chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MEN
Symptoms: Loss of consciousness, Seizure
Clinical narrative: three seizures; passed out three times; Initial information was received on 27-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case involves an adolescent male patient who experienced three seizures and passed out three times after receiving meningococcal vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect meningococcal vaccine, booster dose, produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient developed three seizures (seizure) and passed out three times (loss of consciousness) (same day latency) following the administration of meningococcal vaccine.  Action taken with meningococcal vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (three seizures, passed out three times).  At time of reporting, the outcome was Unknown for the events three seizures and passed out three times.  Seriousness criteria : Medically significant for both the events.; Sender's Comments: Sanofi Company Comment dated 03-Oct-2023 : This case involves an unknown age adolescent male patient who experienced three seizures and passed out three times after receiving meningococcal vaccine. Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: they have reconstituted acthib with a sterile diluent that comes with the live vaccines, and administered it to a patient with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient and the reporter stated they have reconstituted HIB (PRP/T) vaccine [ACT-HIB] with a sterile diluent that comes with the live vaccines, and administered it to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown (total) dose of suspect HIB (PRP/T) vaccine,  Powder and solvent for solution for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for immunization and they have reconstituted acthib with a sterile diluent that comes with the live vaccines, and administered it to a patient with no reported adverse event (product preparation error) (unknown latency).  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  Outcome: Unknown.    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 and Regulatory Authority 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.
Sex: F
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: had a seizure; This spontaneous report was received from a consumer (the patient's mother) referring to a female patient of unknown age. The patient's medical history and concomitant therapies were not reported. The patient was very sensitive and had a lot of food allergies.   On an unknown date in November 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (dose, strength, lot #, expiration date and route of administration were not provided).  On an unknown date in November 2019 (reported as when she got measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)), the patient had a seizure. The patient went to the emergency room and sought medical attention but it was unknown whether treatment was provided or lab diagnostics/ studies were performed. At the time of reporting, the outcome of the event seizure was unknown.   The causal relationship between seizure and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.   Upon internal review, the event seizure was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; ROTATEQ  was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-SEP-2023, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis after temperature excursion (lot# 1968393, expiration date: 24-MAY-2024; strength was not provided). The vaccine was improper stored at 8.9 degree Celsius for 12 hours 20 mins on 14-AUG-2023 and at 9.4 degree Celsius for 8 hours 20 mins on 28-AUG-2023 (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site erythema
Clinical narrative: She mentioned she had minor side effects with the past Moderna vaccines; She usually gets a red arm that stays red for a long time, even with the flu shot; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She mentioned she had minor side effects with the past Moderna vaccines) and VACCINATION SITE ERYTHEMA (She usually gets a red arm that stays red for a long time, even with the flu shot) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: RSV  (RSV vaccine 2 weeks ago) and Flu Shot. Past adverse reactions to the above products included Injection site redness with Flu Shot; and No adverse effect with RSV . Concurrent medical conditions included Penicillin allergy.    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 IMMUNISATION REACTION (She mentioned she had minor side effects with the past Moderna vaccines) and VACCINATION SITE ERYTHEMA (She usually gets a red arm that stays red for a long time, even with the flu shot). At the time of the report, IMMUNISATION REACTION (She mentioned she had minor side effects with the past Moderna vaccines) and VACCINATION SITE ERYTHEMA (She usually gets a red arm that stays red for a long time, even with the flu shot) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had minor side effects with the past Moderna vaccines. She usually gets a red arm that stays red for a long time. She doesn't have her vaccination card with her.  Patient received the latest Moderna vaccine this past Sunday 01Oct2023.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743516:Same patient, SPIKEVAX 2023-2024 Vaccine
