chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Hypokalaemia, Laboratory test normal, Lung opacity, Malaise
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "94-year-old female past medical history of hypertension and hyperlipidemia who presented with 4 day onset of sore throat, increased secretions, and generalized malaise.  Upon arrival to the emergency department, she was afebrile, hemodynamically stable, and maintaining adequate oxygenation on room air.  Viral respiratory panel was positive for COVID-19, otherwise negative.  Other initial intake lab work was unremarkable, including sputum culture. CXR showed subtle interstitial opacities raise concern for COVID pneumonia.  She was provided supportive care including scheduled DuoNeb treatments, no steroids nor antivirals were given.  Overnight, she demonstrated improvement in her presenting symptoms without developing any worsening respiratory distress nor acute hypoxic respiratory failure.  She was medically optimized and subsequently discharged home in stable condition.   Hospital Course:    This 94-year-old female with a medical history of hypertension and hyperlipidemia presents with generalized body aches, weakness, and cough, COVID-19 rapid PCR positive.   COVID-19 Infection - suspect viral syndrome causing her generalized body aches and weakness - symptom onset 12/8/2022 - Respiratory panel only positive for COVID-19, otherwise negative - no known risk factors for decompensation - maintained adequate oxygenation at room air, afebrile, 0/4 SIRS criteria - supportive care - sputum sample collected and showed normal oropharyngeal flora - scheduled Duonebs twice daily - severe isolation precautions   Hypertension - resume benazepril given hemodynamic stability overnight, BP above goal   Chronic BLE edema - holding lasix on discharge for concern of limited oral intake with active infection   Hyperlipidemia - not on statin   Osteopenia - noted on DEXA scan 8/4/2021 with low bone mass in bilateral hips - calcium and vitamin D3 supplementation   Hypokalemia - trend, supplemented as needed   Constipation - Bowel regimen   History of iron deficiency anemia - hold supplemental iron in setting of infection   Chronic arthralgias, back pain - hold home ASA 325 mg daily, discontinued on discharge - lidocaine patch PRN"
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema peripheral, Oropharyngeal pain, Pain, Respiratory viral panel, SARS-CoV-2 test positive
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "94-year-old female past medical history of hypertension and hyperlipidemia who presented with 4 day onset of sore throat, increased secretions, and generalized malaise.  Upon arrival to the emergency department, she was afebrile, hemodynamically stable, and maintaining adequate oxygenation on room air.  Viral respiratory panel was positive for COVID-19, otherwise negative.  Other initial intake lab work was unremarkable, including sputum culture. CXR showed subtle interstitial opacities raise concern for COVID pneumonia.  She was provided supportive care including scheduled DuoNeb treatments, no steroids nor antivirals were given.  Overnight, she demonstrated improvement in her presenting symptoms without developing any worsening respiratory distress nor acute hypoxic respiratory failure.  She was medically optimized and subsequently discharged home in stable condition.   Hospital Course:    This 94-year-old female with a medical history of hypertension and hyperlipidemia presents with generalized body aches, weakness, and cough, COVID-19 rapid PCR positive.   COVID-19 Infection - suspect viral syndrome causing her generalized body aches and weakness - symptom onset 12/8/2022 - Respiratory panel only positive for COVID-19, otherwise negative - no known risk factors for decompensation - maintained adequate oxygenation at room air, afebrile, 0/4 SIRS criteria - supportive care - sputum sample collected and showed normal oropharyngeal flora - scheduled Duonebs twice daily - severe isolation precautions   Hypertension - resume benazepril given hemodynamic stability overnight, BP above goal   Chronic BLE edema - holding lasix on discharge for concern of limited oral intake with active infection   Hyperlipidemia - not on statin   Osteopenia - noted on DEXA scan 8/4/2021 with low bone mass in bilateral hips - calcium and vitamin D3 supplementation   Hypokalemia - trend, supplemented as needed   Constipation - Bowel regimen   History of iron deficiency anemia - hold supplemental iron in setting of infection   Chronic arthralgias, back pain - hold home ASA 325 mg daily, discontinued on discharge - lidocaine patch PRN"
