chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 4/14/21 LOt# EW0158;  Pfizer 5/5/21 Lot# EW0179;  Pfizer 12/4/21 Lot# FJ8757;  Pfizer 5/2/22 Lot# FM9992
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: RN administered incorrect vaccine to patient; patient received flu vaccine instead of Tdap vaccine. He had previously received annual flu vaccine on 11/29/22. Patient is aware incorrect vaccine was administered. At this time, patient is not experiencing any adverse side effects.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Cough, Hypoacusis, Influenza, Influenza virus test negative
Clinical narrative: She got her vaccine and about an hour later she started coughing, sneezing.  She called the pharmacy and they said there was no information on the vaccine yet.  She then started using a box of tissues a day due to blowing her nose so much, running a high fever as her top lip blistered up and had a raw nose from all the blowing.  She had pains running down both sides of her neck to her shoulders.  This went on for about a week.  Her best kept trying to call her, she did not answer the phone.  She could not hear the phone ringing next to her as a friend was trying to get a hold of her.   Her friend called her son and he told her she had to go to the hospital  Her BP 85/42 and was given two prescription.  She was negative for COVID and the flu even though she had the symptoms of the flu.  She wasn't getting better so she called her PCP who called her in Amoxicillin which she has been on for a week.  She has to Friday to finish it.  She is almost 100% completely.  She forced herself to get up after she went home from the ER, and gradually started improving.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lip blister, Neck pain, Pyrexia, SARS-CoV-2 test negative, Skin erosion
Clinical narrative: She got her vaccine and about an hour later she started coughing, sneezing.  She called the pharmacy and they said there was no information on the vaccine yet.  She then started using a box of tissues a day due to blowing her nose so much, running a high fever as her top lip blistered up and had a raw nose from all the blowing.  She had pains running down both sides of her neck to her shoulders.  This went on for about a week.  Her best kept trying to call her, she did not answer the phone.  She could not hear the phone ringing next to her as a friend was trying to get a hold of her.   Her friend called her son and he told her she had to go to the hospital  Her BP 85/42 and was given two prescription.  She was negative for COVID and the flu even though she had the symptoms of the flu.  She wasn't getting better so she called her PCP who called her in Amoxicillin which she has been on for a week.  She has to Friday to finish it.  She is almost 100% completely.  She forced herself to get up after she went home from the ER, and gradually started improving.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sneezing
Clinical narrative: She got her vaccine and about an hour later she started coughing, sneezing.  She called the pharmacy and they said there was no information on the vaccine yet.  She then started using a box of tissues a day due to blowing her nose so much, running a high fever as her top lip blistered up and had a raw nose from all the blowing.  She had pains running down both sides of her neck to her shoulders.  This went on for about a week.  Her best kept trying to call her, she did not answer the phone.  She could not hear the phone ringing next to her as a friend was trying to get a hold of her.   Her friend called her son and he told her she had to go to the hospital  Her BP 85/42 and was given two prescription.  She was negative for COVID and the flu even though she had the symptoms of the flu.  She wasn't getting better so she called her PCP who called her in Amoxicillin which she has been on for a week.  She has to Friday to finish it.  She is almost 100% completely.  She forced herself to get up after she went home from the ER, and gradually started improving.
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Pfizer bivalent booster 5-11 yo given to adult
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose to early per CDC guidelines. Patient's 1st dose was 08/04/2022 and 2nd dose was 08/26/2022, this was 22 days apart.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Moderna 3/1/21 Lot# 043L20A;  Moderna 4/1/21 Lot# 038K20A;  Moderna 11/11/21 Lot# 024C21A
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Pt reports rash and redness that developed on his arm and shoulder area after injection.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 12/21/21 LOt# FJ8757;  Pfizer 6/13/22 Lot# FM0173
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 3/9/21 Lot# 023M20A;  MOderna 4/8/21 Lot# 018B21A;  Moderna 11/4/21 Lot# 039F21A;  Moderna 12/21/22 Lot# AS7170B
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was seen 10/7/22 and requested Pfizer Bivalent booster. Patient was actually given another dose of Pfizer Monovalent Booster. Patient was notified. Patient will return for correct vaccine.   No symptoms or side effects.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave patient wrong influenza immunization. No adverse reactions reported.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Influenza virus test negative, Lymphadenopathy, Malaise
Clinical narrative: I started feeling achy on the 24th. I had a low grade fever at around 99.1 and a sore throat. I had lymph node enlargement with a bad cough as well. I completed a home test which was negative. I completed a COVID 19 PCR test at the doctors office and it was positive. I was prescribed both PAXLOVID and azithromycin. It took about 4 days before I started feeling better at all. It took a long time for them to get better. I think I had a rebound case 1 week later. I was prescribed methylprednisolone and TESSALON PERLES for my symptoms. My symptoms improved in about 5 days. I still cough every day but it's not as bad.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test positive, Streptococcus test negative
Clinical narrative: I started feeling achy on the 24th. I had a low grade fever at around 99.1 and a sore throat. I had lymph node enlargement with a bad cough as well. I completed a home test which was negative. I completed a COVID 19 PCR test at the doctors office and it was positive. I was prescribed both PAXLOVID and azithromycin. It took about 4 days before I started feeling better at all. It took a long time for them to get better. I think I had a rebound case 1 week later. I was prescribed methylprednisolone and TESSALON PERLES for my symptoms. My symptoms improved in about 5 days. I still cough every day but it's not as bad.
