chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site haemorrhage, Nausea
Clinical narrative: Patient received Moderna Bivalent Booster 0.5 ml intramuscularly on R Deltoid. Patient looked over at site of injection, saw blood stain at injection site.  Patient reported feeling well at the moment. Guided to waiting room for 15 minutes for post vaccine wait. After approximately 10 minutes patient decided to get up and stand outside for a couple of minutes then returned inside stating he was feeling like he was "going to pass out".  MOA Madonna guided patient into exam room immediately and called for MA and provider.  Patient reported feeling anxious, clammy, nauseas, hot and sweaty.  Had patient lay back on exam table. Patient was provided with water to drink and wet wash cloth for forehead. Provider in office was notified and went into exam room to see patient. Pulse checked-between 60's and 70's BPM. Patient was offered crackers or juice. Patient declined.  Patient maintained in lying position with head elevated slightly for approximately 11 minutes. Patient reported feeling better and ready to leave. Patient left office
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient administered a dose of an expired vaccine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Mental impairment, Neurological symptom, Speech disorder
Clinical narrative: I started to develop a head fog the day after which also caused pressures to my head then developed to neurologic discretizes between speaking and thinking was becoming impaired. It wasn?t based off my coworkers, but I felt like I wasn?t talking correctly. The head fog and neurologic discretizes. So much so I ended up looking for pronunciations videos because I felt like I wasn?t speaking properly. The pressure was server like a 10 it felt like my head was in a vice and no over the counter medication did not help. My family doctor prescribed prednisone and said that she had heard of other side effects had been reported. I didn?t take the medication out of fear of further side effects. The symptoms took close to three weeks to resolve. At the 6 week point I started to feel like myself again.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Atrial fibrillation, COVID-19, Condition aggravated, Death
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 5 times with the Pfizer product, having received vaccine on 02/03/2021, 02/24/2021, 08/27/2021, 03/02/2022, and 08/17/2022. They were hospitalized 09/15/2022-09/23/2022for multiple reasons, including small bowel perforation, shock, hypoxic respiratory failure, multiple metastasized adenocarcinoma of the lung, acute renal failure, and a-Fib. They were transferred to a hospice facility on 09/23/2022. They tested negative for COVID-19 on 09/15/2022 and then positive on 09/25/2022 and 09/26/2022. Their health continued to decline and they died on 10/04/2022.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: General physical health deterioration, Intestinal perforation, Lung adenocarcinoma, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 5 times with the Pfizer product, having received vaccine on 02/03/2021, 02/24/2021, 08/27/2021, 03/02/2022, and 08/17/2022. They were hospitalized 09/15/2022-09/23/2022for multiple reasons, including small bowel perforation, shock, hypoxic respiratory failure, multiple metastasized adenocarcinoma of the lung, acute renal failure, and a-Fib. They were transferred to a hospice facility on 09/23/2022. They tested negative for COVID-19 on 09/15/2022 and then positive on 09/25/2022 and 09/26/2022. Their health continued to decline and they died on 10/04/2022.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Shock, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 5 times with the Pfizer product, having received vaccine on 02/03/2021, 02/24/2021, 08/27/2021, 03/02/2022, and 08/17/2022. They were hospitalized 09/15/2022-09/23/2022for multiple reasons, including small bowel perforation, shock, hypoxic respiratory failure, multiple metastasized adenocarcinoma of the lung, acute renal failure, and a-Fib. They were transferred to a hospice facility on 09/23/2022. They tested negative for COVID-19 on 09/15/2022 and then positive on 09/25/2022 and 09/26/2022. Their health continued to decline and they died on 10/04/2022.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Immunisation reaction, Urticaria
Clinical narrative: Hives on both arms, streaking  both top  and bottom, from top of hand to below shoulder on both arms. Described as 'covid arm'
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Eye movement disorder, Facial pain, Headache, Heterophoria
Clinical narrative: About a month after i got the first Covid vaccine jab 4/12/2021, I started having double vision when walking more than 20 minutes. The problem has gotten progressively worse at this point I have frequent headaches, double vision (over lapping images in field of vision), mostly after dark. soreness in the right side of my face. I often have to close my right eye to drive a car or watch TV..  I have had 5 jabs so far (I've continued to get covid boosters and vaccinations when available because my wife is a cancer survivor and I'm concerned for her health).  I've seen an optometrist twice an ophthalmologist and an Ear eye nose and throat specialist. They can't help me.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Visual field defect
