chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: accidently administered expired dose of Bexsero; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number abxc06aa, expiry date 31-MAR-2023) for prophylaxis.   On 11-MAY-2023, the patient received Bexsero. On 11-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: accidently administered 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: 11-MAY-2023 The reporter consented to follow up. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Kinrixwas given as a 3rd dose for Dtap and Polio (instead of 4th and 5th); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 04-MAY-2023, the patient received Kinrix. On 04-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrixwas given as a 3rd dose for Dtap and Polio (instead of 4th and 5th)). The outcome of the inappropriate schedule of vaccine administered 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: 11-MAY-2023 Licensed Practical Nurse (LPN) stated that, Kinrix was administered to the patient, but based on the patient's vaccine records, it was given as a 3rd dose for Dtap and Polio, instead of 4th and 5th.  The vaccine administration facility was the same as primary reporter. The Healthcare Professional (HCP) does not had the expiration date at time of call.  It was identified using the batch identifier. The reporter had consented to follow-up via postal. The patient was given Kinrix vaccine as a 3rd dose for Dtap and Polio, instead of 4th and 5th which had led to Inappropriate schedule of vaccine administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired dose of Kinrix  inadvertently administered one day after expiration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 08-MAY-2023, the patient received Kinrix. On 08-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired dose of Kinrix  inadvertently administered one day after expiration). 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: 11-MAY-2023 The reporter stated that an expired dose of Kinrix was inadvertently administered one day after expiration which led to expired vaccine used. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Protein urine present
Clinical narrative: Protein in urine; 3rd dose administered of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of protein urine present in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 3rd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered of shingrix). On an unknown date, the patient experienced protein urine present (Verbatim: Protein in urine). The outcome of the protein urine present and extra dose administered were unknown.   It was unknown if the reporter considered the protein urine present to be related to Shingrix.     It was unknown if the company considered the protein urine present to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The pharmacist called to inform that a patient believed that a 3rd dose of Shingrix had been administered to her back in March 2023 and mentioned that the patient was attributing presence in her urine to the third dose of Shingrix received. The reporter consented to follow up via mail. The patient received 3rd dose of Shingrix which led to Extra dose administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired dose of Kinrix was 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 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 11-MAY-2023, the patient received Kinrix. On 11-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired dose of Kinrix was administered). 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: 11-MAY-2023 The reporter stated that Kinrix was administered which was already expired on 7th May 2023, which led to expired vaccine used.  the vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up via mail.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient was administered a first dose of Boostrix in August 2022 and then today May-11-2023 a second dose was administered by mistake.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DH3A2, expiry date 29-SEP-2025) for prophylaxis.   Previously administered products included Boostrix (administered a first dose of Boostrix in 06 August  2022).   On 11-MAY-2023, the patient received Boostrix. On 11-MAY-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient was administered a first dose of Boostrix in August 2022 and then today May-11-2023 a second dose was administered by mistake.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date 11-MAY-2023 The medical assistant called to report that a patient received Boostrix and then again on the day of reporting was administered with another dose by mistake. The reporter did not consent to follow up. The patient received Boostrix and the second dose was administered, which led to extra dose administered.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose given; 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30-APR-2023) for prophylaxis.   On 04-MAY-2023, the patient received Menveo. On 04-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date 11-MAY-2023 The patient reported of receiving an expired dose of Menveo. The reporter wanted stability information and needed information for repetition of vaccine. The medical Safety staff member did not provide any additional details and medical information submitting all details as provided on web form. The reporter consented to follow up. Patient received a dose of Menveo on 4th May 2023 which was expired on  30th April 2023, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose almost 2 year ago but never completed the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose of Shingrix in September 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 almost 2 year ago but never completed the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-MAY-2023. Health care professional reported that a patient was vaccinated with Shingrix 1st dose almost 2 year ago but never completed the series which led to incomplete course of vaccination. Pharmacist reported that she had limited information. Lot and expiry date were unknown. Site of injection was unknown as well. The reporter requesting consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered a dose of Kinrix on 08May2023, which had an expiration date of 07May2023.; 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 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 08-MAY-2023, the patient received Kinrix. On 08-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Kinrix on 08May2023, which had an expiration date of 07May2023.). 