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Secretion discharge, Sputum culture, Viral infection
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "94-year-old female past medical history of hypertension and hyperlipidemia who presented with 4 day onset of sore throat, increased secretions, and generalized malaise.  Upon arrival to the emergency department, she was afebrile, hemodynamically stable, and maintaining adequate oxygenation on room air.  Viral respiratory panel was positive for COVID-19, otherwise negative.  Other initial intake lab work was unremarkable, including sputum culture. CXR showed subtle interstitial opacities raise concern for COVID pneumonia.  She was provided supportive care including scheduled DuoNeb treatments, no steroids nor antivirals were given.  Overnight, she demonstrated improvement in her presenting symptoms without developing any worsening respiratory distress nor acute hypoxic respiratory failure.  She was medically optimized and subsequently discharged home in stable condition.   Hospital Course:    This 94-year-old female with a medical history of hypertension and hyperlipidemia presents with generalized body aches, weakness, and cough, COVID-19 rapid PCR positive.   COVID-19 Infection - suspect viral syndrome causing her generalized body aches and weakness - symptom onset 12/8/2022 - Respiratory panel only positive for COVID-19, otherwise negative - no known risk factors for decompensation - maintained adequate oxygenation at room air, afebrile, 0/4 SIRS criteria - supportive care - sputum sample collected and showed normal oropharyngeal flora - scheduled Duonebs twice daily - severe isolation precautions   Hypertension - resume benazepril given hemodynamic stability overnight, BP above goal   Chronic BLE edema - holding lasix on discharge for concern of limited oral intake with active infection   Hyperlipidemia - not on statin   Osteopenia - noted on DEXA scan 8/4/2021 with low bone mass in bilateral hips - calcium and vitamin D3 supplementation   Hypokalemia - trend, supplemented as needed   Constipation - Bowel regimen   History of iron deficiency anemia - hold supplemental iron in setting of infection   Chronic arthralgias, back pain - hold home ASA 325 mg daily, discontinued on discharge - lidocaine patch PRN"
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Electrocardiogram, Eye disorder, Migraine, Speech disorder
Clinical narrative: On 11/17 I started having abnormal vision and having trouble speaking. I drove myself to the ER where it was determined that it was a migraine. I had a CT scan; EKG and ECG. I was referred to a Retina Specialist as I had fluid in my eye. I have had one injection of LUCENTIS directly into my eye. And will most likely have a second injection when I have a follow up appointment with the Retina Specialist on 01/04/2023. I have seen an Ophthalmologist; Retina Specialist and all have contradictory diagnosis for my condition. I also have a follow up with the Ophthalmologist as well.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Visual impairment
Clinical narrative: On 11/17 I started having abnormal vision and having trouble speaking. I drove myself to the ER where it was determined that it was a migraine. I had a CT scan; EKG and ECG. I was referred to a Retina Specialist as I had fluid in my eye. I have had one injection of LUCENTIS directly into my eye. And will most likely have a second injection when I have a follow up appointment with the Retina Specialist on 01/04/2023. I have seen an Ophthalmologist; Retina Specialist and all have contradictory diagnosis for my condition. I also have a follow up with the Ophthalmologist as well.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of high dose fluzone 20 minutes after receiving the first dose.  two different staff members administered 20 minutes apart, one in the right arm, one in the left arm.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test normal, Fatigue, Feeling abnormal