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I received the Moderna Bivalent COVID-19 booster on 10/14/2022. On 10/26/2022, my daughter-in-law tested positive for COVID-19. I had recently spent time with her, so I decided to test myself. I took a home antigen test and got a positive result. I tested myself during the following days, and I didn't test negative until 10/30/2022. I never really had any symptoms, but I contacted my NP, who prescribed me PAXLOVID, which I started taking on 10/26/2022.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent was given as primary dose
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose too early per CDC Guidelines. Patient is aware and discussed with nurse. He will follow up to determine if he needs a second dose if severely immunocompromised.
Age: 46.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Condition aggravated, Fatigue, Headache, Pain
Clinical narrative: Extreme fatigue and body aches for 12 hours. I tested positive for COVID-19 on 12/18/2022. I had a headache for the first 2 days. I have phlegm in my throat and was fatigue for 3 days. My provider prescribed medication LAGEVRIO. I did a telehealth visit with my provider over the phone.
Age: 46.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Productive cough, SARS-CoV-2 test positive
Clinical narrative: Extreme fatigue and body aches for 12 hours. I tested positive for COVID-19 on 12/18/2022. I had a headache for the first 2 days. I have phlegm in my throat and was fatigue for 3 days. My provider prescribed medication LAGEVRIO. I did a telehealth visit with my provider over the phone.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose too early per CDC Guidelines. Patient is aware and discussed with nurse. Per patient he is not severely immunocompromised to receive another dose.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Bronchitis, Chills, Cough, Diarrhoea
Clinical narrative: I had chills, fever of 101 for a couple days, back pain, diarrhea, eye burning, sweats, headache, severe congestion, sneezing, and cough. I was sick for 6 days. I talked to my doctor, and she prescribed me over the counter drugs. I took MUCINEX, NYQUIL, and TYLENOL. She said I had bronchitis by my symptoms. I tested for COVID-19 and I was negative. I still have chest congestion.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye irritation, Headache, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: I had chills, fever of 101 for a couple days, back pain, diarrhea, eye burning, sweats, headache, severe congestion, sneezing, and cough. I was sick for 6 days. I talked to my doctor, and she prescribed me over the counter drugs. I took MUCINEX, NYQUIL, and TYLENOL. She said I had bronchitis by my symptoms. I tested for COVID-19 and I was negative. I still have chest congestion.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, Sneezing
Clinical narrative: I had chills, fever of 101 for a couple days, back pain, diarrhea, eye burning, sweats, headache, severe congestion, sneezing, and cough. I was sick for 6 days. I talked to my doctor, and she prescribed me over the counter drugs. I took MUCINEX, NYQUIL, and TYLENOL. She said I had bronchitis by my symptoms. I tested for COVID-19 and I was negative. I still have chest congestion.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: No reported symptoms. This vaccine was given erroneously as the first dose of the COVID-19 vaccination series instead of as third dose after completing two monovalent doses.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Bacterial test positive, Blister, Erythema, Facial pain, Herpes simplex test positive
Clinical narrative: My adverse event started on 01/10/2023 in the morning at 8:00AM. I had painful blisters on my nose. It was red and swollen. I called my doctor the next day on 01/11/2023  and scheduled an appointment. The nurse did a viral swab and a bacterial swab. I was positive with the viral swab for herpes. I was also positive for bacterial swab for Bacilli. The nurse prescribe me with an antiviral medication called valacyclovir for 4 days. I also went to a different doctor to discuss my results on 01/14/2023. He prescribe me with antibiotics clindamycin for 10 days and mupirocin ointment.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Herpes virus infection, SARS-CoV-2 test negative, Swelling face
Clinical narrative: My adverse event started on 01/10/2023 in the morning at 8:00AM. I had painful blisters on my nose. It was red and swollen. I called my doctor the next day on 01/11/2023  and scheduled an appointment. The nurse did a viral swab and a bacterial swab. I was positive with the viral swab for herpes. I was also positive for bacterial swab for Bacilli. The nurse prescribe me with an antiviral medication called valacyclovir for 4 days. I also went to a different doctor to discuss my results on 01/14/2023. He prescribe me with antibiotics clindamycin for 10 days and mupirocin ointment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Illness, Malaise, Oropharyngeal pain