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Chills, fever,  body aches, fatigue, headaches, nausea
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever,  body aches, fatigue, headaches, nausea
Age: 79.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site vesicles
Clinical narrative: LEFT ARM DEVELOPED CLEAR FLUID FILLED BLISTERS  4 INCHES BY 6 INCHES AREA SIZE MEDIAL AND DISTAL TO IM INJECTION SITE
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Cough, Fatigue, Influenza virus test negative, Myalgia
Clinical narrative: Congested, sore throat, painful chest cough, rattled breathing, achy muscles, extremely tired and weak
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Oropharyngeal pain, Respiration abnormal, Respiratory tract congestion, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Congested, sore throat, painful chest cough, rattled breathing, achy muscles, extremely tired and weak
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, Rash, Rash erythematous
Clinical narrative: I received a spikevax injection ( moderna ) on 10/3/2023 at 1330 hours I became tired, dizzy and achey and also developed a red rash on my abdomen and trunk this morning I saw the dermatologist to confirm it was not shingles. ( the rash is on both sides of midline so unlikely ) The rash has receded without treatment this evening.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Dermatitis bullous, Eye pain, Eye swelling, Headache
Clinical narrative: Patient received Shingrix vaccine on 9/12/23 approximately 3:30 pm. She reports went home and noticed some left facial swelling. Her son thought it may have been due to her concurrent toothache (broken tooth), which she had a dental appointment for the next day. During her dental appointment on 9/13/23, the dentist confirmed via x-ray that the facial swelling was not caused by her broken tooth. Patient went home on antibiotics: cleocin 300 mg, and meloxicam 7.5 mg post tooth extraction. On 9/18/23, the patient's son contacted the clinic and informed triaged nurse that patient has left painful facial rash, swollen tongue and nose, and headache. Rash reaches left side of nose, including nostril and up to the left eye with conjunctivitis. It was reported swelling began on 9/15/23 an worsening. Patient confirmed no difficulty in breathing or swallowing. Patient was seen in the clinic or concerns for reactivation of shingles possibly with secondary skin infection and involvement of left eye. Patient was given acetaminophen 650 mg x 1 dose for headache and was sent to ER. Upon presentation in the ER, patient reported left eye swelling, pain. and blurry vision x 3 days. On physical exam, patient was positive for erythematous rash to the left cheek that extends from the bottom of her face up to the eye. There was overlying bulla/papules in various stages of healing and was very tender to the touch. Her (L) eye has conjunctival erythema, hutchinson sign positive, and V2 distribution of zoster. ER provider documents vesicles and distribution are consistent with herpes zoster. Patient was diagnosed with herpes zoster of the face (trigeminal nerve) and started on anti-viral therapy: valacyclovir 500 mg tabs: take 2 tablets three times a day for seven days. Patient was also prescribed a Medrol Dosepak.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Papule, Rash, Rash erythematous
Clinical narrative: Patient received Shingrix vaccine on 9/12/23 approximately 3:30 pm. She reports went home and noticed some left facial swelling. Her son thought it may have been due to her concurrent toothache (broken tooth), which she had a dental appointment for the next day. During her dental appointment on 9/13/23, the dentist confirmed via x-ray that the facial swelling was not caused by her broken tooth. Patient went home on antibiotics: cleocin 300 mg, and meloxicam 7.5 mg post tooth extraction. On 9/18/23, the patient's son contacted the clinic and informed triaged nurse that patient has left painful facial rash, swollen tongue and nose, and headache. Rash reaches left side of nose, including nostril and up to the left eye with conjunctivitis. It was reported swelling began on 9/15/23 an worsening. Patient confirmed no difficulty in breathing or swallowing. Patient was seen in the clinic or concerns for reactivation of shingles possibly with secondary skin infection and involvement of left eye. Patient was given acetaminophen 650 mg x 1 dose for headache and was sent to ER. Upon presentation in the ER, patient reported left eye swelling, pain. and blurry vision x 3 days. On physical exam, patient was positive for erythematous rash to the left cheek that extends from the bottom of her face up to the eye. There was overlying bulla/papules in various stages of healing and was very tender to the touch. Her (L) eye has conjunctival erythema, hutchinson sign positive, and V2 distribution of zoster. ER provider documents vesicles and distribution are consistent with herpes zoster. Patient was diagnosed with herpes zoster of the face (trigeminal nerve) and started on anti-viral therapy: valacyclovir 500 mg tabs: take 2 tablets three times a day for seven days. Patient was also prescribed a Medrol Dosepak.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swollen tongue, Tenderness, Tooth extraction, Vision blurred