Clinical narrative: Persistent significant, overwhelming  fatigue.  This occurs usually after moderate to light physical activity.  Occasional brain fog  also occurs.        This condition also occurred after a Pfizer booster given on 4/19/22 but that time instance went away after 3 months.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Gardasil 9 given instead of flu vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 11/30/2022
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood sodium decreased, Breath sounds abnormal, COVID-19, Herpes simplex
Clinical narrative: Patient with 4 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "68 year old female PMH of COPD, hypertension, hypothyroidism presented to the ED with generalized weakness and upper respiratory symptoms found to be COVID-19+. During admission, patient was found to have hyponatremia likely 2/2 to hypovolemia with sodium level of 120, corrected to 137 12/14. Patient received 2 doses of remdesivir and short course of dexamethasone. Patient was initially accepted to SNF however due to clinical improvement will go home with home assist at this time. Patient to complete 5 day course of acyclovir for HSV-1 lesion in her nose, that has since resolved.   Constitutional - non-ill appearing (improving). Laying in bed comfortably HEENT - normocephalic atraumatic Cardiovascular - RRR.  No pedal edema noted bilaterally Pulmonary - coarse breath sounds bilaterally (unchanged) Abdominal - soft without tenderness  Extremities - no motor deficits, skin warm/dry Neurological - alert and oriented with no focal deficits     Hospital Course: COVID-19 Infection Generalized weakness 2/2 to above -Symptom onset 12/1 s/p 2 doses remdesivir, dexamethasoneX5days -Continue mucinex, incentive spirometry -OT recommending home independently 12/13, will send with home with assist."
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hyponatraemia, Hypovolaemia, Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: Patient with 4 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "68 year old female PMH of COPD, hypertension, hypothyroidism presented to the ED with generalized weakness and upper respiratory symptoms found to be COVID-19+. During admission, patient was found to have hyponatremia likely 2/2 to hypovolemia with sodium level of 120, corrected to 137 12/14. Patient received 2 doses of remdesivir and short course of dexamethasone. Patient was initially accepted to SNF however due to clinical improvement will go home with home assist at this time. Patient to complete 5 day course of acyclovir for HSV-1 lesion in her nose, that has since resolved.   Constitutional - non-ill appearing (improving). Laying in bed comfortably HEENT - normocephalic atraumatic Cardiovascular - RRR.  No pedal edema noted bilaterally Pulmonary - coarse breath sounds bilaterally (unchanged) Abdominal - soft without tenderness  Extremities - no motor deficits, skin warm/dry Neurological - alert and oriented with no focal deficits     Hospital Course: COVID-19 Infection Generalized weakness 2/2 to above -Symptom onset 12/1 s/p 2 doses remdesivir, dexamethasoneX5days -Continue mucinex, incentive spirometry -OT recommending home independently 12/13, will send with home with assist."
Age: 88.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anti-glomerular basement membrane antibody, Antineutrophil cytoplasmic antibody positive, Bedridden, Influenza like illness, Renal failure
Clinical narrative: flue like symptoms, bedridden for two weeks at home, visit to emergency room led to admission in hospital, diagnosis kidney failure. three weeks in the hospital now with several Predinizone and infustion treaments underway. STILL IN HOSPITAL!!