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: 12-MAY-2023. GSK Representative reported a healthcare provided had emailed him requesting information on an expired dose of Kinrix that was administered to the patient.   Medical Information contacted the healthcare provider, who was the vaccine program coordinator.   The reporter stated that a patient was administered a dose of Kinrix on 08 May 2023, which had an expiration date of 07 May 2023 which led to expired vaccine used.   At the time of reporting, the dose had not been repeated. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose of Kinrix; 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 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 12-MAY-2023, the patient received Kinrix. On 12-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Administered an expired dose of Kinrix). 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: 12-MAY-2023 The reporter was unsure if this was the patient's fourth or fifth DTaP dose.   At the time of reporting, the dose has not been repeated. The patient was administered an expired dose of Kinrix which led to expired vaccine used. The vaccine administration Facility is the same as primary reporter. The reporter consented to follow up.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on dorsal side of both hands and lateral anticubital on both arms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, VARCEL
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: Mild skin rash, itching  on BIL legs in area of vaccines minutes after administration. No swelling. Medical assistant had used large sterile star shaped bandages. Bandages removed, iced packs placed, and patient reported improvement of her symptoms. Patient denied itching of the lips or throat, denied SOB, denied pain. No angioedema noted. Patient monitored 15 minutes and left with father who was instructed to go to ED if symptoms worsened. Suspect reaction is due to adhesive on the bandages.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nausea, Peripheral swelling
Clinical narrative: Fatigued the same day she received vaccine. The next day she, developed low grade fever, chills, nausea, headache, left arm swelling and tenderness. This has persisted for over 5 days. Arm swelling and tenderness are improving.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tenderness
Clinical narrative: Fatigued the same day she received vaccine. The next day she, developed low grade fever, chills, nausea, headache, left arm swelling and tenderness. This has persisted for over 5 days. Arm swelling and tenderness are improving.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Fatigue, Pain, Pyrexia
Clinical narrative: On May 7, 2023, I had endless sneezing, up to 50 or 60 times a day and a clear runny nose.  The next day I had a fever of 103 and terrible body aches.  I tested positive for COVID-19 May 8, 2023. I had a telehealth visit and was prescribed on this day.  After several days I started to feel better.  But the horrible taste of Paxlovid made me not hungry and I lost 10 pounds.  Sunday the 14th I tested negative.  As of today, I still feel exhausted and weak.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: On May 7, 2023, I had endless sneezing, up to 50 or 60 times a day and a clear runny nose.  The next day I had a fever of 103 and terrible body aches.  I tested positive for COVID-19 May 8, 2023. I had a telehealth visit and was prescribed on this day.  After several days I started to feel better.  But the horrible taste of Paxlovid made me not hungry and I lost 10 pounds.  Sunday the 14th I tested negative.  As of today, I still feel exhausted and weak.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots appeared on my left arm and then went away after a few weeks
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Severe tingling in left fingertips. Started briefly in right hand around 15:30, before fading in right hand and starting in left hand. Tingling continued for 2+ hours and started to fade around 18:00.
Age: 72.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Dizziness postural, Pain in extremity
Clinical narrative: Patient called today to report having soreness in her legs, arms and dizziness upon standing.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Blood thyroid stimulating hormone abnormal, COVID-19, Fatigue, Full blood count normal
Clinical narrative: On about 2/28/2023, I began to feel weak and feverish. I may have had a bit of a sore throat, but I'm not sure. I took a home antigen test on 3/2/2023, and the result was positive. After I tested positive, I isolated myself primarily in my bedroom. The symptoms were pretty mild, and I felt sort of like I had a bad cold, but I decided to stay in the bedroom as much as possible, as I did not want to expose my wife to the virus too much. I called my doctor and informed him of the situation, and he basically told me that I would have to wait it out. He asked me if I wanted Paxlovid, but I didn't feel sick enough to take it, so I didn't. About seven days after I tested positive, I tested myself again and got a negative response. After I made my recovery, I would often feel a little fatigued in the evenings. My temperature was also usually half a degree higher than my baseline. When I told my doctor about it, he wondered if I had long COVID-19. On 5/9/2023, I underwent a lipid panel, a urinalysis, a comprehensive metabolic panel, erythrocyte sedimentation rate, complete blood count, TSH, and C-reactive protein. They were all normal, except my TSH level was 5.92.