Clinical narrative: Patient received Shingrix vaccine on 9/12/23 approximately 3:30 pm. She reports went home and noticed some left facial swelling. Her son thought it may have been due to her concurrent toothache (broken tooth), which she had a dental appointment for the next day. During her dental appointment on 9/13/23, the dentist confirmed via x-ray that the facial swelling was not caused by her broken tooth. Patient went home on antibiotics: cleocin 300 mg, and meloxicam 7.5 mg post tooth extraction. On 9/18/23, the patient's son contacted the clinic and informed triaged nurse that patient has left painful facial rash, swollen tongue and nose, and headache. Rash reaches left side of nose, including nostril and up to the left eye with conjunctivitis. It was reported swelling began on 9/15/23 an worsening. Patient confirmed no difficulty in breathing or swallowing. Patient was seen in the clinic or concerns for reactivation of shingles possibly with secondary skin infection and involvement of left eye. Patient was given acetaminophen 650 mg x 1 dose for headache and was sent to ER. Upon presentation in the ER, patient reported left eye swelling, pain. and blurry vision x 3 days. On physical exam, patient was positive for erythematous rash to the left cheek that extends from the bottom of her face up to the eye. There was overlying bulla/papules in various stages of healing and was very tender to the touch. Her (L) eye has conjunctival erythema, hutchinson sign positive, and V2 distribution of zoster. ER provider documents vesicles and distribution are consistent with herpes zoster. Patient was diagnosed with herpes zoster of the face (trigeminal nerve) and started on anti-viral therapy: valacyclovir 500 mg tabs: take 2 tablets three times a day for seven days. Patient was also prescribed a Medrol Dosepak.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray dental
Clinical narrative: Patient received Shingrix vaccine on 9/12/23 approximately 3:30 pm. She reports went home and noticed some left facial swelling. Her son thought it may have been due to her concurrent toothache (broken tooth), which she had a dental appointment for the next day. During her dental appointment on 9/13/23, the dentist confirmed via x-ray that the facial swelling was not caused by her broken tooth. Patient went home on antibiotics: cleocin 300 mg, and meloxicam 7.5 mg post tooth extraction. On 9/18/23, the patient's son contacted the clinic and informed triaged nurse that patient has left painful facial rash, swollen tongue and nose, and headache. Rash reaches left side of nose, including nostril and up to the left eye with conjunctivitis. It was reported swelling began on 9/15/23 an worsening. Patient confirmed no difficulty in breathing or swallowing. Patient was seen in the clinic or concerns for reactivation of shingles possibly with secondary skin infection and involvement of left eye. Patient was given acetaminophen 650 mg x 1 dose for headache and was sent to ER. Upon presentation in the ER, patient reported left eye swelling, pain. and blurry vision x 3 days. On physical exam, patient was positive for erythematous rash to the left cheek that extends from the bottom of her face up to the eye. There was overlying bulla/papules in various stages of healing and was very tender to the touch. Her (L) eye has conjunctival erythema, hutchinson sign positive, and V2 distribution of zoster. ER provider documents vesicles and distribution are consistent with herpes zoster. Patient was diagnosed with herpes zoster of the face (trigeminal nerve) and started on anti-viral therapy: valacyclovir 500 mg tabs: take 2 tablets three times a day for seven days. Patient was also prescribed a Medrol Dosepak.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: My heart hurt. At first I thought it was my breast so I went to MD and had a thorough exam of my left breast...nothing was found. Upon reading about COVID vaccines causing heart inflammation, I figured that's what the pain was
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Aspiration pleural cavity, Atelectasis, Chest X-ray, Computerised tomogram thorax abnormal
Clinical narrative: Dyspnea Onset date: 9/27/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) 0n 10/17/2022 HOSPITAL COURSE: 9/27/2023-9/28/2023 study patient went to the hospital instead of his dialysis appointment due to shortness of breath at rest on 9/27/2023. In the ED, he had elevated, but flat troponins (141, 134, 127). CT scan showed loculated pleural effusion in the left long, worse than previous in June( has ongoing AE of Plural. Nephrology was consulted, and dialysis was performed on 9/27/23. He was given twice his normal dose of Lasix and thoracentesis was performed on 9/28/2023. He was discharged on 9/28/2023 with improvement of symptoms. Study Principal Investigator has assessed the causality as not study related.