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Syringe issue
Clinical narrative: Pharmaceutical product complaint; did not received a full dose because of a malfunction; 12 months old received 4th dose of DTap; malfunction with a syringe; This case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 12-month-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 30th March 2024) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 6th December 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inappropriate age at vaccine administration and syringe issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, inappropriate age at vaccine administration, syringe issue and pharmaceutical product complaint were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Doctor had a malfunction with a syringe of Infanrix, and a child did not receive a full dose. Infanrix was the patients 4th dose of DTaP The reporter consent to follow up via email. Additional Supportive Information: The patient did not receive full dose of Infanrix vaccine due to malfunction of syringe at age of 12 months, which led to incomplete dose administered, inappropriate age at vaccine administration and syringe issue.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Coronavirus infection, Coronavirus test positive, Cough
Clinical narrative: Tested positive for coronavirus on a home test; only very mild symptom (light cough); no fever; no sore throat; no other symptoms; prescribed Paxlovid after a call with my primary care physician; symptoms ended in a very short time, and I tested negative twice across 48 hours in home tests, 3 days and 5 days after initial positive test, and 2 days and 4 days after beginning Paxlovid.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Palpitations, Rash
Clinical narrative: Palpitations, chest pain, dyspnea, rash
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 52.0
Sex: F
Vaccine: HEP, TDAP, VARZOS
Symptoms: Adverse drug reaction, Headache, Herpes zoster, Inflammation
Clinical narrative: The day of the vaccine, started have headache and "everything the [VIS] has about side effects." And continues to have symptoms that are becoming worse. States shingles infection to back started two weeks after injections.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The pharmacist reported that the patient wanted to schedule a second dose of Shingrix but that the first dose had been received on year 2019.  According to the patient, the first dose was received in 2009 even though Shingrix was approved later. Information on first dose was not available since it was administered in another facility. The vaccine administration facility was the same as primary reporter. The VAERS details given for the first dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Dermatitis allergic, Dizziness, Photosensitivity reaction
Clinical narrative: I experienced dizziness and I was diagnosed with photo allergic dermatitis.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: A couple hours after receiving the Pfizer Booster, I started to experience my heart rate accelerating while resting. This continued into the next day, but after that, it stopped. It never occurred again after the next day.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 12/12/2022
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLU4, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was to receive monovalent Covid Pfizer vaccine for 1st dose in series.  Pt inadvertently was given the bivalent booster instead of 1st dose monovalent.  No adverse outcome, however we will give him his 2nd monovalent dose as per regular course, and continue regular course moving forward.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Chills, Headache, Hypersomnia
Clinical narrative: I woke up Tuesday morning with a slight sore throat. As the day went on, I felt feverish, but I did not have a fever, I did take it. I went to bed and slept eleven hours. When I woke up, I had a runny nose, felt feverish, chills, body aches, slight headache. We were driving back from a camping trip and even with all that rest I did not feel like I could drive. I had my wife drive the other half of the trip. Once we got home, once home I took a home COVID-19 test that came back positive, I took my temperature and had a low-grade fever. I called my primary care physician who prescribed Paxlovid that I started taking immediately. I am on day two and I only have a runny nose and have a bit more energy.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Impaired driving ability, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: I woke up Tuesday morning with a slight sore throat. As the day went on, I felt feverish, but I did not have a fever, I did take it. I went to bed and slept eleven hours. When I woke up, I had a runny nose, felt feverish, chills, body aches, slight headache. We were driving back from a camping trip and even with all that rest I did not feel like I could drive. I had my wife drive the other half of the trip. Once we got home, once home I took a home COVID-19 test that came back positive, I took my temperature and had a low-grade fever. I called my primary care physician who prescribed Paxlovid that I started taking immediately. I am on day two and I only have a runny nose and have a bit more energy.