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lipids normal, Metabolic function test normal, Oropharyngeal pain, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: On about 2/28/2023, I began to feel weak and feverish. I may have had a bit of a sore throat, but I'm not sure. I took a home antigen test on 3/2/2023, and the result was positive. After I tested positive, I isolated myself primarily in my bedroom. The symptoms were pretty mild, and I felt sort of like I had a bad cold, but I decided to stay in the bedroom as much as possible, as I did not want to expose my wife to the virus too much. I called my doctor and informed him of the situation, and he basically told me that I would have to wait it out. He asked me if I wanted Paxlovid, but I didn't feel sick enough to take it, so I didn't. About seven days after I tested positive, I tested myself again and got a negative response. After I made my recovery, I would often feel a little fatigued in the evenings. My temperature was also usually half a degree higher than my baseline. When I told my doctor about it, he wondered if I had long COVID-19. On 5/9/2023, I underwent a lipid panel, a urinalysis, a comprehensive metabolic panel, erythrocyte sedimentation rate, complete blood count, TSH, and C-reactive protein. They were all normal, except my TSH level was 5.92.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Urine analysis normal
Clinical narrative: On about 2/28/2023, I began to feel weak and feverish. I may have had a bit of a sore throat, but I'm not sure. I took a home antigen test on 3/2/2023, and the result was positive. After I tested positive, I isolated myself primarily in my bedroom. The symptoms were pretty mild, and I felt sort of like I had a bad cold, but I decided to stay in the bedroom as much as possible, as I did not want to expose my wife to the virus too much. I called my doctor and informed him of the situation, and he basically told me that I would have to wait it out. He asked me if I wanted Paxlovid, but I didn't feel sick enough to take it, so I didn't. About seven days after I tested positive, I tested myself again and got a negative response. After I made my recovery, I would often feel a little fatigued in the evenings. My temperature was also usually half a degree higher than my baseline. When I told my doctor about it, he wondered if I had long COVID-19. On 5/9/2023, I underwent a lipid panel, a urinalysis, a comprehensive metabolic panel, erythrocyte sedimentation rate, complete blood count, TSH, and C-reactive protein. They were all normal, except my TSH level was 5.92.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site vesicles, Scab, Varicella
Clinical narrative: Red chickenpox blisters at injection site (oldest blisters which iis now crusting) that started 15 days after injection, back of neck(older blister hasn't crusted yet), above left buttocks(older blister that hasn't crusted yet), and around mouth(smaller and just starting).
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Patient presented to office with rash; diagnosed as Erythema Multiforme.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Amnesia, Dizziness, Seizure, Syncope
Clinical narrative: pt rec'd vaccine, sat in waiting area for 5 minutes, reported feeling lightheaded, then collapsed onto floor, appeared to be having a small seizure for less then 60 seconds, then immediately sat up on the floor and asked rph what happened, he did not remember; 911 was called and pt was taken away in ambulance
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date and patient had no reported adverse event outcome
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Brain fog, Cardiac electrophysiologic study, Chest pain, Dizziness
Clinical narrative: Jan 10th 2022 - Nausea, Vomiting, Heart was racing, sitting down my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.  I did not seek medical care for this event. April 8th 2022 - Nausea, Vomiting, Heart was racing, mild chest pain and shortness of breath,  my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.   The friend i was with called 911 and i was transported via ambulance to a local hospital with labs and ekg, no significant findings, potential bladder infection was prescribed antibiotics From June 2022 through September 2022  - i Continued to have multiple episodes weekly (anywhere from 1 to 7 episodes a week), episodes typically included multiple of the following symptoms: Nausea, Vomiting, Dizziness, Shortness of Breath, Chest Pain, fatigue, brain fog, air hunger like i could not get enough oxygen in, feeling of impending doom like i was going to die, and my heart racing, at one point my heart rate got up to 186 as i was laying down trying to go to sleep.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Fatigue
Clinical narrative: Jan 10th 2022 - Nausea, Vomiting, Heart was racing, sitting down my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.  I did not seek medical care for this event. April 8th 2022 - Nausea, Vomiting, Heart was racing, mild chest pain and shortness of breath,  my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.   The friend i was with called 911 and i was transported via ambulance to a local hospital with labs and ekg, no significant findings, potential bladder infection was prescribed antibiotics From June 2022 through September 2022  - i Continued to have multiple episodes weekly (anywhere from 1 to 7 episodes a week), episodes typically included multiple of the following symptoms: Nausea, Vomiting, Dizziness, Shortness of Breath, Chest Pain, fatigue, brain fog, air hunger like i could not get enough oxygen in, feeling of impending doom like i was going to die, and my heart racing, at one point my heart rate got up to 186 as i was laying down trying to go to sleep.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Laboratory test, Nausea, Palpitations, Stress echocardiogram