Sex: F
Vaccine: COVID19
Symptoms: Dialysis, Dyspnoea at rest, Pleural effusion, Scan with contrast abnormal, Therapy change
Clinical narrative: Dyspnea Onset date: 9/27/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) 0n 10/17/2022 HOSPITAL COURSE: 9/27/2023-9/28/2023 study patient went to the hospital instead of his dialysis appointment due to shortness of breath at rest on 9/27/2023. In the ED, he had elevated, but flat troponins (141, 134, 127). CT scan showed loculated pleural effusion in the left long, worse than previous in June( has ongoing AE of Plural. Nephrology was consulted, and dialysis was performed on 9/27/23. He was given twice his normal dose of Lasix and thoracentesis was performed on 9/28/2023. He was discharged on 9/28/2023 with improvement of symptoms. Study Principal Investigator has assessed the causality as not study related.
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Dyspnea Onset date: 9/27/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) 0n 10/17/2022 HOSPITAL COURSE: 9/27/2023-9/28/2023 study patient went to the hospital instead of his dialysis appointment due to shortness of breath at rest on 9/27/2023. In the ED, he had elevated, but flat troponins (141, 134, 127). CT scan showed loculated pleural effusion in the left long, worse than previous in June( has ongoing AE of Plural. Nephrology was consulted, and dialysis was performed on 9/27/23. He was given twice his normal dose of Lasix and thoracentesis was performed on 9/28/2023. He was discharged on 9/28/2023 with improvement of symptoms. Study Principal Investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Lumbar puncture, Magnetic resonance imaging, Paraesthesia, Polyneuropathy
Clinical narrative: On 9/27/23 he received a Pfizer COVID vaccine. On 10/3/23 he presented to the hospital with paresthesia and progressive polyneuropathy. Imaging MRI, CT scan, LP completed during hospitalization. Current concern or GBS.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Pt reported a knot, redness and swelling that decreased over time
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: Patient got Abrysvo on 9/19/2023 five days later reported labored and difficulty breathing lasting or about 4 days.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: no
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Diarrhoea, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fatigue, diarrhea first day.  Low-grade fever and injection sites soreness (both arms) the second day.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Dizziness, Headache, Laryngitis, Oropharyngeal pain
Clinical narrative: Starting in the evening of 9/26/23 all over body aches, worsening headache; 9/27/23 Slight sore throat and sinus congestion; 9/28/23 laryngitis.  Patient also listed more symptoms:  cough, swelling of lower legs and feet, lightheadedness and also a rash on the front of both thighs.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Peripheral swelling, Rash, Sinus congestion
Clinical narrative: Starting in the evening of 9/26/23 all over body aches, worsening headache; 9/27/23 Slight sore throat and sinus congestion; 9/28/23 laryngitis.  Patient also listed more symptoms:  cough, swelling of lower legs and feet, lightheadedness and also a rash on the front of both thighs.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Disability, Gout, Mesenteric artery stent insertion, Norovirus infection
Clinical narrative: Debilitating pain in abdomen.  Blood clot occluding intestine and kidney. ROMS performed with stent placed in artery and half of small intestine removed because it was dead.  3 more procedures were required within 6 days. During surgery found blood clot in kidney and later found blood clot in lung. While in hospital for 5 weeks had gout, respiratory failure and contracted Norovirus.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Renal artery thrombosis, Respiratory failure, Small intestinal resection, Thrombosis
Clinical narrative: Debilitating pain in abdomen.  Blood clot occluding intestine and kidney. ROMS performed with stent placed in artery and half of small intestine removed because it was dead.  3 more procedures were required within 6 days. During surgery found blood clot in kidney and later found blood clot in lung. While in hospital for 5 weeks had gout, respiratory failure and contracted Norovirus.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Depressed level of consciousness, Fatigue, Headache, Malaise
Clinical narrative: Sudden onset of prostration lasting 48 hours followed by severe fatigue.  Needed to stay in bed for 48 hours. Headache during first 48 hours.  Intermittent burning nerve pains in hands and feet started after 48 hours.  Marked fatigue persists with cloudy sensorium. Today, 96 hours post vaccination there is a  sense of general malaise and brain fog.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain
Clinical narrative: Sudden onset of prostration lasting 48 hours followed by severe fatigue.  Needed to stay in bed for 48 hours. Headache during first 48 hours.  Intermittent burning nerve pains in hands and feet started after 48 hours.  Marked fatigue persists with cloudy sensorium. Today, 96 hours post vaccination there is a  sense of general malaise and brain fog.