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I woke up Tuesday morning with a slight sore throat. As the day went on, I felt feverish, but I did not have a fever, I did take it. I went to bed and slept eleven hours. When I woke up, I had a runny nose, felt feverish, chills, body aches, slight headache. We were driving back from a camping trip and even with all that rest I did not feel like I could drive. I had my wife drive the other half of the trip. Once we got home, once home I took a home COVID-19 test that came back positive, I took my temperature and had a low-grade fever. I called my primary care physician who prescribed Paxlovid that I started taking immediately. I am on day two and I only have a runny nose and have a bit more energy.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient received bivalent booster on 11/3/2022.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthritis, COVID-19, Cellulitis, Cough, Exposure to SARS-CoV-2
Clinical narrative: Caring for my wife who was COVID-19 positive and I began feeling poorly on 11/3. Symptoms were aches, pains, fatigue, respiratory difficulties, and trouble sleeping. Tested positive for COIVD-19 on 11/4 and was prescribed Paxlovid. Symptoms began resolving over the next couple days. Had one day of feeling better and then began experiencing rebound symptoms.  Rebound symptoms were aches, pains, fatigue, respiratory difficulties, and trouble sleeping. Also began having swelling of eyelid and swelling around my eye. Went to doctor and she said she thought it was cellulitis. Prescribed augmentin for 7 days and symptoms of eye issues began resolving quickly. Experienced GI sensitivity at end of course of Augmentin but have never previously had issues with Augmentin. Symptoms and fatigue have greatly improved still experiencing lingering cough. Was taking flonase early on during my COVID-19 infection and seemed to have less severe symptoms than my wife who was sick at the same time.  Arthritis symptoms have resolved since COVID-19 infection and subsequent taking of Paxlovid and arthritis has not returned.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Gastrointestinal disorder, Insomnia, Pain
Clinical narrative: Caring for my wife who was COVID-19 positive and I began feeling poorly on 11/3. Symptoms were aches, pains, fatigue, respiratory difficulties, and trouble sleeping. Tested positive for COIVD-19 on 11/4 and was prescribed Paxlovid. Symptoms began resolving over the next couple days. Had one day of feeling better and then began experiencing rebound symptoms.  Rebound symptoms were aches, pains, fatigue, respiratory difficulties, and trouble sleeping. Also began having swelling of eyelid and swelling around my eye. Went to doctor and she said she thought it was cellulitis. Prescribed augmentin for 7 days and symptoms of eye issues began resolving quickly. Experienced GI sensitivity at end of course of Augmentin but have never previously had issues with Augmentin. Symptoms and fatigue have greatly improved still experiencing lingering cough. Was taking flonase early on during my COVID-19 infection and seemed to have less severe symptoms than my wife who was sick at the same time.  Arthritis symptoms have resolved since COVID-19 infection and subsequent taking of Paxlovid and arthritis has not returned.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Periorbital swelling, Respiratory disorder, SARS-CoV-2 test positive, Swelling of eyelid, Symptom recurrence
Clinical narrative: Caring for my wife who was COVID-19 positive and I began feeling poorly on 11/3. Symptoms were aches, pains, fatigue, respiratory difficulties, and trouble sleeping. Tested positive for COIVD-19 on 11/4 and was prescribed Paxlovid. Symptoms began resolving over the next couple days. Had one day of feeling better and then began experiencing rebound symptoms.  Rebound symptoms were aches, pains, fatigue, respiratory difficulties, and trouble sleeping. Also began having swelling of eyelid and swelling around my eye. Went to doctor and she said she thought it was cellulitis. Prescribed augmentin for 7 days and symptoms of eye issues began resolving quickly. Experienced GI sensitivity at end of course of Augmentin but have never previously had issues with Augmentin. Symptoms and fatigue have greatly improved still experiencing lingering cough. Was taking flonase early on during my COVID-19 infection and seemed to have less severe symptoms than my wife who was sick at the same time.  Arthritis symptoms have resolved since COVID-19 infection and subsequent taking of Paxlovid and arthritis has not returned.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2020, 2nd 05Dec2022; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in 2020).   On 5th December 2022, the patient received the 2nd dose of Shingrix. On 5th December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: The reporter had a 66 year old patient who received his first dose of Shingrix in 2020.  He received his second dose yesterday (from date of reporting).  