Clinical narrative: About a month after i got the first Covid vaccine jab 4/12/2021, I started having double vision when walking more than 20 minutes. The problem has gotten progressively worse at this point I have frequent headaches, double vision (over lapping images in field of vision), mostly after dark. soreness in the right side of my face. I often have to close my right eye to drive a car or watch TV..  I have had 5 jabs so far (I've continued to get covid boosters and vaccinations when available because my wife is a cancer survivor and I'm concerned for her health).  I've seen an optometrist twice an ophthalmologist and an Ear eye nose and throat specialist. They can't help me.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: given 1st dose in Aug2022, no 2nd dose yet`; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (given 1st dose in Aug2022, no 2nd dose yet`) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    In August 2020, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (given 1st dose in Aug2022, no 2nd dose yet`) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (given 1st dose in Aug2022, no 2nd dose yet`) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       They had the 1st dose of the Moderna Covid-19 vaccine in Aug 2020 and never completed the 2nd dose. They have looked around in their area for a Moderna 2nd dose but no facility carries it anymore.  Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; GARDASIL 9 has been administered since the excursion occurred.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies, reactions or concomitant medications was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9 SYRINGE (DEVICE)) for prophylaxis (lot number 1780878 had been verified to be a valid number; expiration date 02-DEC-2023, and upon internal validation established as the same date) (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of -0.5 degrees Celsius (C), for a time frame of 168 hours, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.   This is a non-valid case due to the lack of patient identifiers.  Follow-up information has been received from a nurse on 01-DEC-2022.  The patient's demographics had been provided, a 20-years old male patient. His concurrent conditions included sinusitis and hypertension. The patient's pertinent medical history, drug allergies, reactions or concomitant medications was not provided.  On 24-OCT-2022, the patient was vaccinated with the third dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (conflicting information, also reported as quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine [GARDASIL]) injection, intramuscularly, on the right arm (dose, vaccination scheme and frequency were not provided) for prophylaxis (lot number 1780878 had been verified to be a valid number; expiration date 02-DEC-2023, and upon internal validation established as the same date). The reporter stated that the refrigerator for the vaccine went out of temperature range for too long and they did not realize until after the vaccine was given. The patient did not report any adverse effects. The rest of the vaccines had been properly dealt with.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient was administered a vaccine that was improperly stored; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 ml/once, lot number W024973, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). It was reported that before the administration the vaccine has been improperly stored (temperature: 18.3 Fahrenheit (F), time frame: 2 hours 16 minutes; previous temperature excursion: 11.7 F, 1 hour 48 minutes) (product storage error). No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2211USA001529: US-009507513-2211USA001622:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; a dose of VARIVAX that expired on 12AUG2022 was administered to a patient on 02NOV2022.; This spontaneous report was received from an office manager and referred to a patient of unspecified age or gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 02-NOV-2022, the patient received vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml), lot #T027303, expiration date: 12-AUG-2022, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). Patient did not experience any adverse events outside of the expired dose being administered. No additional AE information (no adverse event).
Age: 21.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details or PQC.; Inbound call from HCP stating a patient was inadvertently administered an expired dose of MMR-II.; the patient was 21 years old; This spontaneous report has been received from a registered nurse, referring to a 21 years old patient of unknown gender. The patient's historical condition and current condition were not reported. The patient's concomitant drug included sterile diluent (manufacturer unknown).  On 02-NOV-2022, the patient was inadvertently vaccinated with an expired dose (1 dosage form) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin (rHA)) (lot # S039311 with expiration date: 04-DEC-2021, dose, strength and route were not reported) for prophylaxis (expired product administered and product administered to patient of inappropriate age). No additional adverse event (AE) details or product quality complaints (PQC).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; dose of PNEUMOVAX 23 expired on 9/13/2022 and was administered on 11/3/2022; This spontaneous report has been received from a pharmacist concerning a patient of unreported age and gender. The patient's medical's history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 03-NOV-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # U002528, expiration date 13-SEP-2022 (route of administration and anatomical location were not provided) as prophylaxis (expired product administered). It was reported that no temperature excursions occurred previously. No additional events were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additioal AE's; A medical assistant reported that a dose of MMR II vaccine that was stored imptoperly pursuant tot temperature excursion was administered to a patient.  No additioal AE's and no PQC's were reported.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 22-NOV-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) subcutaneous injection, as prevention of measles, mumps and rubella infection (lot number U039910 has been verified to be valid; expiration date reported and established as 16-DEC-2023) (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided). No adverse event was reported.