Age: 32.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Bell's palsy, Chills, Dyspnoea, Electroencephalogram normal, Exposure during pregnancy
Clinical narrative: I received the flu shot and Covid booster at 38 weeks pregnant. Within 5 hours of the vaccines, I had a fever, chills and body aches. Those went away about 24 hours after (and are the same side effects I have had every time). Sunday morning so 36 hours later approximately, I had complete and total facial paralysis on one side, shortness of breath, shaking, headache. Went to emergency room and was diagnosed with Bell?s Palsy. Because I was having the weird sense of taste symptom the day before the vaccine, I have no idea if the vaccine played a roll. It?s possible it did not. Or maybe I was sick with something and the vaccine put my body in overdrive.
Age: 32.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Facial paralysis, Headache, Magnetic resonance imaging normal, Pain, Pyrexia
Clinical narrative: I received the flu shot and Covid booster at 38 weeks pregnant. Within 5 hours of the vaccines, I had a fever, chills and body aches. Those went away about 24 hours after (and are the same side effects I have had every time). Sunday morning so 36 hours later approximately, I had complete and total facial paralysis on one side, shortness of breath, shaking, headache. Went to emergency room and was diagnosed with Bell?s Palsy. Because I was having the weird sense of taste symptom the day before the vaccine, I have no idea if the vaccine played a roll. It?s possible it did not. Or maybe I was sick with something and the vaccine put my body in overdrive.
Age: 32.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Tremor
Clinical narrative: I received the flu shot and Covid booster at 38 weeks pregnant. Within 5 hours of the vaccines, I had a fever, chills and body aches. Those went away about 24 hours after (and are the same side effects I have had every time). Sunday morning so 36 hours later approximately, I had complete and total facial paralysis on one side, shortness of breath, shaking, headache. Went to emergency room and was diagnosed with Bell?s Palsy. Because I was having the weird sense of taste symptom the day before the vaccine, I have no idea if the vaccine played a roll. It?s possible it did not. Or maybe I was sick with something and the vaccine put my body in overdrive.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: PATIENT WAS MONITORED FOR 30 MINUTES AND THERE ARE NO ADVERSE EVENTS TO REPORT.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Right hand 4th and 5th digit numb after Spikevax
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Antimicrobial susceptibility test sensitive, Injection site abscess, Injection site erythema, Injection site mass
Clinical narrative: Patient received above vaccination at routine wellness exam on 9/14/2023. Around 8 days later he started with some redness and a lump neat the site of the vaccination. He was seen in the office on 9/29/2023 for this issue. It was determined at that time that he did have an abscess. He was started on Keflex (250mg/5ml taking 10ml twice daily for 20 days) at this visit. There was a culture done of the area at the visit as well that was sent to the lab. The culture came back sensitive to Oxacillin. Per Dr., he should continue the Keflex and the abscess should be resolving. She did follow up with patient on 10/02/23 and was unable to reach them.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Urticaria
Clinical narrative: Full body hives and severe headache- no breathing issues-pt took Benadryl and slept all night-woke up this AM and no hives were present. Minimal headache.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: Redness with some pain. Redness started small Tuesday morning and increased in size by Tuesday afternoon. Warm to the touch, some soreness and itchiness
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Calcinosis, Gait inability, Groin pain, Hypoaesthesia, Impaired work ability
Clinical narrative: Flu vaccine on 9/28/2023 felt fine just painful injection and arm sore, by Sat 9/30/23 my right leg felt slight pain in my thigh to my groin area, by 10/3/2023 evening time I could not walk and put pressure on my right leg, a knot appeared in upper thigh, by Wed 10/4/2023 I could not bare the pain any longer and went to the Emergency Room, ULTRASOUND AND xRAY COMPLETED WITH LAB WORK. I was told nodule calcification soft tissue posterior I could not walk at all, and the pain was unbearable with pelvic pain, leg pain, from thigh to foot, numbness, with sharp pain with any movement or pressure applied,  I was out of work 2 days with this condition that I have never encountered.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Laboratory test, Nodule, Pain, Pain in extremity