The reporter asked if he should receive another dose in 2-6 months or not. The reporter requested guidance on dosing for patients were unable to complete the 2-dose series within the indicated time frame. No Follow up requested in the message, no lot number or vaccine expiration date provided. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine yesterday after receiving 1st dose in 2020, later than the recommended standard schedule, which led to lengthening of the vaccination schedule.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Strong flu-like symptoms, severe joint aches, chills, headache,exhaustion, soreness at location of the shot, this has lasted 2 days, though abating today after 49 hours still have mild joint aches, lack of energy.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Strong flu-like symptoms, severe joint aches, chills, headache,exhaustion, soreness at location of the shot, this has lasted 2 days, though abating today after 49 hours still have mild joint aches, lack of energy.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, COVID-19, Cardiac operation, Cough, Decreased appetite
Clinical narrative: On November 7th, 2022 I was hospitalized for two days recovering from Cardiac procedures. While home convalescing I developed respiratory symptoms in the evening hours on November 20th, 2022. On November 22nd, I was swabbed and received positive COVID-19 and negative for Flu and RSV. I had hoarseness of voice, runny nose, congestion, which increased greatly and continues to plague me. The runny nose resolved a day or so ago. I still have a cough and nasal congestion, which varies in severity and sometimes effects my breathing due to the congestion. I continued to have abdominal discomfort, loss of appetite, weight loss, and fatigue.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphonia, Dyspnoea, Fatigue, Influenza virus test negative, Nasal congestion
Clinical narrative: On November 7th, 2022 I was hospitalized for two days recovering from Cardiac procedures. While home convalescing I developed respiratory symptoms in the evening hours on November 20th, 2022. On November 22nd, I was swabbed and received positive COVID-19 and negative for Flu and RSV. I had hoarseness of voice, runny nose, congestion, which increased greatly and continues to plague me. The runny nose resolved a day or so ago. I still have a cough and nasal congestion, which varies in severity and sometimes effects my breathing due to the congestion. I continued to have abdominal discomfort, loss of appetite, weight loss, and fatigue.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory symptom, Respiratory syncytial virus test negative, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On November 7th, 2022 I was hospitalized for two days recovering from Cardiac procedures. While home convalescing I developed respiratory symptoms in the evening hours on November 20th, 2022. On November 22nd, I was swabbed and received positive COVID-19 and negative for Flu and RSV. I had hoarseness of voice, runny nose, congestion, which increased greatly and continues to plague me. The runny nose resolved a day or so ago. I still have a cough and nasal congestion, which varies in severity and sometimes effects my breathing due to the congestion. I continued to have abdominal discomfort, loss of appetite, weight loss, and fatigue.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Weight decreased
Clinical narrative: On November 7th, 2022 I was hospitalized for two days recovering from Cardiac procedures. While home convalescing I developed respiratory symptoms in the evening hours on November 20th, 2022. On November 22nd, I was swabbed and received positive COVID-19 and negative for Flu and RSV. I had hoarseness of voice, runny nose, congestion, which increased greatly and continues to plague me. The runny nose resolved a day or so ago. I still have a cough and nasal congestion, which varies in severity and sometimes effects my breathing due to the congestion. I continued to have abdominal discomfort, loss of appetite, weight loss, and fatigue.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I had COVID-19 and I had sinus pressure, head cold symptoms, sore throat, loss of taste and smell.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, SARS-CoV-2 test positive
Clinical narrative: I had COVID-19 and I had sinus pressure, head cold symptoms, sore throat, loss of taste and smell.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Echocardiogram normal, Inflammation, Kawasaki's disease, Pharyngeal erythema
Clinical narrative: Kawasaki disease, inflammation, oropharyngeal erythema, conjunctivitis, rash, fever x6 days
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Kawasaki disease, inflammation, oropharyngeal erythema, conjunctivitis, rash, fever x6 days
Age: 0.42
Sex: F
Vaccine: COVID19, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction occurred. COVID vaccine was administered on 11/14/22 when the patient was 5 months and 25 days, 6 days prior to the authorized starting age for COVID-19 vaccines. Reported spoke with CDC on 12/16/22 and was recommended not to repeat dose until patient reaches authorized age and to delay second dose until 8 weeks after invalid dose was administered.