Age: 17.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; MMR II and VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a Certified Medical Assistant concerning a 17-year-old male patient. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 10-NOV-2022, the patient was vaccinated with an improperly storage dose varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis, lot number U029496 with expiration date 21-SEP-2023 (dosage regimen and route of administration were not reported), and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number U013036 with expiration date 23-APR-2023 (dosage regimen and route of administration were not reported). The vaccines underwent a temperature excursion of -10 C up to 8 C (0.1 C) for 444 hours minutes and 0 seconds, with a previous temperature excursion of -10 C up to 8 C (-7.2 C) for 7 hours 54 minutes and 0 seconds (Product storage error). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Ill-defined disorder
Clinical narrative: shingles and other zoster-related conditions; shingles and other zoster-related conditions; death; Information has been received from a lawyer regarding a case in litigation and referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 29-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number, anatomical site of vaccination and route was not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles and other zoster-related conditions. It was also reported that the patient received medical attention and treatment for the events (unspecified). On 13-JUN-2020, the patient passed away. It was unknown whether an autopsy was performed. The cause of death was not reported.   At the reporting time, the outcome of the shingles and ill-defined disorder was not reported. The reporter considered the shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between the patient's death and zoster vaccine live (ZOSTAVAX) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse reporting VAQTA was administered after expiration. No additional AE. No PQC.; Nurse reporting VAQTA was administered after expiration. No additional AE. No PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 23-NOV-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # U031911, expiration date: 11-NOV-2022, 0.5 ml, strength and route of administration were unknown) for prophylaxis after expiration (expired product administered). No additional adverse event (AE) was reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE.; Caller stated a patient who received the complete series previously was administered a fourth dose.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On unknown dates, the patient was vaccinated with first, second and third doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported) for prophylaxis.  On 28-NOV-2022, the patient was vaccinated with a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, dose of 0.5 mL, lot number: U038662, expiration date: 10-AUG-2024 (route of administration and anatomical location were not reported) for prophylaxis (extra dose administered). No additional adverse event was reported (no adverse event).
Age: 14.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Hypoaesthesia, Incomplete course of vaccination, Laboratory test, Paraesthesia, Poor peripheral circulation
Clinical narrative: poor blood circulation in extremities; numbness; tingling; This spontaneous report was received from a consumer and refers to herself, a 15-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2012 (reported as 10 years ago), the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (reported as an unspecified HPV vaccine), intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2013 (reported as 1 year after vaccination), the patient experienced poor blood circulation in extremities, along with numbness and tingling. The patient had seen rheumatologist and had had several workups, even 4 days in hospital, to diagnose her symptoms. She had been referred to neurologist and psychologist at this time, as no diagnosis had been made. The patient found literature that suggested her symptoms could be related to HPV vaccine received. At the time of reporting, the patient had not recovered from any event.   The patient did not complete her hpv vaccine (unspecified) series due to the adverse reactions.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: irritation at the injection stie; pain at the injection stie; swelling at the injection stie; redness at the injection site; "ping pong ball" size lump on the left shoulder; This spontaneous report was received from a Health Professional via a company representative and refers to a 33-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-AUG-2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection  (lot #U037064 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as: 10-AUG-2024) administered as prophylaxis (strength, dose and route of administration were not provided). On 21-OCT-2022, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On an unknown date after the second dose of the vaccine, the patient  the patient had irritation, pain, swelling and redness at the injection site and eventually developed a "ping pong ball" size lump on the left shoulder.  The outcome of the events, the action taken with the therapy and the causality assessment were not provided.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The capsules were not refrigerated for 10 days; A spontaneous report was received from a patient on 06NOV2022. It described a male patient of unknown age who took "the capsules that were not refrigerated for 10 days" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) to vaccinate against typhoid. It was reported that the patient was prescribed four capsules of Vivotif recommended as one capsule every other day. Reportedly, the patient took the first dose of Vivotif on 01NOV2022, and following the second dose, he noticed that it was written on the box to refrigerate it. Furthermore, it was reported that he took the capsules that were not refrigerated for roughly 10 days and were kept at an average temperature of 55 degrees Fahrenheit and to most of 60 degrees, as the room was cold. Additionally, the lot number of the product was provided as 3003785 and 3003783. It was also reported that the capsules were kept in the refrigerator this last Friday (as per reporting) after he got to know about the refrigeration from the box. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  The medical/surgical history of the patient was reported as none and he stated that he also takes other medications (not specified).  No additional information was reported.  Company comment: It was reported that a consumer took the capsules that were not refrigerated for 10 days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the capsules that were not refrigerated for 10 days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Headache, Neck pain, Pain, Rash