Clinical narrative: Flu vaccine on 9/28/2023 felt fine just painful injection and arm sore, by Sat 9/30/23 my right leg felt slight pain in my thigh to my groin area, by 10/3/2023 evening time I could not walk and put pressure on my right leg, a knot appeared in upper thigh, by Wed 10/4/2023 I could not bare the pain any longer and went to the Emergency Room, ULTRASOUND AND xRAY COMPLETED WITH LAB WORK. I was told nodule calcification soft tissue posterior I could not walk at all, and the pain was unbearable with pelvic pain, leg pain, from thigh to foot, numbness, with sharp pain with any movement or pressure applied,  I was out of work 2 days with this condition that I have never encountered.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pelvic pain, Ultrasound scan, Weight bearing difficulty, X-ray
Clinical narrative: Flu vaccine on 9/28/2023 felt fine just painful injection and arm sore, by Sat 9/30/23 my right leg felt slight pain in my thigh to my groin area, by 10/3/2023 evening time I could not walk and put pressure on my right leg, a knot appeared in upper thigh, by Wed 10/4/2023 I could not bare the pain any longer and went to the Emergency Room, ULTRASOUND AND xRAY COMPLETED WITH LAB WORK. I was told nodule calcification soft tissue posterior I could not walk at all, and the pain was unbearable with pelvic pain, leg pain, from thigh to foot, numbness, with sharp pain with any movement or pressure applied,  I was out of work 2 days with this condition that I have never encountered.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Chills, Decreased appetite, Diarrhoea, Discomfort, Extremity contracture
Clinical narrative: She got her vaccines, had no initial reaction, was fine, went home and went about her business.  Then on 10/1/23 she went to get up and coul dnot walk.  Every muscle were so painful, felt like somebody beat her up.  Her legs, back of her legs, her arms and she could not even touch her body the pain was so bad.  She went to go to the bathroom and itr was painful as it hurt to sit on the toilet due to the pain in the bakc of her legs.  She could not stretch her arms or anything.  She went to bed as she had chills.  She tried to get up and just satyed in bed.  Monday the same thing, she started moving her legs, moving her arms, stretching.  Wednesday she was better, yesterday she was better, and today she is better.  She took Naproxen this morning to help with the discomfort, and hopes that this helps.  She is out and driving but was afraid that her legs were going to to out.  Her legs were contracting, and the pain was severe.  She took some Tramadol on Tuesday and had to do something as she could not stay like that.  She did call her doctor and they could not see her until 11/7/23.  She did not want to go to the hospital.  She had no appetite for 3 days whatsoever.  The 3rd day she ate some bread, she had breakfast and dinner yesterday and now is feeling better.  She did have a slight headache, but that has gone, and she did have some diarrhea that lasted for the 3 days as well, that has improved now as well.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Gait inability, Headache, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: She got her vaccines, had no initial reaction, was fine, went home and went about her business.  Then on 10/1/23 she went to get up and coul dnot walk.  Every muscle were so painful, felt like somebody beat her up.  Her legs, back of her legs, her arms and she could not even touch her body the pain was so bad.  She went to go to the bathroom and itr was painful as it hurt to sit on the toilet due to the pain in the bakc of her legs.  She could not stretch her arms or anything.  She went to bed as she had chills.  She tried to get up and just satyed in bed.  Monday the same thing, she started moving her legs, moving her arms, stretching.  Wednesday she was better, yesterday she was better, and today she is better.  She took Naproxen this morning to help with the discomfort, and hopes that this helps.  She is out and driving but was afraid that her legs were going to to out.  Her legs were contracting, and the pain was severe.  She took some Tramadol on Tuesday and had to do something as she could not stay like that.  She did call her doctor and they could not see her until 11/7/23.  She did not want to go to the hospital.  She had no appetite for 3 days whatsoever.  The 3rd day she ate some bread, she had breakfast and dinner yesterday and now is feeling better.  She did have a slight headache, but that has gone, and she did have some diarrhea that lasted for the 3 days as well, that has improved now as well.