Clinical narrative: Jan 10th 2022 - Nausea, Vomiting, Heart was racing, sitting down my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.  I did not seek medical care for this event. April 8th 2022 - Nausea, Vomiting, Heart was racing, mild chest pain and shortness of breath,  my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.   The friend i was with called 911 and i was transported via ambulance to a local hospital with labs and ekg, no significant findings, potential bladder infection was prescribed antibiotics From June 2022 through September 2022  - i Continued to have multiple episodes weekly (anywhere from 1 to 7 episodes a week), episodes typically included multiple of the following symptoms: Nausea, Vomiting, Dizziness, Shortness of Breath, Chest Pain, fatigue, brain fog, air hunger like i could not get enough oxygen in, feeling of impending doom like i was going to die, and my heart racing, at one point my heart rate got up to 186 as i was laying down trying to go to sleep.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Jan 10th 2022 - Nausea, Vomiting, Heart was racing, sitting down my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.  I did not seek medical care for this event. April 8th 2022 - Nausea, Vomiting, Heart was racing, mild chest pain and shortness of breath,  my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.   The friend i was with called 911 and i was transported via ambulance to a local hospital with labs and ekg, no significant findings, potential bladder infection was prescribed antibiotics From June 2022 through September 2022  - i Continued to have multiple episodes weekly (anywhere from 1 to 7 episodes a week), episodes typically included multiple of the following symptoms: Nausea, Vomiting, Dizziness, Shortness of Breath, Chest Pain, fatigue, brain fog, air hunger like i could not get enough oxygen in, feeling of impending doom like i was going to die, and my heart racing, at one point my heart rate got up to 186 as i was laying down trying to go to sleep.
Age: 0.75
Sex: M
Vaccine: COVID19-2, HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event Child was given booster dose (0.2 ml) instead of primary dose (0.25 ml) - child was underdosed. Second primary dose (0.25 ml) to be given 8 weeks after 4/27/23 dose. No booster will be given
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event Patient was given booster dose (0.2 ml) instead of the primary dose of 0.25 ml. Child was underdosed. Child will receive a bivalent primary dose (0.25 ml) 8 weeks after the 4/27 dose. No further booster.
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Electroencephalogram normal, Facial paralysis, Muscle twitching
Clinical narrative: With one day baby developed a drooping eye & twitching of leg. The eye drooping lasted a week & the leg twitching was intermittent for 6 weeks
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient scheduled an appointment for a shingles vaccine. He came in for a shingles vaccine. The MA administered the shingles vaccine and then noticed when documenting that the patient had already had the 2 dose series. He really needed a Hepatitis B vaccine. Doctor, Patient and Manager notified. No apparent issues when 3rd dose was received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose.  The pediatric vaccine was also not diluted prior to administration.  In addition 0.25mL was given instead of 0.3mL.  The patient had no adverse reaction or symptoms due to the dosing error.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dependence on respirator, Dialysis, Dyspnoea, Granulomatosis with polyangiitis
Clinical narrative: Patient had a prolonged hospitalization beginning after his second COVID vaccination. Patient admitted 6/4/2021 after experiencing SOB and eventually vent-dependent respiratory failure, renal failure requiring dialysis, with concern for Wegener?s vasculitis. Discharge diagnosis: Wegener's granulomatosis. Patient chart notes anaphylaxis as a reaction to Covid-19 Mrna Vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Renal failure, Respiratory failure
Clinical narrative: Patient had a prolonged hospitalization beginning after his second COVID vaccination. Patient admitted 6/4/2021 after experiencing SOB and eventually vent-dependent respiratory failure, renal failure requiring dialysis, with concern for Wegener?s vasculitis. Discharge diagnosis: Wegener's granulomatosis. Patient chart notes anaphylaxis as a reaction to Covid-19 Mrna Vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Peripheral swelling, Tenderness
Clinical narrative: After receiving the vaccine, my left arm began to swell, very sore to the touch and it progressed throughout the day. It lasted a good while. I did not go to the doctor. I did not take anything to help with the discomfort.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report was received from a medical assistant referring to a 12 months old female patient (also reported as 14 months old). No information on patients' pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 20-JAN-2023, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # W006412, expiration date: 23-FEB-2024, strength, dose and route were unknown) for prophylaxis. The vaccine underwent a temperature excursion (product storage error). Temperature excursion occurred as result of reading from digital data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperture excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 03-MAY-2023, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot#: W031815, expiration date: 05-OCT-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered experienced temperature excursion of 9F for 2 hours and 6 minutes (product storage error). No additional adverse events (AE) were reported (no adverse event).  This case was received from the same reporter with the case 2305USA001754.; Sender's Comments:  US-009507513-2305USA001754:
Sex: U
Vaccine: HEPA, PNC15
