chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinus disorder
Clinical narrative: I tested positive for COVID-19. I had a fever, aches, and chills. I had a video visit with my doctor, and they prescribed me Paxlovid. I started feeling better and tested negative for COVID-19. Two days later I started having sinus problems and I tested positive for COVID-19 again.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Electrocardiogram abnormal, Fatigue, Heart rate decreased, Myocardial infarction
Clinical narrative: I had my vaccination on 10/03/2022. On 02/14/2023 I had an EKG. I was referred to a Cardiologist.  I was informed I had increased blood pressure and low resting heart rate. On 02/14/2023 I was told that I had had a heart attack in the past. I do have follow up appointments in 04/2023. I have a stress test scheduled for 04/05/2023 and the resting test to be done on 04/06/2023. I do have extreme fatigue presently on 04/04/2023. I did test COVID-19 Positive 04/2022.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiogenic shock, Deep vein thrombosis, Hypotension, Hypothyroidism
Clinical narrative: I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/24/2022 HYPOTHYROIDISM I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/31/2022 HYPOTHYROIDISM I95.9 HYPOTENSION 1/24/2022 HYPOTHYROIDISM J96.00 ACUTE RESPIRATORY FAILURE 3/8/2022 HYPOTHYROIDISM R57.0 CARDIOGENIC SHOCK 1/24/2022 HYPOTHYROIDISM
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/24/2022 HYPOTHYROIDISM I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/31/2022 HYPOTHYROIDISM I95.9 HYPOTENSION 1/24/2022 HYPOTHYROIDISM J96.00 ACUTE RESPIRATORY FAILURE 3/8/2022 HYPOTHYROIDISM R57.0 CARDIOGENIC SHOCK 1/24/2022 HYPOTHYROIDISM
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Malaise, Nasopharyngitis, Odynophagia
Clinical narrative: On 3/22/2023, I had quite a bit of coughing and a low-grade fever. I then developed a sore throat that had a sharpness whenever I swallowed. I also had the sniffles. I took two home antigen tests, and they both yielded a positive result. I called my doctor's office, and they scheduled a telehealth visit with their NP at 4:00 PM that day. The NP prescribed Paxlovid, which I began taking that evening. I had no side effects from the Paxlovid. The COVID-19 symptoms were like those with a cold with a sore throat. The fever went away pretty quickly. I isolated and worked from home; I had adequate energy for work. I took another home antigen test on 3/28/2023 and got a negative result, and I got another negative result on 3/30/2023. On 4/3/2023, I tested myself again and got a positive result. I saw my NP earlier today, and he thought it might have been a rebound or just a result of a residual trace of the virus. He advised me to wear a mask and to be cautious when I interact with others.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On 3/22/2023, I had quite a bit of coughing and a low-grade fever. I then developed a sore throat that had a sharpness whenever I swallowed. I also had the sniffles. I took two home antigen tests, and they both yielded a positive result. I called my doctor's office, and they scheduled a telehealth visit with their NP at 4:00 PM that day. The NP prescribed Paxlovid, which I began taking that evening. I had no side effects from the Paxlovid. The COVID-19 symptoms were like those with a cold with a sore throat. The fever went away pretty quickly. I isolated and worked from home; I had adequate energy for work. I took another home antigen test on 3/28/2023 and got a negative result, and I got another negative result on 3/30/2023. On 4/3/2023, I tested myself again and got a positive result. I saw my NP earlier today, and he thought it might have been a rebound or just a result of a residual trace of the virus. He advised me to wear a mask and to be cautious when I interact with others.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac arrest, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE 3/23/2021 CARDIAC ARREST DUE TO UNSPECIFIED CAUSE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/27/2021 CARDIAC ARREST DUE TO UNSPECIFIED CAUSE
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Dizziness, Headache
Clinical narrative: I had headache, scratchy sore throat, nausea, light headedness, diarrhea, cough. I took a home COVID-19 test that came back positive, I called my primary care physician, had a telehealth visit and the PAXLOVID. I started taking the antiviral on March 14, 2023. I did start feeling better and testing negative. I then got rebound COVID-19, March 26, 2023. The cough this time around is much worse the congestion is still here, but I have tested negative.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I had headache, scratchy sore throat, nausea, light headedness, diarrhea, cough. I took a home COVID-19 test that came back positive, I called my primary care physician, had a telehealth visit and the PAXLOVID. I started taking the antiviral on March 14, 2023. I did start feeling better and testing negative. I then got rebound COVID-19, March 26, 2023. The cough this time around is much worse the congestion is still here, but I have tested negative.