Age: 81.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Feeling cold, Headache, Musculoskeletal stiffness, Tremor
Clinical narrative: My wife and I received the RSV and the Covid shot, on Wednesday 9/27/23, we were good all day until we went to bed at 12:30. It started as soon as we got into bed. We started feeling cold, we started to shake most of the night, we had to put on 3 layers of blankets, that's how cold we were. The other symptoms which were on me only, were a very stiffness in my neck, plus a headache. My wife also had a very bad headache and shivering. The next day, we still had headaches. The food was not tasting right and my wife woke up with diarrhea that morning. We have never had such adverse effect from any shots. I am 81 and my wife is 72. We are now just starting to get a little bit better. I am still getting headaches, and so is my wife. And myself, I now have a sore throat, I think is from the adverse effects I am getting. I do not wish this on anyone.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Ascending flaccid paralysis, Gastrostomy, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Muscular weakness, Pain in extremity, Tracheostomy
Clinical narrative: Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Dizziness, Guillain-Barre syndrome, Influenza like illness, Injection site pain, Lumbar puncture
Clinical narrative: Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia
Clinical narrative: Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Ascending flaccid paralysis, Back pain, CSF protein increased, CSF white blood cell count negative, Gait inability
Clinical narrative: Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Ascending flaccid paralysis, Gastrostomy, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Flu-like symptoms for several days starting several hours after the vaccination; also soreness at injection site.  Subsequent sudden onset of tingling and weakness in lower extremities as well as light headed was beginning Sept 26, 2023 and progressing rapidly to near paralysis. Diagnosed with Guillaume-Barre Syndrome  October 2, 2023.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Muscular weakness, Pain in extremity, Tracheostomy
Clinical narrative: Flu-like symptoms for several days starting several hours after the vaccination; also soreness at injection site.  Subsequent sudden onset of tingling and weakness in lower extremities as well as light headed was beginning Sept 26, 2023 and progressing rapidly to near paralysis. Diagnosed with Guillaume-Barre Syndrome  October 2, 2023.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Flu-like symptoms for several days starting several hours after the vaccination; also soreness at injection site.  Subsequent sudden onset of tingling and weakness in lower extremities as well as light headed was beginning Sept 26, 2023 and progressing rapidly to near paralysis. Diagnosed with Guillaume-Barre Syndrome  October 2, 2023.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Dizziness, Guillain-Barre syndrome, Influenza like illness, Injection site pain, Lumbar puncture
Clinical narrative: Flu-like symptoms for several days starting several hours after the vaccination; also soreness at injection site.  Subsequent sudden onset of tingling and weakness in lower extremities as well as light headed was beginning Sept 26, 2023 and progressing rapidly to near paralysis. Diagnosed with Guillaume-Barre Syndrome  October 2, 2023.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia
Clinical narrative: Flu-like symptoms for several days starting several hours after the vaccination; also soreness at injection site.  Subsequent sudden onset of tingling and weakness in lower extremities as well as light headed was beginning Sept 26, 2023 and progressing rapidly to near paralysis. Diagnosed with Guillaume-Barre Syndrome  October 2, 2023.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Ascending flaccid paralysis, Back pain, CSF protein increased, CSF white blood cell count negative, Gait inability
Clinical narrative: Flu-like symptoms for several days starting several hours after the vaccination; also soreness at injection site.  Subsequent sudden onset of tingling and weakness in lower extremities as well as light headed was beginning Sept 26, 2023 and progressing rapidly to near paralysis. Diagnosed with Guillaume-Barre Syndrome  October 2, 2023.
Age: 67.0
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Flu-like symptoms for several days starting several hours after the vaccination; also soreness at injection site.  Subsequent sudden onset of tingling and weakness in lower extremities as well as light headed was beginning Sept 26, 2023 and progressing rapidly to near paralysis. Diagnosed with Guillaume-Barre Syndrome  October 2, 2023.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Injection site pain, Joint noise
Clinical narrative: right shoulder has been painful since injection with popping and clinking with movement. weakness due to pain
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: No adverse event
Clinical narrative: During interpretation understood patient had not had the vaccine or the disease.  Upon discussing  the other child's vaccines and the need for varicella immunization the mom stated she " that both of the girls may have had chicken pox at the same time".  Vaccine had already been administered to one when being asked about the disease at the beginning of the visit and reviewing the vaccines needed to today.  No side effects, the parent verbalized understanding that this will not do harm but was an unnecessary vaccine.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Pyrexia, Vomiting