Clinical narrative: I received a Pfizer COVID-19 booster on 6/6/2022. On 7/20/2022, I woke up feeling really tired. I also had a scratchy, sore throat. I decided to test myself, and the result was positive. I tested again 7/21/2022 and got another positive result. I didn't have too many symptoms during my illness. The main symptoms were fatigue and sore throat. I just took TYLENOL to treat my symptoms and waited out the virus.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I received a Pfizer COVID-19 booster on 6/6/2022. On 7/20/2022, I woke up feeling really tired. I also had a scratchy, sore throat. I decided to test myself, and the result was positive. I tested again 7/21/2022 and got another positive result. I didn't have too many symptoms during my illness. The main symptoms were fatigue and sore throat. I just took TYLENOL to treat my symptoms and waited out the virus.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Akinesia, Cardiac disorder, Cardiac failure acute, Chest discomfort, Computerised tomogram thorax abnormal
Clinical narrative: Patient is a 81 y.o. female who was admitted on 1/15/2023 for acute heart failure and elevated troponin.  The patient reported an episode of upper chest discomfort on around 3rd week of Dec.  It abated spontaneously.  She did not have any recurrent symptoms until about 3 days prior to presentation when she developed progressive dyspnea and was just unable to catch her breath.  She endorses orthopnea, PND and bend up knee.  Denied any recurrent chest discomfort.  No palpitations, presyncope or syncope
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea paroxysmal nocturnal, Echocardiogram abnormal, Ejection fraction decreased, Hypoperfusion
Clinical narrative: Patient is a 81 y.o. female who was admitted on 1/15/2023 for acute heart failure and elevated troponin.  The patient reported an episode of upper chest discomfort on around 3rd week of Dec.  It abated spontaneously.  She did not have any recurrent symptoms until about 3 days prior to presentation when she developed progressive dyspnea and was just unable to catch her breath.  She endorses orthopnea, PND and bend up knee.  Denied any recurrent chest discomfort.  No palpitations, presyncope or syncope
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemia, Left atrial enlargement, Magnetic resonance imaging heart, Mitral valve incompetence, Oedema
Clinical narrative: Patient is a 81 y.o. female who was admitted on 1/15/2023 for acute heart failure and elevated troponin.  The patient reported an episode of upper chest discomfort on around 3rd week of Dec.  It abated spontaneously.  She did not have any recurrent symptoms until about 3 days prior to presentation when she developed progressive dyspnea and was just unable to catch her breath.  She endorses orthopnea, PND and bend up knee.  Denied any recurrent chest discomfort.  No palpitations, presyncope or syncope
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Orthopnoea, Pleural effusion, Pulmonary mass, Scan with contrast, Tricuspid valve incompetence
Clinical narrative: Patient is a 81 y.o. female who was admitted on 1/15/2023 for acute heart failure and elevated troponin.  The patient reported an episode of upper chest discomfort on around 3rd week of Dec.  It abated spontaneously.  She did not have any recurrent symptoms until about 3 days prior to presentation when she developed progressive dyspnea and was just unable to catch her breath.  She endorses orthopnea, PND and bend up knee.  Denied any recurrent chest discomfort.  No palpitations, presyncope or syncope
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased, Ventricular hypokinesia
Clinical narrative: Patient is a 81 y.o. female who was admitted on 1/15/2023 for acute heart failure and elevated troponin.  The patient reported an episode of upper chest discomfort on around 3rd week of Dec.  It abated spontaneously.  She did not have any recurrent symptoms until about 3 days prior to presentation when she developed progressive dyspnea and was just unable to catch her breath.  She endorses orthopnea, PND and bend up knee.  Denied any recurrent chest discomfort.  No palpitations, presyncope or syncope
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Atrial tachycardia, Cardiac telemetry, Dyspnoea, Heart rate increased
Clinical narrative: When I had a massive pulmonary embolism, my heartrate went up extremely due to trouble breathing. The doctor stated I was having the issues due to not having enough air in my lungs. They diagnosed me with Atrial Tachycardia, and prescribed me with blood thinners to take for treatment.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: When I had a massive pulmonary embolism, my heartrate went up extremely due to trouble breathing. The doctor stated I was having the issues due to not having enough air in my lungs. They diagnosed me with Atrial Tachycardia, and prescribed me with blood thinners to take for treatment.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was given a pfizer bivalent vaccination that had been sitting out for longer than 12 hours.  No known adverse affect.  Vaccination just given incorrectly according to guidelines