Clinical narrative: Pt presented to the clinic today for concerns for a vaccine reaction that he received on 11/18/2022. Pt. Brought to an exam room to discuss concerns. Pt. States that he received a shingles vaccine on 11/18/2022 at the pharmacy and developed side effects of rash, chills, body aches but then later he developed headaches on and off and a sore neck and has concerns that he may be getting sick or getting COVID. Per system record no recent shingles vaccination was documented. Pt. Educated on the common side effects of the shingles vaccine and what an adverse reaction to a vaccination is. Pt. Informed that we are not able to test for COVID here and that he will need to go to his PCP, urgent care, or he can get a home COVID test. Pt. Verbalized understanding. Pt. Concerns where discussed with Nursing Supervisor. Supervising nurse stated that pt. Should follow up with entity that administered vaccine to report concerns and side effects and that patient can also file a VAERS report on behalf of himself. She also recommended that pt seek medical care and evaluation for symptoms experienced if they worsen or persist. This nurse returned to exam room to re-educate pt. Based on conversation with Nurse Supervisor. Before all education could be provided, pt. Injected that I dont know how shingles got into the conversation because I received a COVID vaccination. This nurse informed pt. That he told her that he got a shingles vaccination and that he received it at the Pharmacy. Pt. States that he got a COVID vaccination and that it was done her. Due to pt. Receiving a COVID vaccination, he was informed that we will file a VARES report but if he feels like he is getting sick he will need evaluation with PCP or at urgent care. Pt. Verbalized understanding. VARES report was filed. BSN, RN.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient said the night after receiving the flu shot...his right hand became painful in the middle of the night. The next day, he experienced numbness in  the right hand.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Arthralgia, Arthritis, Splint application, Tendonitis, X-ray limb abnormal
Clinical narrative: I started having gradual pain in the joint in my right thumb that became very severe. I couldn?t pick up a cup without it hurting. I went into the doctor, and they x-rayed the thumb and found arthritis that haven?t been there before. They also found tendonitis and prescribed prednisone. They recommend me to splint it, ice it, and warm compress. I still wear the splint, but it is a little better. I tried not to wear the splint one day and it got worse, so I keep it on.
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Last 2 doses administered were stored incorrectly; A spontaneous report was received from a patient on 07NOV2022. It described an elderly female patient (height: 66 inches) for whom the "last 2 doses administered were stored incorrectly" (PT: Product storage error) of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: 3003785) for immunisation. On 26OCT2022, the patient received the first dose of Vivotif. It was reported that the last 2 doses administered to the patient were stored incorrectly at a room temperature of 60 degrees Fahrenheit for about 36-48 hours. Reportedly, the patient did not face any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  The medical/surgical history and the concomitant medications of the patient was reported as none. The patient was allergic to Sulpha.  No additional information was reported.  Company comment: It was reported that the last 2 doses administered to the patient were stored incorrectly (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that the last 2 doses administered to the patient were stored incorrectly (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Crying, Irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Mom reports the patient developed fevers with T-max 103F the day after she received her 12-month immunizations (MMR, varicella, and hepatitis A immunizations) on 11?29.  She has had intermittent fevers daily but no fever noted today.  She has been extremely fussy.  She is consolable at times but has been crying on and off throughout the day and night.  Parents noticed a faint pink rash on her trunk, chest, and extremities today.   Parents deny any face/mouth swelling, difficulty breathing, vomiting, diarrhea, lethargy.   Prescribed Tylenol and Motrin alternating every 3 hours to be taken at home after 4ml of Motrin was given in clinic.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Pain in extremity
Clinical narrative: Sore arm, headache, developed COVID 2 days later
Age: 44.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, Cough, Dry throat, Malaise, Nasal congestion
Clinical narrative: My symptoms started on November 05, 2022. I had a dry scratchy throat for about three days. A few days later, I got a stuffy nose that progressively got worse. The stuffy nose lasted for about three days. Then, I developed a mild cough. I did an at home COVID-19 test on November 08, 2022, and it was positive. I went to the doctor for a COVID-19 PCR test the same day. That was also positive. I went into isolation. When I contacted my doctor, I asked for a prescription of Paxlovid. I started Paxlovid the evening of November 09, 2022. I finished the prescription on November 14, 2022. On the afternoon of November 17, I started having symptoms again. The stuffy nose came back. It progressively got worse, and I still had a mild cough. Late morning of the 18th, I took another COVID-19 home test, and it came back positive. On the 18th, I went back into isolation. On the night of the 18th, I started a second round of Paxlovid. I finished the Paxlovid on November 23rd, 2022. I left isolation on November 27, 2022. I still have a very mild cough, but that is my only lingering symptom.