Age: 83.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Nausea, Vomiting
Clinical narrative: Patient came to the ED with complaints of nause, vomiting, and low sPO2.  Pateint was admitted to the hospital with Covid pneumonia and treated with remdesivir.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 12/10/2022
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Decreased appetite, Dizziness, Headache
Clinical narrative: I had intense nausea, no appetite with a low-grade fever with chills. I was warm to the touch with a headache. I felt achy all cover with a cough. My pulse was faster than usual, and I was very lightheaded. I was very irritable.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Irritability, Nausea, Pain, Pyrexia
Clinical narrative: I had intense nausea, no appetite with a low-grade fever with chills. I was warm to the touch with a headache. I felt achy all cover with a cough. My pulse was faster than usual, and I was very lightheaded. I was very irritable.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin warm
Clinical narrative: I had intense nausea, no appetite with a low-grade fever with chills. I was warm to the touch with a headache. I felt achy all cover with a cough. My pulse was faster than usual, and I was very lightheaded. I was very irritable.
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 66 YO received Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 66-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 17th October 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: HCP states that a 66 year old immunocompromised patient was administered Bexsero. She classified the immunosuppressed patient as HIV. No lot number or expiration date available.  The reporter did not verify what that meant.  The reporter consented to follow up via postal. Additional Supportive Information: The 66 year old immunocompromised patient was administered Bexsero, which led to inappropriate age at vaccine administration.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Extrasystoles, Heart rate increased, Heart rate irregular
Clinical narrative: After I had my vaccine, I came home and my heart was all over the place.  It was beating fast and hard and skipping beats.  I was uncomfortable.  I tried drinking water and switching positions.  I did have online conversation with my doctor's office via patient portal online but didn't do anything else.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Fatigue, SARS-CoV-2 test positive
Clinical narrative: I went out to visit my daughter and family. We thought my granddaughter had been exposed to influenza A. I was extremely tired, and I had thought it was from all of the flying. My daughter called me on Saturday to let me know my granddaughter had tested positive for COVID-19. I took a home COVID-19 test that came back positive, I had to wait until Monday to call my doctor who then prescribed Paxlovid that I started immediately. I am feeling much better.
Age: 46.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Antibody test abnormal, Asthenia, Blood test abnormal, Blood thyroid stimulating hormone decreased, Goitre
Clinical narrative: I never had issues with my thyroid.  I began losing weight and feeling weak.  on November1, 2022, 2 weeks post vaccine, I saw my doctor. My doctor thought I had the flu and I did not.  Tests indicated Hypothyroidism.  I have enlarged thyroid.  My antibody levels are high.  I continue to have issues.  I suspect the booster contributed to the issue.  I called Moderna yesterday.
Age: 46.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Hypothyroidism, Influenza virus test negative, Weight decreased
Clinical narrative: I never had issues with my thyroid.  I began losing weight and feeling weak.  on November1, 2022, 2 weeks post vaccine, I saw my doctor. My doctor thought I had the flu and I did not.  Tests indicated Hypothyroidism.  I have enlarged thyroid.  My antibody levels are high.  I continue to have issues.  I suspect the booster contributed to the issue.  I called Moderna yesterday.
Age: 46.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Electrocardiogram, Hyperthyroidism, Thyroxine
Clinical narrative: I never had issues with my thyroid.  I began losing weight and feeling weak.  on November1, 2022, 2 weeks post vaccine, I saw my doctor. My doctor thought I had the flu and I did not.  Tests indicated Hypothyroidism.  I have enlarged thyroid.  My antibody levels are high.  I continue to have issues.  I suspect the booster contributed to the issue.  I called Moderna yesterday.
Age: 46.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Tri-iodothyronine
Clinical narrative: I never had issues with my thyroid.  I began losing weight and feeling weak.  on November1, 2022, 2 weeks post vaccine, I saw my doctor. My doctor thought I had the flu and I did not.  Tests indicated Hypothyroidism.  I have enlarged thyroid.  My antibody levels are high.  I continue to have issues.  I suspect the booster contributed to the issue.  I called Moderna yesterday.
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 68.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: headacke. stomick acke  day2. headacke, seveie stomick acke where it double me over day 3,4,5 feel like i have flu,headacke, body acke and tiredness
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Client administered bivalent vaccine as second dose of primary series.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: On 12/10/2022 I test positive for COVID-19. I had a sore throat; headache;low grade fever ( 100.0 )My symptoms lasted 5 days. I took  OTC pain relievers as needed.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Client administered a bivalent dose as first dose of primary series.