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: After being exposed to COVID-19 took Home test and was positive; Tested positive for COVID-19 on 12/17/2022; Was prescribed Paxlovid; Tested negative for COVID-19 on 5th day, was feeling better; Then 10 days later rebounded and tested positive again for COVID-19 with a home test; Took another Home COVID-19 test 5 days later and tested negative.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a 3rd dose of Men ACY, W-135 instead of 2nd dose of Men B. No adverse reaction.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: It started feeling like a sinus problem under my eye. I started feeling really lousy really quickly with low grade fever. I felt like I was getting a cold or sinus infection. I took a home COVID-19 test and it was positive. I had taken some TYLENOL. During the night I began sneezing, fever 103 degrees, congestion, I wasn't hungry but drank a lot of water. The next morning I took another COVID-19 test and it was still positive. I was still taking some TYLENOL. The NP told me to take some mucous thinner over the counter medicine and she called me in some PAXLOVID which I took for 5 days. It took at least 2 days for me to start having any energy, and sinus congestion was getting better. I started sleeping during the night and kept taking MUCINEX before the congestion started to go away. I didn't have any rebound. This weekend I started feeling better now.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus congestion, Sinus disorder, Sneezing
Clinical narrative: It started feeling like a sinus problem under my eye. I started feeling really lousy really quickly with low grade fever. I felt like I was getting a cold or sinus infection. I took a home COVID-19 test and it was positive. I had taken some TYLENOL. During the night I began sneezing, fever 103 degrees, congestion, I wasn't hungry but drank a lot of water. The next morning I took another COVID-19 test and it was still positive. I was still taking some TYLENOL. The NP told me to take some mucous thinner over the counter medicine and she called me in some PAXLOVID which I took for 5 days. It took at least 2 days for me to start having any energy, and sinus congestion was getting better. I started sleeping during the night and kept taking MUCINEX before the congestion started to go away. I didn't have any rebound. This weekend I started feeling better now.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Electrocardiogram, Exposure to SARS-CoV-2
Clinical narrative: First, I don't believe that this is an adverse reaction to the vaccination, but I was asked to complete this form. I had Covid-19 in January, 2022. I had no immediate reaction after my 2nd booster on 5/9/22. We went on a cruise, and I tested negative for Covid at the beginning of the cruise and at the end of the cruise. I got a sinus infection on 6/14/22 after our return home, and I heard that a friend on the cruise who tested negative on the ship tested positive at home, so I went to clinic to be tested.  I tested negative for Covid but because of my history of Covid in January, they did a chest X-ray and EKG to rule out long Covid. The chest X-ray showed a large nodule in the left lower lobe of my lung.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Granuloma, Pathology test, Positron emission tomogram, Pulmonary mass
Clinical narrative: First, I don't believe that this is an adverse reaction to the vaccination, but I was asked to complete this form. I had Covid-19 in January, 2022. I had no immediate reaction after my 2nd booster on 5/9/22. We went on a cruise, and I tested negative for Covid at the beginning of the cruise and at the end of the cruise. I got a sinus infection on 6/14/22 after our return home, and I heard that a friend on the cruise who tested negative on the ship tested positive at home, so I went to clinic to be tested.  I tested negative for Covid but because of my history of Covid in January, they did a chest X-ray and EKG to rule out long Covid. The chest X-ray showed a large nodule in the left lower lobe of my lung.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Sinusitis, Surgery