Age: 44.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: My symptoms started on November 05, 2022. I had a dry scratchy throat for about three days. A few days later, I got a stuffy nose that progressively got worse. The stuffy nose lasted for about three days. Then, I developed a mild cough. I did an at home COVID-19 test on November 08, 2022, and it was positive. I went to the doctor for a COVID-19 PCR test the same day. That was also positive. I went into isolation. When I contacted my doctor, I asked for a prescription of Paxlovid. I started Paxlovid the evening of November 09, 2022. I finished the prescription on November 14, 2022. On the afternoon of November 17, I started having symptoms again. The stuffy nose came back. It progressively got worse, and I still had a mild cough. Late morning of the 18th, I took another COVID-19 home test, and it came back positive. On the 18th, I went back into isolation. On the night of the 18th, I started a second round of Paxlovid. I finished the Paxlovid on November 23rd, 2022. I left isolation on November 27, 2022. I still have a very mild cough, but that is my only lingering symptom.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received Bivalent Booster of Pfizer for the first shot in her primary series.  instead of the original Monovalent Vaccine.  Patient did not report any Adverse Reactions
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding second time after getting the Pfizer booster
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Ear pain, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Several hours after I got the COVID-19 vaccine I got a sore throat; next day started getting sinus headaches with congestion, next I  started feeling it in my chest; Still having what feels like a constant sinus infection with headache and ear aches; My Tinnitus has become a lot worse;  Got so severe that I contacted my Doctor and was prescribed an Albuterol Inhaler; Amoxicillin; Benzonatate; Codeine with Guaifenesin; Took a Home COVID-19 test, negative.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus headache, Tinnitus
Clinical narrative: Several hours after I got the COVID-19 vaccine I got a sore throat; next day started getting sinus headaches with congestion, next I  started feeling it in my chest; Still having what feels like a constant sinus infection with headache and ear aches; My Tinnitus has become a lot worse;  Got so severe that I contacted my Doctor and was prescribed an Albuterol Inhaler; Amoxicillin; Benzonatate; Codeine with Guaifenesin; Took a Home COVID-19 test, negative.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Loss of consciousness
Clinical narrative: patient passed out after receiving the flu shot and covid booster. we moved her to the floor and bent her knees, and she started to come to
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: I was fatigue, very congested, headache, shortness, and dizziness. I tested positive for COVID-19 at home. I spoke to my doctor, and he said that it would get better and give it time. He recommended that I take over the counters for congestion. In the last couple of weeks some of the dizziness came back.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I was fatigue, very congested, headache, shortness, and dizziness. I tested positive for COVID-19 at home. I spoke to my doctor, and he said that it would get better and give it time. He recommended that I take over the counters for congestion. In the last couple of weeks some of the dizziness came back.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a fever of 101.0 for about 2 days but that was it I never felt really bad I had been in an area with lots of people, so I took a self-test and COVID-19 Test came back positive. Then I went to the Clinic to get another test done to confirm me at home self-COVID-19 Test. This test was positive as well.  Then I contacted my doctor, and I was told since I was 71, she said to take the infusions over medication by mouth this was through a Televideo. I went and got the infusion on 9/30.  I never really felt bad I just got them injections because that's what my doctor said. I kept testing positive for the next few weeks and then week 3 I had a negative reading COVID-19 .My temperature also went back to normal.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Dyspnoea
Clinical narrative: PATIENT EXPERIENCE SHORTNESS OF BREATH. 911 WAS CALLED PATIENT WAS TAKEN BY AMBULANCE. SPOKE TO PATIENT FOLLOWING WEEK AND STATED SHE WAS GIVEN OXYGEN AND BENADRYL.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: No symptoms at this time, resident was test d/t exposure
Age: 63.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 1. patient requested flu shot when he checked in  at the pharmacy and confirmed that he came in to get flu shot before we administered it. However, patient's wife indicated that both of them already had the flu shot this year and wanted to get Pfizer today afterwards. 2. we accidently administered Fluad when patient is 63 years old.  3. patient does not have any signs or symptoms of the adverse effect by the time they left the pharmacy.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Wrong technique in product usage process