Age: 85.0
Sex: M
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest pain, Cough, Discomfort, Dyspnoea
Clinical narrative: I received the Pfizer Bivalent booster on 11/17/2022. On 11/28/2022, I had a severe headache and a little bit of nausea. I took some hydrocodone and promethazine. They didn't get rid of the headache, but the promethazine did take away the nausea. After I took the medicines, I just slept, because there was nothing else to do. During the week of 11/28/2022 to 12/2/2022, the symptoms got progressively worse. On 11/30/2022, I had persistent chest pains. On that day, I had a telehealth visit with a PA who works with my pulmonologist. She agreed to ask my pulmonologist to prescribe me some prednisone. At this point, I had taken a home antigen test every day between 11/27/2022 and 11/30/2022 and had gotten a negative result each time. However, my wife had tested positive, so the PA felt pretty confident that I also had it, despite the results of the tests. On 12/1/2022, I took another home antigen test and got a positive result. The symptoms I was dealing with during this time included difficulty breathing, body aches, severe cough, chest pains, nasal congestion, and nausea. I had to use my rescue inhaler when I had difficulty breathing; the inhaler helped somewhat, but not completely. On 12/1/2022, I finally got a prescription for prednisone, Z-PAK, and promethazine, and I began taking the prednisone and the Z-PAK on 12/2/2022. On the night of 12/2/2022, the chest pains had diminished somewhat, so I had less discomfort. At the time of this writing, I continue to have chest pains, which are now somewhat intermittent and are much milder than they were at the beginning of my illness. I also continue to have a persistent (but milder) headache, a mild cough, and intermittent nausea. Of all those, I would say that nausea is the worst symptom, but it now seems to be diminishing. On 12/13/2022, I took another home antigen test and got a positive result. When I took another antigen test on 12/15/2022, I finally got a negative result for the first time since the beginning of my illness.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Exposure to SARS-CoV-2, Headache, Nasal congestion, Nausea, Pain
Clinical narrative: I received the Pfizer Bivalent booster on 11/17/2022. On 11/28/2022, I had a severe headache and a little bit of nausea. I took some hydrocodone and promethazine. They didn't get rid of the headache, but the promethazine did take away the nausea. After I took the medicines, I just slept, because there was nothing else to do. During the week of 11/28/2022 to 12/2/2022, the symptoms got progressively worse. On 11/30/2022, I had persistent chest pains. On that day, I had a telehealth visit with a PA who works with my pulmonologist. She agreed to ask my pulmonologist to prescribe me some prednisone. At this point, I had taken a home antigen test every day between 11/27/2022 and 11/30/2022 and had gotten a negative result each time. However, my wife had tested positive, so the PA felt pretty confident that I also had it, despite the results of the tests. On 12/1/2022, I took another home antigen test and got a positive result. The symptoms I was dealing with during this time included difficulty breathing, body aches, severe cough, chest pains, nasal congestion, and nausea. I had to use my rescue inhaler when I had difficulty breathing; the inhaler helped somewhat, but not completely. On 12/1/2022, I finally got a prescription for prednisone, Z-PAK, and promethazine, and I began taking the prednisone and the Z-PAK on 12/2/2022. On the night of 12/2/2022, the chest pains had diminished somewhat, so I had less discomfort. At the time of this writing, I continue to have chest pains, which are now somewhat intermittent and are much milder than they were at the beginning of my illness. I also continue to have a persistent (but milder) headache, a mild cough, and intermittent nausea. Of all those, I would say that nausea is the worst symptom, but it now seems to be diminishing. On 12/13/2022, I took another home antigen test and got a positive result. When I took another antigen test on 12/15/2022, I finally got a negative result for the first time since the beginning of my illness.