Clinical narrative: First, I don't believe that this is an adverse reaction to the vaccination, but I was asked to complete this form. I had Covid-19 in January, 2022. I had no immediate reaction after my 2nd booster on 5/9/22. We went on a cruise, and I tested negative for Covid at the beginning of the cruise and at the end of the cruise. I got a sinus infection on 6/14/22 after our return home, and I heard that a friend on the cruise who tested negative on the ship tested positive at home, so I went to clinic to be tested.  I tested negative for Covid but because of my history of Covid in January, they did a chest X-ray and EKG to rule out long Covid. The chest X-ray showed a large nodule in the left lower lobe of my lung.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills
Clinical narrative: PT EXPERIENCED CHILLS AFTER ADMINISTRATION
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Aura, Condition aggravated, Feeling abnormal, Laboratory test
Clinical narrative: The next morning after the shot I was feeling "off". This feeling continued on and off for over a year without anything happening. Turns out that feeling was "auras" which are technically seizures. I proceeded to have a seizure at work and one in my sleep(both in 2022). I had a seizure back in 2018 from a fake weed cartridge, but got off the medicine within 9 months, so I was off it some time around March/April of 2019. Felt completely normal after getting off of it, and life was pretty much normal again. I get the vaccine in September of 2021, and the very next day I start feeling super "off". I assumed it was the anxiety of the whole pandemic situation and brushed it off for a while. My family and extended family aren't believers in the covid vaccine, and all my friends are super pro-vaccine. So I didn't want to tell my family I was feeling off and have them immediately jump to conclusions, and I didn't want to tell my friends and have them think I'm some sort of crazy conspiracy theorist/antivaxxer. So I stayed silent as this feeling persisted, and brushed it off as anxiety(at least I hoped). Well yea, now it turns out I'm having frequent seizures that weren't happening before the vaccine, that started happing pretty much right after I took it.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: The next morning after the shot I was feeling "off". This feeling continued on and off for over a year without anything happening. Turns out that feeling was "auras" which are technically seizures. I proceeded to have a seizure at work and one in my sleep(both in 2022). I had a seizure back in 2018 from a fake weed cartridge, but got off the medicine within 9 months, so I was off it some time around March/April of 2019. Felt completely normal after getting off of it, and life was pretty much normal again. I get the vaccine in September of 2021, and the very next day I start feeling super "off". I assumed it was the anxiety of the whole pandemic situation and brushed it off for a while. My family and extended family aren't believers in the covid vaccine, and all my friends are super pro-vaccine. So I didn't want to tell my family I was feeling off and have them immediately jump to conclusions, and I didn't want to tell my friends and have them think I'm some sort of crazy conspiracy theorist/antivaxxer. So I stayed silent as this feeling persisted, and brushed it off as anxiety(at least I hoped). Well yea, now it turns out I'm having frequent seizures that weren't happening before the vaccine, that started happing pretty much right after I took it.
Age: 52.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Asthenopia, Blood glucose normal, Diplopia, Feeling abnormal, Headache
Clinical narrative: C/O blurry vision and HA onset 3 hours after COVID-19 recombinant booster and flu IZ at SPLG 10/13; has to strain to see letters, they appear thick and wide on top and skinny on the bottom; eyes were feeling very strained, no red eye or pain w/EOMs but she couldn't drive starting AM after IZs due to strained vision. Mild HA secondary to eye strain. Blood sugar WNL <140. Endorsed she felt a bit weird too, not dizzy or lightheaded, no CP, palpitations, but her body and stomach 'felt weird.' Denies n/v. Appetite normal. No fever/chills/skin rash/body aches. Called PRIVATE 10/16 after hours then called back 10/17 spoke w/RN reports she told RN her sx and onset s/p IZs but per RN note in chart pt stated sx onset 10/12 - pt was convinced this was an eye problem and she made an appt 10/21 w/ophtho; RN recommended call same day for cancellation. Since then, sx have significantly improved and seem to be resolving. Has to strain a bit still but no vision loss, flashers/floaters, and letters/numbers look more normal. HA and 'weird' sensation also resolving. No new sx. She is amenable to FU with ophtho on 10/21 or ER if sx recurrent/worsening.  Pt reported Blurry vision and L side of Head pain. Pt reported vertical double vision at ER on 10/21
Age: 52.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Impaired driving ability, Vision blurred, Visual impairment