Age: 50.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Angiogram, Blood test, Computerised tomogram thorax, Dizziness, Loss of consciousness
Clinical narrative: I had weak legs and felt very faint. As time went on. it felt like I was going to have a heart attack. I also blacked out.
Age: 50.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Muscular weakness
Clinical narrative: I had weak legs and felt very faint. As time went on. it felt like I was going to have a heart attack. I also blacked out.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/15/2022 ATRIAL FIBRILLATION, PAROXYSMAL
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Imaging procedure abnormal, Muscular weakness, Rash, Skin disorder
Clinical narrative: Starting in June 2022, I started to developing rashes on my forehead. The rashes increasing to other parts of my face and neck. I started to develop also skin problems on my hands as well. I also developed muscle weakness, particularly on my legs and my upper extremities, my neck and shoulders. I had medical imaging studies due to my symptoms. My diagnoses was dermatitis. My symptoms are improving but I have not recovered.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Lacunar stroke, Neuropathy peripheral, Pneumonia
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 2/28/2022 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/9/2021 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY R09.02 HYPOXIA 4/18/2022 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY G62.9 PERIPHERAL NEUROPATHY 2/28/2022 PNEUMONIA I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/9/2021 PNEUMONIA R09.02 HYPOXIA 4/18/2022 PNEUMONIA
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chemotherapy, Computerised tomogram pelvis, Endometrial cancer, Hysterectomy, Scan
Clinical narrative: It started with heavy vaginal discharge. I decided to go to the clinic to see what that was about; they did an endometriosis ultrasound, swabbing scan and a CT scan. They completed a hysterectomy procedure and additional swabbing for testing when they determined I had endometrial cancer (ferrous carcinoma), or practically uterine cancer. I'm currently undergoing chemotherapy for treatment in hopes of recovery.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Smear vagina, Ultrasound scan, Vaginal discharge
Clinical narrative: It started with heavy vaginal discharge. I decided to go to the clinic to see what that was about; they did an endometriosis ultrasound, swabbing scan and a CT scan. They completed a hysterectomy procedure and additional swabbing for testing when they determined I had endometrial cancer (ferrous carcinoma), or practically uterine cancer. I'm currently undergoing chemotherapy for treatment in hopes of recovery.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Magnetic resonance imaging abnormal, Pneumonia, Pyrexia
Clinical narrative: On 12/03/2022 it started with coughing, low-grade fever. I then sought care from a local clinic (urgent care), and they performed an MRI and I was diagnosed with a lung infection. Provider prescribed LEVAQUIN. I am still short of energy.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Benign prostatic hyperplasia, Hypotension, Respiratory failure
Clinical narrative: Moderna vaccine was administered outside of facility- reported by patient  ACUTE NON ST ELEVATION MI 8/7/2021 BPH (BENIGN PROSTATIC HYPERPLASIA) HYPOTENSION 7/25/2021 BPH (BENIGN PROSTATIC HYPERPLASIA) RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/16/2021 BPH (BENIGN PROSTATIC HYPERPLASIA)
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Lethargy, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: My sinus infection started on 01/28/2023 in the morning. I had a runny nose, nasal congestion, headaches, and lethargic. I went to a local clinic since my doctor was out of town. The prescribed me antibiotics. I also went to another clinic where they advised me to see my regular doctor since mine was mild they advised me to use over the counter medication such as MUCINEX and ibuprofen. I went to my primary care she said it was viral so she prescribe gabapentin 3 times a day. As of today I still have the symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: My sinus infection started on 01/28/2023 in the morning. I had a runny nose, nasal congestion, headaches, and lethargic. I went to a local clinic since my doctor was out of town. The prescribed me antibiotics. I also went to another clinic where they advised me to see my regular doctor since mine was mild they advised me to use over the counter medication such as MUCINEX and ibuprofen. I went to my primary care she said it was viral so she prescribe gabapentin 3 times a day. As of today I still have the symptoms.