Clinical narrative: Abdominal pain, vomiting, fever
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Feeling abnormal, Pyrexia
Clinical narrative: 2 days after the vaccine (NOTE - he got the high dose flu at the same time) he developed generalized weakenss, low grade fevers, no enerty and feels poorly
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hypersensitivity, Malaise, Rash
Clinical narrative: Patient stated that she received the Flu shot on 09/25/2023 and by later that afternoon she began experiencing an allergic reaction, stated this rash is all over her body, especially at the joints of her knees, thigh, elbow and stomach. Says she is also feeling very sick. Indicated that she has been using some Benadryl and the rash has been improving some. She will continue to treat her symptoms with the Benadryl and is instructed to call back if things do not continue to improve or to come in if needs to be seen.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Drug hypersensitivity, Erythema, Pruritus, Skin warm
Clinical narrative: localized swelling, redness, hot to touch, and slight itch starting within 24 hours of injection. Increased in severity over the following 72 hours. Patient took Advil with no relief.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Flu vaccine rec'd 9/29/23 at 1345 in left arm, at flu clinic.  No issues initially.  On Monday at 0300am, woke up very itchy all over. When woke again at 0600aam, has hives from knees to shoulders over all areas, red raised and very itchy. Seemed to go away on Tues and Wed. Woke up 0300 today, 10/6/23, and hives again in same areas looking the same. Pt took Benadryl around 0700.  Calmed the itch, hives no longer elevated, but still red and patchy.   Does not feel needs medical care at this time, but aware to seek care if sx worsen or new Sx appear.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Flu vaccine rec'd 9/29/23 at 1345 in left arm, at flu clinic.  No issues initially.  On Monday at 0300am, woke up very itchy all over. When woke again at 0600aam, has hives from knees to shoulders over all areas, red raised and very itchy. Seemed to go away on Tues and Wed. Woke up 0300 today, 10/6/23, and hives again in same areas looking the same. Pt took Benadryl around 0700.  Calmed the itch, hives no longer elevated, but still red and patchy.   Does not feel needs medical care at this time, but aware to seek care if sx worsen or new Sx appear.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate vaccine given, no adverse events
Age: 63.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received 65+ dose of vaccine. No advise side effects. Physician and pt aware at time of administration.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: CSF test normal, Cerebral disorder, Dysstasia, Fatigue, Gait inability
Clinical narrative: Woke the morning of 9/25/2023 with c/o bilateral leg pain, fatigue, inability to stand/ambulate, and incontinent of urine. Later in the day had urinary retention.  Hospitalized. Treated with  Solu-medrol, Gabapentin, Azithromycin.  The child did have a cold 2-3 weeks prior to the neurological symptoms.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Mycoplasma test positive, Nasopharyngitis, Neurological symptom
Clinical narrative: Woke the morning of 9/25/2023 with c/o bilateral leg pain, fatigue, inability to stand/ambulate, and incontinent of urine. Later in the day had urinary retention.  Hospitalized. Treated with  Solu-medrol, Gabapentin, Azithromycin.  The child did have a cold 2-3 weeks prior to the neurological symptoms.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pain in extremity, Spinal cord disorder, Urinary incontinence, Urinary retention
Clinical narrative: Woke the morning of 9/25/2023 with c/o bilateral leg pain, fatigue, inability to stand/ambulate, and incontinent of urine. Later in the day had urinary retention.  Hospitalized. Treated with  Solu-medrol, Gabapentin, Azithromycin.  The child did have a cold 2-3 weeks prior to the neurological symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site warmth, Nausea, Pyrexia
Clinical narrative: AT 5PM STARTED HAVING HEADACHE, FEVER, CHILLS AND NAUSEA WITH NO EMESIS.  AT INJECTION SITE SHE STATED IT WAS "HOT"
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Pruritus, Rash, Urticaria
Clinical narrative: Pt was given flu shot at clinic around 9am today at flu clinic. Pt returned to flu clinic around 1:30pm and that she had started to notice about an hour or two after she received her vaccine that she was itching on her face/neck and had some hives/rash on her arm and redness at the injection site. Left side of pt's face appeared to be slightly red on cheek and chin area where she had scratched and there was some redness at the injection site on left arm. No difficulty breathing observed and pt was alert and oriented. She states that she has never had any type of reaction in the past to the flu vaccine, gets them yearly and is not allergic to eggs. Pt was given 2 Benadryls, she has no drug allergies. Pt was instructed to return to clinic if any of her symptoms worsen after she takes Benadryls and was instructed not to drive due to side effects of Benadryls. She states she normally takes an anti-histamine every morning for allergies but did not take one this morning. She also asked if she would be exempt from receiving a flu vaccine in the future. I explained that flu medical exemptions are approved for severe anaphylactic reactions and an flu medical exemption form would need to be signed by an MD and would need medical records from treatment of the reaction. Pt did not return to flu clinic after Benadryl given.