Clinical narrative: Took her first and second dose consecutively; Took her first dose of Vivotif with food; A spontaneous report was received from a nurse practitioner on 08NOV2022. It described a 51-year-old female patient who "took her first dose of Vivotif with food" (PT: Wrong technique in product usage process) and "her first and second dose consecutively" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: 3003687) for immunisation. It was reported that the patient took her first dose of Vivotif with food on 03NOV2022 followed by the second dose on 04NOV2022. Reportedly, the patient did not experience any side effects. The outcome of the reported events was not applicable.  Action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took her first dose of Vivotif with food (wrong technique in product usage process) and took her first and second dose consecutively (inappropriate schedule of product administration). Vivotif dose should be taken at least one hour before a meal and should be taken every other day, and the causality of wrong technique in product usage process and inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took her first dose of Vivotif with food (wrong technique in product usage process) and took her first and second dose consecutively (inappropriate schedule of product administration). Vivotif dose should be taken at least one hour before a meal and should be taken every other day, and the causality of wrong technique in product usage process and inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Cardiac failure, Computerised tomogram, Hypertransaminasaemia, Laboratory test
Clinical narrative: pulmonary embolism, acute heart failure with reduced ejection fraction, transaminitis, and pericarditis
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pericarditis, Pulmonary embolism, X-ray
Clinical narrative: pulmonary embolism, acute heart failure with reduced ejection fraction, transaminitis, and pericarditis
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Finished all 4 capsules of Vivotif and did not refrigerate it; A spontaneous report was received from a nurse on 09NOV2022. It described a female patient of unknown age who "finished all 4 capsules of Vivotif and did not refrigerate it" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient had completed the full course of vaccination with Vivotif and the capsules were never kept under refrigeration. Reportedly, the patient would be traveling on Friday (as per the reporting). The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer had taken four capsules of Vivotif and did not refrigerate it (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer had taken four capsules of Vivotif and did not refrigerate it (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Did not refrigerate the Vivotif capsules and administered all the incorrectly stored doses; A spontaneous report was received from a nurse on 09NOV2022. It described a 36-year-old female patient who "did not refrigerate the Vivotif capsules and administered all the incorrectly stored doses" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient did not refrigerate the Vivotif capsules and administered all the incorrectly stored doses as per the dosage regimen. Reportedly, the patient completed her regimen in the first week of NOV2022 and did not experience any side effects. Additionally, it was reported that the patient would be traveling on 11NOV2022. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer did not refrigerate the Vivotif capsules and administered all the incorrectly stored doses (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer did not refrigerate the Vivotif capsules and administered all the incorrectly stored doses (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Severe AE: Peripheral neuropathy grade 3; This case was reported by a consumer and described the occurrence of peripheral neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the peripheral neuropathy was unknown.   The reporter considered the peripheral neuropathy to be related to Shingrix.     Additional Information: GSK receipt date: 26-NOV-2022 Reporter's comment:  The patient stated that Shingrix vaccine caused severe adverse event as peripheral neuropathy grade 3. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccine didn't work, still got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-NOV-2022 Reporter's Comment: The patient self-reported this case via interactive digital media and described the occurrence of suspected vaccination failure. The patient stated that the vaccine didn't work for him/her. He/she still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: vaccine almost killed my dad; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter stated that this vaccine almost killed his dad The follow up would not possible, as no contact details were available.