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse event; HCP reported GARDASIL 9 was administered to a pregnant patient. Caller did not provide any further clarifying details; This spontaneous report was received from a nurse referred to a 29-year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.   On an unknown date, the patient became pregnant. The pregnancy gestation was reported as 29 weeks and 2 days. The last menstrual period (LMP) was estimated was on 20-AUG-2022. On 13-MAR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775811, expiration date: 07-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided) (exposure during pregnancy). The reporter did not provide any further clarifying details. No additional adverse event was reported (No adverse event). The pregnancy outcome was pending and the fetal outcome was unknown at the time of the report. The estimated date of delivery (EDD) was calculated on 27-MAY-2023.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; TE for PROQUAD on 3/27/23 and 1 dose of vaccine administered on 3/30/23; This spontaneous report was received from a registered nurse and refers to a 5-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported.  On 27-MAR-2023, 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) underwent temperature excursion (TE) at 10.62 degrees Fahrenheit for 43 minutes. There was previous temperature excursion for 4 hours and 34 minutes involved. On 30-MAR-2023, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, once, lot #W034211, expiration date: 24-APR-2024 (route of administration was not provided), administered for prophylaxis (product storage error). No additional adverse events (AEs) were reported.
Age: 6.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The caller went on to ask about another AE where a "6 year old patient received meningococcal vaccine and they were outside the age requirements; No additional AE reported.; This spontaneous report has been received from a nurse prescriber, referring a 6-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection (strength, dose, frequency, administration route, lot number, and expiry date were not provided) (product administered to patient of inappropriate age) indicated as prophylaxis.  No additional adverse events were reported.  This is one of several reports received from the same reporter; Sender Comments:  US-009507513-2303USA006657:Original Case : 2303USA006657
Sex: F
Vaccine: MNQ
Symptoms: Anxiety, Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: tingling - issues in both legs; stress; anxiety; Leg weakness; Pain, shooting pain; numbness, Leg numbness; This non-serious case was reported by a consumer and described the occurrence of pain in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28-FEB-2023) for prophylaxis.   Additional patient notes included the patient was a completely healthy individual, no health issues, no injuries, no falls and active soccer player.   On 28-JUL-2022, the patient received Menveo 1 ml. On 31-JUL-2022, 3 days after receiving Menveo, the patient experienced pain (Verbatim: Pain, shooting pain), numbness (Verbatim: numbness, Leg numbness) and lower extremities weakness of (Verbatim: Leg weakness). On an unknown date, the patient experienced tingling (Verbatim: tingling - issues in both legs), stress (Verbatim: stress) and anxiety (Verbatim: anxiety). The outcome of the pain, numbness and lower extremities weakness of were not recovered/not resolved and the outcome of the tingling, stress and anxiety were not reported.   It was unknown if the reporter considered the pain, numbness, tingling, lower extremities weakness of, stress and anxiety to be related to Menveo.     It was unknown if the company considered the pain, numbness, tingling, lower extremities weakness of, stress and anxiety to be related to Menveo.   Additional Information: GSK receipt date: 23-Mar-2023 This report was submitted via the online direct entry reporting system. The patient received a dose of Shingrix and had leg numbness, pain, shooting pain, weakness and tingling issues in both legs.  The reporter reported that when they contacted the physician office on 8th January 2023 inquiring if symptoms could be a side effect from one of the vaccinations received, physician said it was not and most likely stress or anxiety etc.  7 months later, test after test, and had seen several physicians, no one can figure out what was going on. The reporter was patient's mother and was tracking back to see if this vaccination could be the cause, when she searched side effects of Menveo online, the patient's symptoms align with information listed.  The reporter stated that please help them to find a resolution to resolve her pain. The reporter denied to follow-up.
