.  On 28-Sep-2023, the patient received a 0.5 ml, once (dose 2) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ682AA, expiry date: 16-Sep-2023, strength: standard) via intramuscular route in Right thigh for Immunization and administered an expired vaccine with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Tetanus, Vaccination failure
Clinical narrative: Tetanus vaccine did not work as previously diagnosed and reporting symptoms of tetanus and failure to treat with Valium and flagyl
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea, Fatigue, Pain
Clinical narrative: Tired Aches Diarrhea
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain (8-10 on pain scale) that lasted 3 days following the injection before reducing to a 5-6 on the pain scale, and immobility of the left arm. Arm pain lessened, but pain persists in what feels like my joint on the left arm where shot was administered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe nausea, headache, extreme fatigue, body aches
Age: 66.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives, rash, itching
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received 18+ vaccine product at age 17
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Bursitis
Clinical narrative: Olecranon Bursitis (left)-given Voltaren Gel to use 3 times a day, pending outcome
Age: 88.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Death
Clinical narrative: Resident passed away on 10/8/23 at facility. Resident transfer on 10/3/23 to facility for LTC.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Cough, Vomiting
Clinical narrative: Hospitalized for cough , weakness, vomiting
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Duodenal ulcer
Clinical narrative: Duodenal ulcer, asymptomatic for COVID infection
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Oropharyngeal pain, Productive cough
Clinical narrative: weakness, productive cough, sore throat, shortness of breath, fatigue.
Age: 78.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Brain fog, Dizziness, Fall, Musculoskeletal disorder
Clinical narrative: I don't remember how, or what time it was nor how I got to the floor, but I never experienced fainting, but I felt faint. I was very foggy, almost like unaware of me being on the floor. I am not sure if I fell or was trying to get into my recliner and landed on the floor. I landed on the floor first. I had absolutely no muscle control in my legs and barely in my arms to prop myself up to get into that recliner. As I was on the floor trying to get up, it was almost like I was paralyzed, then after a few mins I was finally able to get into the chair.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Pneumonia bacterial
Clinical narrative: COVID PNA + bacterial pna
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Malaise, Pallor, Sensory disturbance, Syncope
Clinical narrative: Patient received 3 IM injections during routine immunization visit, and shortly after 3rd injection had approx 10 second unresponsive "fainting spell", came to, but continued to feel unwell, was pale and sweaty, and complained of legs feeling "weird" and shaky.  Had patient lay on floor and EMS was called to assess patient.  After patient condition improved after approx 10 minutes, patient was cleared to leave clinic with mother.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Patient received 3 IM injections during routine immunization visit, and shortly after 3rd injection had approx 10 second unresponsive "fainting spell", came to, but continued to feel unwell, was pale and sweaty, and complained of legs feeling "weird" and shaky.  Had patient lay on floor and EMS was called to assess patient.  After patient condition improved after approx 10 minutes, patient was cleared to leave clinic with mother.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: FLU vaccine administered R  arm swelling at the injection site
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray, Dyspnoea, Fatigue, Oropharyngeal pain
Clinical narrative: Patient presented with fatigue, SOB to ER on 10/7/23. Sore throat and other symptoms started 8-9 days prior to admission. Provider consulted on 10/9/23 and stated patient was improved and hopeful for discharge on 10/9/23.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient presented with fatigue, SOB to ER on 10/7/23. Sore throat and other symptoms started 8-9 days prior to admission. Provider consulted on 10/9/23 and stated patient was improved and hopeful for discharge on 10/9/23.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Hypotension, Swelling face, Urticaria
Clinical narrative: Staff at hospital reported to pharmacy that patient was admitted with swelling in the face, hives and severe hypotension on 10/7/23 @ 5:45pm at the ER.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RED RASH ON ARM ABOUT 5 INCHES IN LENGTH. STARTED ON 10/6 AND STILL PRESENT ON 10/9.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Employee was able to schedule COVID vaccine although Employee Health was not going to start administering until 10/9/23.  Was screening with flu questionnaire and read flu VIS, but thought he was getting COVID.  Was administered flu, also had gotten flu vaccine 9/26/23.  Was notified by staff when staff attempted to cancel appointment as COVID vaccine not yet available.    Reports no adverse side effects at this time.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Headache, Pallor, Tinnitus
Clinical narrative: Symtpoms: dizzy, clammy, vomit, pale, ringing in ears, headache after symptoms got better Patient was given water, juice, and assisted to laying down. patient reported feeling better after but with a headache.  This happened within 20-25 minutes after vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Symtpoms: dizzy, clammy, vomit, pale, ringing in ears, headache after symptoms got better Patient was given water, juice, and assisted to laying down. patient reported feeling better after but with a headache.  This happened within 20-25 minutes after vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Two days after getting vaccine I began having diarhea and it lasted for almost a week.  I am sure it was the vaccine because  did not eat or drink anything unusual or that would cause loose stools.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old patient came in to the HU on 10/3/23 for flu vaccination. Flu vaccine was pulled from Accutemp cooler and given to 17-year-old female in left deltoid per request. When documenting vaccine information on consent form after vaccine was administered, RN realized the vaccine was the Fluzone 65+ influenza vaccine. The RN called CDNS immediately after realization. Employee reported to PCM and Immunization Program Nurse. Dr was notified by IP Nurse and no orders/recommendations were received. The parent was notified of increased risk of side effects due to higher dose of vaccine administered. VAERs completed. RN
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient received shot Friday afternoon and called Monday morning stating she has a rash about 2.5" by 6" long going down her arm starting at the injection site. She said it doesn't itch or burn or hurt upon moving, but it does hurt if she touches it.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Vaccine not diluted
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Vaccine not diluted
Age: 69.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Cardiac arrest, Death, Electrocardiogram abnormal, Malaise, Pain in extremity
Clinical narrative: Manufacturer of COVID booster and RSV vaccines administered on 9/28/2023 are UNKNOWN at this time. Patient had his seasonal influenza vaccination "3 to 4 weeks" prior to receiving a COVID booster and RSV vaccine.  He was in his usual state of health on 9/28/2023 when the COVID booster and RSV vaccines were administered in his deltoids.  According to his wife (who is my sister) his arms were sore afterward, then 24 to 48 hours later on Saturday, 9/30/2023, he "didn't feel well" and felt worse as the evening progressed, so she took him to their local hospital ED for evaluation.  On arrival, he was triaged immediately and his vital signs were checked and an EKG was done which was grossly "abnormal".  As they rushed him back to an ED treatment room, he slumped in his wheelchair and he was transferred to a stretcher in cardiac arrest.  ACLS was initiated and he was unable to be resuscitated, and he was pronounced in the ED.  To my knowledge, he has no cardiac history and he had a "routine" cardiac work up "a couple of months ago" which was unremarkable.  He had routine follow up scheduled in the coming months.  I will attempt to obtain further details at his funeral on this Friday, October 13 including the name of his PCP and the hospital where he was taken.