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP called to report the patient was given a dose of VAQTA  and VAXNEUVANCE after the doses were stored improperly. case with the supported outcome. No additional AE/PQC      ?    Names of vaccines involved (including lot/exp) VAQTA; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with improperly storage hepatitis a vaccine, inactivated (VAQTA) 0.5ml/ series, valid lot #X003791, expiration date: 01-JUN-2024 (frequency, strength, and route of administration were not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5ml/ series, valid lot #W027275, expiration date: 09-JUL-2024 (frequency, strength, and route of administration were not provided). Both administered for prophylaxis. It was reported a temperature excursion occurred (on 02-MAY-2023) with temperature reported as 34 Fahrenheit (F) for 7 hours. At the reporting time, the outcome of the event was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE reported.; a patient was inadvertently administered PROQUAD and VARIVAX.; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On 10-MAY-2023 (reported as "today"), the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, lot #W016360 (expiration date not reported but upon internal validation established as 16-NOV-2023), administered as prophylaxis (strength, anatomical location, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #W011624, (expiration date not reported but upon internal validation established as 06-APR-2024), administered as prophylaxis (strength, anatomical location, and route of administration were not provided) (Accidental overdose). No adverse events were reported.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event on patient; Temperature excursion total time: 25 mins, 3 excursions on dates: 09-SEP-2022 for 8 minutes; 10-SEP-2022 for 5 minutes; 03-JAN-2023 for 12 mins; This spontaneous report was received from an office manager, referring to a 11-year-old female patient.   The patient's concurrent conditions, concomitant therapies and medical history was not provided.  Since 09-SEP-2022, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe doses experienced 3 temperature excursions as follows: on the same date for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 mins (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day.   On 08-MAR-2023, the patient was vaccinated at private's doctor's office/hospital with a dose of the aforementioned doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (administration sites, and routes of administration were not provided) and was administered by the ordering physician for prophylaxis. Involved lot numbers and expiration dates were: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023. This report was called because of a data logger. There were no issues, nor adverse event reported on patient.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: TEMPERATURE EXCURSION IN REFRIGERATOR UNIT FOR 18 MONTHS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced temperature excursion in refrigerator unit for 18 months, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and temperature excursion in refrigerator unit for 18 months was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Side effects after each dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects after each dose) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects after each dose). At the time of the report, IMMUNISATION REACTION (Side effects after each dose) outcome was unknown.            Concomitant medication information was not reported.  The patient had also received first, second, third and fourth doses of Moderna COVID-19 vaccine.  Treatment information was not reported.   This case was linked to MOD-2023-723955 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effects after each dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects after each dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects after each dose). At the time of the report, IMMUNISATION REACTION (Side effects after each dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.   This case was linked to MOD-2023-723945 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: DVT; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria death and medically significant). The reported cause of death was dvt. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not reported. Company comment: This fatal spontaneous case concerns adult female patient in her twenties, with no medical history, who experienced the fatal and unexpected AESI of DEEP VEIN THROMBOSIS (death and medically significant) after an unspecified dose of mRNA-1273.222 vaccine. No details of previous doses were provided. The reported cause of death was deep vein thrombosis. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Reported Cause(s) of Death: DVT
Sex: F
Vaccine: COVID19-2
Symptoms: Thyroid disorder
Clinical narrative: severe thyroid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THYROID DISORDER (severe thyroid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THYROID DISORDER (severe thyroid). At the time of the report, THYROID DISORDER (severe thyroid) outcome was unknown.            No concomitant medication information was provided.  It was reported that after receiving the fifth inoculation, the patient had sever thyroid for which the patient was under treatment.   This case was linked to US-MODERNATX, INC.-MOD-2023-696717 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696717:Husband case
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced COVID-19 (Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease). At the time of the report, COVID-19 (Received 3rd booster on OCT-2022 and 6 months after the 3rd booster she had COVID Disease) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as additional booster. No treatment information was provided.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023; No adverse event; Administered within 5 days of the expiration of the beyond-use-date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered within 5 days of the expiration of the beyond-use-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered within 5 days of the expiration of the beyond-use-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 03-May-2023).    No concomitant medications were provided. It was administered within 5 days of the expiration of the beyond-use-date, which was 29-Apr-2023. The vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 30-Mar-2023.  No treatment medication was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other  vaccines in the 4 weeks prior to COVID-19 vaccine and was also unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     On 29-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-724032 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724032:same reporter