Sex: F
Vaccine: MNQ
Symptoms: Stress
Clinical narrative: tingling - issues in both legs; stress; anxiety; Leg weakness; Pain, shooting pain; numbness, Leg numbness; This non-serious case was reported by a consumer and described the occurrence of pain in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28-FEB-2023) for prophylaxis.   Additional patient notes included the patient was a completely healthy individual, no health issues, no injuries, no falls and active soccer player.   On 28-JUL-2022, the patient received Menveo 1 ml. On 31-JUL-2022, 3 days after receiving Menveo, the patient experienced pain (Verbatim: Pain, shooting pain), numbness (Verbatim: numbness, Leg numbness) and lower extremities weakness of (Verbatim: Leg weakness). On an unknown date, the patient experienced tingling (Verbatim: tingling - issues in both legs), stress (Verbatim: stress) and anxiety (Verbatim: anxiety). The outcome of the pain, numbness and lower extremities weakness of were not recovered/not resolved and the outcome of the tingling, stress and anxiety were not reported.   It was unknown if the reporter considered the pain, numbness, tingling, lower extremities weakness of, stress and anxiety to be related to Menveo.     It was unknown if the company considered the pain, numbness, tingling, lower extremities weakness of, stress and anxiety to be related to Menveo.   Additional Information: GSK receipt date: 23-Mar-2023 This report was submitted via the online direct entry reporting system. The patient received a dose of Shingrix and had leg numbness, pain, shooting pain, weakness and tingling issues in both legs.  The reporter reported that when they contacted the physician office on 8th January 2023 inquiring if symptoms could be a side effect from one of the vaccinations received, physician said it was not and most likely stress or anxiety etc.  7 months later, test after test, and had seen several physicians, no one can figure out what was going on. The reporter was patient's mother and was tracking back to see if this vaccination could be the cause, when she searched side effects of Menveo online, the patient's symptoms align with information listed.  The reporter stated that please help them to find a resolution to resolve her pain. The reporter denied to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago and 2nd not yet administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was received about year and half ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose a year ago and 2nd not yet administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-MAR-2023 The reporter was patient itself. The patient received first dose about a year and half ago but didn't get the second dose. The patient asked if he need to start with the first dose again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter asked who we could sue for the pain and who was the pharma company that supplied the shingles vaccination. The follow up would not possible as no contact details were available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Extra dose administered
Clinical narrative: Bone aiking, significant strong reaction; Received 3rd dose by error; This non-serious case was reported by a nurse via call center representative and described the occurrence of bone pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 29th August 2020) and Shingrix (received second dose on 23rd December 2020). Concomitant products included acetylsalicylic acid (Aspirin), bupropion hydrochloride (Wellbutrin) and nifedipine (Adalat).   On 15-MAR-2023, the patient received the 3rd dose of Shingrix. In MAR-2023, less than a week after receiving Shingrix, the patient experienced bone pain (Verbatim: Bone aiking, significant strong reaction). On 15-MAR-2023, the patient experienced extra dose administered (Verbatim: Received 3rd dose by error). In MAR-2023, the outcome of the bone pain was recovered/resolved. The outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the bone pain to be related to Shingrix.     It was unknown if the company considered the bone pain to be related to Shingrix.   Additional Information: GSK receipt date: 22-Mar-2023 The nurse reported that an immunocompetent patient that usually takes a few medications such as Prolistat, Vitamin D, Aspirin, Adalat, Wellbutrin and received by error a third dose of Shingrix and one day before the reporting day morning, the patient reported a significant strong reaction obviously, bone aching, but she was okay now.  No further details about this strong reaction was reported by the patient. The reporter consented to follow-up by email. The patient received third dose of Shingirx by error, which led to extra dose administered.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered an expired dose of Bexsero; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 24-year-old male patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.  On 21-MAR-2023, the patient received Bexsero. On 21-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Inadvertently administered an expired dose of Bexsero). The outcome of the expired vaccine used 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: 22-MAR-2023 Nurse stated that a medical assistant inadvertently administered an expired dose of Bexsero one day before reporting. The nurse stated that, the patient was assigned female at birth but was currently transitioning to male.  