Clinical narrative: C/O blurry vision and HA onset 3 hours after COVID-19 recombinant booster and flu IZ at SPLG 10/13; has to strain to see letters, they appear thick and wide on top and skinny on the bottom; eyes were feeling very strained, no red eye or pain w/EOMs but she couldn't drive starting AM after IZs due to strained vision. Mild HA secondary to eye strain. Blood sugar WNL <140. Endorsed she felt a bit weird too, not dizzy or lightheaded, no CP, palpitations, but her body and stomach 'felt weird.' Denies n/v. Appetite normal. No fever/chills/skin rash/body aches. Called PRIVATE 10/16 after hours then called back 10/17 spoke w/RN reports she told RN her sx and onset s/p IZs but per RN note in chart pt stated sx onset 10/12 - pt was convinced this was an eye problem and she made an appt 10/21 w/ophtho; RN recommended call same day for cancellation. Since then, sx have significantly improved and seem to be resolving. Has to strain a bit still but no vision loss, flashers/floaters, and letters/numbers look more normal. HA and 'weird' sensation also resolving. No new sx. She is amenable to FU with ophtho on 10/21 or ER if sx recurrent/worsening.  Pt reported Blurry vision and L side of Head pain. Pt reported vertical double vision at ER on 10/21
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Echocardiogram, Fall
Clinical narrative: I experienced a TIA and/or a CVA on 1/6/2022 at approximately 2:30 p.m. and was taken by ambulance to Hospital where I was admitted overnight for observation and tests. On 1/10/2022 at approximately 4:00 a.m. I got up to void and fell into the shower area ; I was taken by ambulance to Hospital where I was diagnosed with a stroke and was airlifted to different Hospital where I was admitted  till Wednesday, January 12, 2022.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Implantable cardiac monitor insertion, Laboratory test, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: I experienced a TIA and/or a CVA on 1/6/2022 at approximately 2:30 p.m. and was taken by ambulance to Hospital where I was admitted overnight for observation and tests. On 1/10/2022 at approximately 4:00 a.m. I got up to void and fell into the shower area ; I was taken by ambulance to Hospital where I was diagnosed with a stroke and was airlifted to different Hospital where I was admitted  till Wednesday, January 12, 2022.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pfizer bivalent Booster 5-11 yo given to adult
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: PT GIVEN 2 DOSES OF PFIZER BIVALENT VACCINE
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chest pain, Echocardiogram normal, Hypoaesthesia, Neck pain
Clinical narrative: Left arm pain. Left chest pain. Left neck pain. Tingling in Left hand fingers. Sometimes a feeling of numbness.  Tingling in left arm. Tingling in Left chest. Tingling in Left neck. Tingling up back of Left side of head. No medical doctors have been able to give reasoning why. Visited emergency room in april 2021. Could not explain why these feeling were happening. Visited pain management doctor November 2021. They said it was a heart issue. Saw a cardiologist and did stress test and stress echo test in February of 2022. Test said heart was fine. Could not explain other symptoms. All symptoms are still occurring as of 1/17/2023.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain. Left chest pain. Left neck pain. Tingling in Left hand fingers. Sometimes a feeling of numbness.  Tingling in left arm. Tingling in Left chest. Tingling in Left neck. Tingling up back of Left side of head. No medical doctors have been able to give reasoning why. Visited emergency room in april 2021. Could not explain why these feeling were happening. Visited pain management doctor November 2021. They said it was a heart issue. Saw a cardiologist and did stress test and stress echo test in February of 2022. Test said heart was fine. Could not explain other symptoms. All symptoms are still occurring as of 1/17/2023.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was in clinic for an annual. Upon arrival, She was offered a flu shot. Patient stated that she don't remember getting the vaccine and would love to get it. After giving her the flu shot, upon charting it into System, System informed me that she had already received  the vaccine on 11-2022 and wasn't suppose to get another vaccine until 07-2023
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave PROQUAD to an adult patient; No additional AE reported; This spontaneous report was received from other health professional and refers to an adult patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 09-JAN-2023 Reporter comment: a pharmacist reported that a patient was given an expired dose of Bexsero on 9th January 2023. The Bexsero expired on 30th September 2022.  No symptoms reported. Did not consent to follow-up. The HCP declined to provide report details and declined consent for follow-up. HCP states she would report on her end. Additional Supportive Information: The patient received an expired dose of Bexsero vaccine which led to expired vaccine used.