The reporter had consented to follow-up. At the time of reporting, the patient had received a dose of expired Bexsero vaccine, which had led to expired vaccine used.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given instead of Infanrix; 2 YO received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.  On 21-MAR-2023, the patient received Kinrix. On 21-MAR-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix given instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 2 YO received Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 22-MAR-2023 Nurse called to report with the intention of administering Infanrix for Dtap vaccine, mistakenly it was administered Kinrix. The reporter consented to follow-up via email. The 2 year old patient was given Kinrix instead of Infanrix, which had led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: A female patient received by error a Bexsero expired vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31-DEC-2022) for prophylaxis.  On 21-MAR-2023, the patient received Bexsero. On 21-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: A female patient received by error a Bexsero expired vaccine). The outcome of the expired vaccine used 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: 22-MAR-2023 The pharmacist had reported that a patient received by error a Bexsero expired vaccine. The reporter consented to follow-up via email. At the time of reporting, the patient received a dose of expired Bexsero vaccine, which had led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose around 2020, 2nd dose not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received in an unknown facility a dose of Shingrix around year 2020 ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose around 2020, 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Mar-2023 The pharmacist reported that the patient had not been administered second dose yet.  The patient asked could restart the vaccine series. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: FLU4, HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temprature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Havrix, Engerix B, Fluarix Quadrivalent 2022-2023 season and Boostrix. On an unknown date, an unknown time after receiving Havrix, Engerix B, Fluarix Quadrivalent 2022-2023 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administered after temprature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAR-2023 The physician assistant (PA) called in to add excursion details of the vaccine Havrix, Engerix, Fluarix, Boostrix. The PA reported they administered the vaccines that were exposed to inappropriate temperatures to many patients from 18th September 2022 up to a week ago on 9th March 2023, with Fahrenheit less than 10 minutes. The reporter enquired that should they get revaccinated. The PA unable to provide any vaccine or patient details. The reporter did not consent to follow-up. The patients were vaccinated with vaccine Havrix, Engerix, Fluarix, Boostrix after they were exposed to inappropriate temperatures, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Over 1 year since 1st dose, how to proceed with 2nd; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received over one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Over 1 year since 1st dose, how to proceed with 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Mar-2023 The reporter would like to know how to proceed with second dose if had been over 1 year since the first dose was given. The medical information did not speak with the provider, so please follow up with the sales representative for more information. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 12Dec2022, 2nd will be given on 22Mar2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (On 12th December 2022, received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 12Dec2022, 2nd will be given on 22Mar2023). The outcome of the incomplete course of vaccination 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:22-Mar-2023. No reactions was reported. It was reported that, the 2nd dose was not given prior to the reporting. The reporter did not consent to follow up. Till the time of reporting, patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 1 week later after 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17-FEB-2024) for prophylaxis.   Concomitant products included PEDIARIX.   On 01-NOV-2022, the patient received the 2nd dose of Pediarix. On 01-NOV-2022, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose 1 week later after 1st). The outcome of the drug dose administration interval too short 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:22-Mar-2023. Pharmacist reported that a 6 month old male patient received the 1st dose of Pediarix at his 2 month old visit on 26th Oct 2022 and accidentally got another dose 1 week later. No symptoms was reported. The reporter consented to follow up. Patient received 2nd dose of Pediarix earlier at 9 weeks than the recommended schedule, which led to  drug dose administration interval too short.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 39-year-old male patient who received HAV (Havrix 1440 adult) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 21-MAR-2023, the patient received Havrix 1440 adult. On 21-MAR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced expired vaccine used (Verbatim: Expired Havrix Administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was physician assistant. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. The patient received expired dose of Havrix adult, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Nov2021, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Nov2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 The pharmacist enquired that do he/she need to restart the series or administer the 2nd dose now. The reporter consented to follow up via postal. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Shingrix in product tab.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient of inappropriate age got Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   Concomitant products included PEDIARIX.   On 17-JAN-2023, the patient received Kinrix. On 17-JAN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient of inappropriate age got Kinrix). 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: 24-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter shared with 2nd line agent that a dose of Pediarix was administered. The reporter consented to follow-up. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to a 6-month-old; Adult dose given to a 6-month-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old female patient who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 07-SEP-2023) for prophylaxis.   On 24-MAR-2023, the patient received the 3rd dose of Engerix B adult. On 24-MAR-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Adult dose given to a 6-month-old) and adult product administered to child (Verbatim: Adult dose given to a 6-month-old). The outcome of the overdose and adult product administered to child 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: 21-MAR-2023 The nurse Leader/RN states that a patient was getting the 3rd dose of Engerix-B and the adult dose was administered instead of the pediatric dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. 6 month old patient was administered an adult dose of Engerix-B instead of the pediatric dose, which led to overdose and adult product administered to child.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose more than 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-Mar-2023 The patient disconnected from call before any further information could be obtained. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive second dose yet, which led to incomplete course of vaccination.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED PFIZER BIVALENT VACCINE AFTER BEING STORED AT ROOM TEMPERATURE OF 75 DEGREES FAHRENHEIT FOR 31 HOURS.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac failure congestive, Cardiogenic shock, Chronic respiratory failure, Diverticulum intestinal
Clinical narrative: Moderna vaccine was administered - reported by patient  HYPOTENSION 12/9/2021 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 ATHEROSCLEROSIS OF AORTA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 ATHEROSCLEROSIS OF AORTACARDIOGENIC SHOCK 12/9/2021 ATHEROSCLEROSIS OF AORTA HYPOTENSION 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE RESPIRATORY FAILURE 12/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HYPOTENSION 12/9/2021 DIVERTICULOSIS OF SIGMOID ACUTE RESPIRATORY FAILURE 12/17/2021 DIVERTICULOSIS OF SIGMOID ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 DIVERTICULOSIS OF SIGMOIDCHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 DIVERTICULOSIS OF SIGMOID CARDIOGENIC SHOCK 12/9/2021 DIVERTICULOSIS OF SIGMOID HYPOTENSION 12/9/2021 DYSPHONIA ACUTE RESPIRATORY FAILURE 12/17/2021 DYSPHONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 DYSPHONIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 DYSPHONIA CARDIOGENIC SHOCK 12/9/2021 DYSPHONIA HYPOTENSION 12/9/2021 PALLIATIVE CARE ACUTE RESPIRATORY FAILURE 12/17/2021 PALLIATIVE CARE ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 PALLIATIVE CARE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 PALLIATIVE CARE CARDIOGENIC SHOCK 12/9/2021 PALLIATIVE CARE
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Hypotension, Respiratory failure
Clinical narrative: Moderna vaccine was administered - reported by patient  HYPOTENSION 12/9/2021 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 ATHEROSCLEROSIS OF AORTA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 ATHEROSCLEROSIS OF AORTACARDIOGENIC SHOCK 12/9/2021 ATHEROSCLEROSIS OF AORTA HYPOTENSION 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE RESPIRATORY FAILURE 12/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HYPOTENSION 12/9/2021 DIVERTICULOSIS OF SIGMOID ACUTE RESPIRATORY FAILURE 12/17/2021 DIVERTICULOSIS OF SIGMOID ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 DIVERTICULOSIS OF SIGMOIDCHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 DIVERTICULOSIS OF SIGMOID CARDIOGENIC SHOCK 12/9/2021 DIVERTICULOSIS OF SIGMOID HYPOTENSION 12/9/2021 DYSPHONIA ACUTE RESPIRATORY FAILURE 12/17/2021 DYSPHONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 DYSPHONIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 DYSPHONIA CARDIOGENIC SHOCK 12/9/2021 DYSPHONIA HYPOTENSION 12/9/2021 PALLIATIVE CARE ACUTE RESPIRATORY FAILURE 12/17/2021 PALLIATIVE CARE ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 PALLIATIVE CARE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 PALLIATIVE CARE CARDIOGENIC SHOCK 12/9/2021 PALLIATIVE CARE
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: part of a dose leaked out of the syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 42YY3, expiry date 28-MAY-2024) for prophylaxis.   On 24-MAR-2023, the patient received the 1st dose of Shingrix. On 24-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: part of a dose leaked out of the syringe). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 A pharmacist called to inform that earlier that day part of a dose of Shingrix leaked out of the syringe while administering it to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Blood glucose increased, Blood test abnormal, Computerised tomogram head normal, Facial paralysis
Clinical narrative: I started having facial numbness and drooping on the left side of my face. I called my doctor, they could not see, when I described my symptoms, they instructed me to go immediately to the emergency room as they were the signs of a stroke. I had CT scan, bloodwork to check my blood glucose, blood pressure, oxygen. The doctors were able to eliminate that I did not have stroke, through other physical exams is was determined I had Bell's Palsy.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: I started having facial numbness and drooping on the left side of my face. I called my doctor, they could not see, when I described my symptoms, they instructed me to go immediately to the emergency room as they were the signs of a stroke. I had CT scan, bloodwork to check my blood glucose, blood pressure, oxygen. The doctors were able to eliminate that I did not have stroke, through other physical exams is was determined I had Bell's Palsy.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, COVID-19, Myalgia, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 10/03/2022. I started to experience extreme muscle and joint aches and pains on 02/19/2023. I tested COVID-19 Positive on 02/22/2023. I contacted my physician on 02/24/2023 and was stated because my case was mild.  I was not prescribed Paxlovid.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: On the night of 2/21/2023, I began getting a scratchy throat and cough. On 2/22/2023, I had what seemed like a cold. I took a home antigen test and got a positive result. On 2/22/2023, I had a fever of 101, which lasted one day. I began taking PAXLOVID on 2/24/2023 or 2/25/2023. The symptoms went away pretty quickly, and I tested negative after about seven days. At the time of this writing, I feel great and feel that I have made a full recovery.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, COVID-19, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: I had shortness of breath, sinus issues, and upper respiratory issues. I had a headache and my body was aching. I had complete exhaustion. For first 48 hours I was in bed sleeping and only got up to go to the restroom. I took TYLENOL. I was really out of it. About Sunday, I woke up and I was soaking wet like my fever broke and I started feeling better. The clinic prescribed me multiple anticoagulants and molnupiravir. I took medications for 5 days.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Hypersomnia, Mobility decreased, Pain
Clinical narrative: I had shortness of breath, sinus issues, and upper respiratory issues. I had a headache and my body was aching. I had complete exhaustion. For first 48 hours I was in bed sleeping and only got up to go to the restroom. I took TYLENOL. I was really out of it. About Sunday, I woke up and I was soaking wet like my fever broke and I started feeling better. The clinic prescribed me multiple anticoagulants and molnupiravir. I took medications for 5 days.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory disorder, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: I had shortness of breath, sinus issues, and upper respiratory issues. I had a headache and my body was aching. I had complete exhaustion. For first 48 hours I was in bed sleeping and only got up to go to the restroom. I took TYLENOL. I was really out of it. About Sunday, I woke up and I was soaking wet like my fever broke and I started feeling better. The clinic prescribed me multiple anticoagulants and molnupiravir. I took medications for 5 days.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient received his 1st Monovalent dose of Pfizer at 9:50am. A couple of minutes later during the observation period, patient said he was feeling anxious and a bit lightheaded. Patient was given another chair so he could put his legs up. Patient let RN know that he was going to pass out. Patient then fainted while sitting and was unconscious for a few second (about 15-30 seconds total) Patient was lowered onto floor carefully and regained consciousness. Patients BPM and BP was checked and he was monitored for about 30 minutes after. Patient then shared he was okay and left.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Chills, Headache, SARS-CoV-2 test positive
Clinical narrative: 11/07/2022 tested positive for COVID-19. I had chills and a headache. My symptoms were relatively mild so I did not seek medical care. Symptoms lasted 2-3 days. No medications.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received a 5-11 years bivalent booster 0.3mL instead of a 12+  bivalent booster. Patient was notified with error and correct dose was administered.