Age: 60.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: received Bexsero instead of Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 60-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong 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: 09-JAN-2023 Reporter's Comments: The reporter stated that the patient received Bexsero on the day of reporting instead of Engerix B.  No additional details were provided. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Bexsero instead of Engerix B, which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose in 2020 and never came back for the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st August 2020 with batch number 7RK7K and expiry date 26th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-JAN-2023 Reporter's comment: The registered pharmacist (RPH) called to enquire how to proceed with Shingrix Series second dose (completing the series), should patient restart the series by getting two extra doses and if there was any harm with three doses. The patient never came back for the second dose.  The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got Both doses, 6 months later  shingles/ Suspected vaccination failure; Received both doses of Shingrix and developed Shingles approximately 6 months later; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior history of shingles once or twice).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and unknown after receiving Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comments: The reporter had stated that an individual patient who had received both doses of Shingrix and developed Shingles approximately 6 months later.  No other information known on the patient. The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 10-JAN-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: On the day of reporting, the patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiomyopathy, Dyspnoea, Echocardiogram abnormal, Incomplete course of vaccination
Clinical narrative: Cardiomyopathy; Shortness of breath (SOB) at night; This case was reported by a consumer via call center representative and described the occurrence of cardiomyopathy in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix. In September 2022, 2 months after receiving Shingrix, the patient experienced cardiomyopathy (serious criteria GSK medically significant). On an unknown date, the patient experienced shortness of breath. In January 2023, the outcome of the cardiomyopathy was recovered/resolved. On an unknown date, the outcome of the shortness of breath was unknown.   The reporter considered the cardiomyopathy and shortness of breath to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comments: The patient had stated that, he had received the first dose of Shingrix on 6 July 2022, in the left arm. He had not received second dose of Shingrix, on advisement of their cardiologist. The patient had reported of being diagnosed with cardiomyopathy approximately 2 months after receiving first Shingrix dose, in early September of 2022.  The patient had reported that the cardiologist was not able to confirm a link between the Shingrix vaccine and the cardiomyopathy, but was suspicious due to the timing and patient being very fit and healthy, with no previous cardiovascular concerns.  The patient had experienced Shortness of breath (SOB) at night, which had  led to seeking of treatment and being diagnosed with cardiomyopathy via echocardiogram. The patient had reported confirming resolution of cardiomyopathy via echocardiogram last week, after reduction of their physical activities/exercise for 3 months per advisement of cardiologist.  The reporter had consented to follow-up.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired Hiberix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-month-old female patient who received Hib (Hiberix) (batch number 42EM3, expiry date 7th January 2023) for prophylaxis.   On 10th January 2023, the patient received the 2nd dose of Hiberix. On 10th January 2023, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 10-JAN-2023 Reporter's comment: At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was administered an expired Hiberix dose, which led to expired vaccine used.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Syncope
Clinical narrative: episode of syncope; This case was reported by a nurse via call center representative and described the occurrence of syncopal attack in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023 11:30, the patient received Kinrix. On 10th January 2023, the patient started Kinrix Pre-Filled Syringe Device. On 10th January 2023, less than a day after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced syncopal attack (serious criteria GSK medically significant). On an unknown date, the outcome of the syncopal attack was unknown.   It was unknown if the reporter considered the syncopal attack to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: 10-JAN-2023 Reporter comment: The reporter reported that, after the administration of Kinrix vaccine the patient suffered from an episode of syncope. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 2nd January 2023) for prophylaxis.   On 9th January 2023, the patient received Engerix B. On 9th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The nurse reported that the patient received a dose of Engerix B which was already expired. No additional adverse event details available per healthcare professional.  The reporter consented to follow up. Additional Supportive Information: The use of Engerix B dose, which was already expired on 2nd January 2023, which led to expired vaccine used.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 7 year-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-JAN-2023 Reporter's comment:  The reporter reported that a 7 years old patient received a Kinrix dose. The reporter consented to follow up. Additional Supportive information: The patient received Kinrix dose at 7 years of age, which led to inappropriate age at vaccine administration.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired Hiberix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received Hib (Hiberix) (batch number 42EM3, expiry date 7th January 2023) for prophylaxis.   On 9th January 2023, the patient received the 3rd dose of Hiberix. On 9th January 2023, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 11-JAN-2023 Reporters comment: The reporter reported that patient received the third dose of hiberix vaccine on 09-JAN-2023 which was expired on 07-JAN-2023. The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up Additional Supportive information: The reporter reported that patient received the third dose of hiberix which was expired which led to expired vaccine used.