chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Extreme increase in blood pressure, from an montly average of 125/89 rising up to a 195/130 in less than 12 hours.  I have not had high blood pressure in over the last 2 years after I changed my diet.  I reduced by using 2 year old lisinopril in a couple of days and then  a week later the same thing,  It happened 3 times in a month. After seeking medical help, I am now on 40 grams daily of lisinopril-hydrochlorothiazide to control it....   not cool....
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: After the vaccine was administered and paperwork was being completed, vaccinator realized that the vaccine expired on 3/4/23. The nurse at the healthcare facility and the patient were informed, and the dose will be re-administered per CDC recommendations. The patient has not experienced any adverse effects. The pharmacy was notified and staff was re-educated on auditing/removing expired medications.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Several weeks after the Covid vaccination I noticed a humming in my ears, which was mild at first but has become louder over time. This is devastating since I have good hearing and there is NO family history of this illness.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Magnetic resonance imaging, Tinnitus
Clinical narrative: Sometime around Feb/March 2022 I noticed buzzing in my head. I attributed it to pressure on upper molars from an improperly-fit dental device that I started wearing on 12/29/21 for sleep apnea and have been trying to find a remedy ever since. I had the device properly adjusted in Feb 2022 but despite the relief of pressure, and subsequent treatments the chronic buzzing hasn't stopped. I've now become aware that it may be a result of COVID vaccinations and I hope a remedy can be identified. This was my 3rd COVID vaccine - the previous were Pfizer Biontech ER8730 on 3//25/21, Pfizer Biontech EW0161 on 4/15/21 at local pharmacy. Subsequent vaccines were Moderna 059M21A on 5/7/22 and Moderna Bivalent AS71L10C on 10/12/22 at Pharmacy.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Borrelia test negative, Differential white blood cell count normal, Epstein-Barr virus test negative, Fatigue
Clinical narrative: Approximately 10 hours after receiving my second shot of Shingix on April 17, 2023 I began feeling the typical symptoms one often feels after a vaccination. Lethargy, weakness. I expected this because this is what I felt after receiving the first shot. However, after about 2 days these symptoms worsened. I felt completely fatigued to the point of exhaustion, also aches and pains, feverish, and pronounced Tinnitus.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count normal, Laboratory test normal, Lethargy, Mononucleosis heterophile test negative, Pain
Clinical narrative: Approximately 10 hours after receiving my second shot of Shingix on April 17, 2023 I began feeling the typical symptoms one often feels after a vaccination. Lethargy, weakness. I expected this because this is what I felt after receiving the first shot. However, after about 2 days these symptoms worsened. I felt completely fatigued to the point of exhaustion, also aches and pains, feverish, and pronounced Tinnitus.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Polymerase chain reaction negative, Pyrexia, Tinnitus
Clinical narrative: Approximately 10 hours after receiving my second shot of Shingix on April 17, 2023 I began feeling the typical symptoms one often feels after a vaccination. Lethargy, weakness. I expected this because this is what I felt after receiving the first shot. However, after about 2 days these symptoms worsened. I felt completely fatigued to the point of exhaustion, also aches and pains, feverish, and pronounced Tinnitus.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Discomfort, Flatulence, Gastrointestinal disorder
Clinical narrative: Roughly two weeks after 2nd dose I began suffering severe GI issues lasting several days at a time. These issues would come and go in cycles averaging 2-3 weeks in between bouts. Severe gut pain, lots of gas, bloating and diarrhea. This continued into the present day, however it has diminished quite a bit. At the current time I am experiencing cycles of uncomfortable bloating and gas, but not so much the diarrhea and wrenching gut pain. Nothing else changed in my diet or daily routine when this all started. The only new thing in my life was the vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal pain
Clinical narrative: Roughly two weeks after 2nd dose I began suffering severe GI issues lasting several days at a time. These issues would come and go in cycles averaging 2-3 weeks in between bouts. Severe gut pain, lots of gas, bloating and diarrhea. This continued into the present day, however it has diminished quite a bit. At the current time I am experiencing cycles of uncomfortable bloating and gas, but not so much the diarrhea and wrenching gut pain. Nothing else changed in my diet or daily routine when this all started. The only new thing in my life was the vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: RED WELT, PAIN AT INJECTION SITE
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: RED WELT, PAIN AT INJECTION SITE
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Loud tinnitus within 2 weeks of second shot
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling in the area around the site of administration after the vaccination which progressively got worse. She went and saw a provider at the urgent care on 04/29/2023 and was diagnosed with Cellulitis of the right upper arm. She was prescribed antibiotic Doxycycline by the provider for a 7 day course.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: severe flu like symptoms, body aches chills
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant persistent ringing in ears.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Deafness, Deafness unilateral, Ear discomfort, Eustachian tube disorder
Clinical narrative: First noticed tinnitus in 12/22, followed that month by sudden loss of hearing in right ear (robotic sounds, loss of hearing, unable to distinguish speech in a group, some balance issues that I noticed because I am a dancer).  1st doctor's visit 1/13/ 2023, tuning fork test showed loss of hearing on right side.  Referred to audiologist but could not get appointment till 3/6/2023.  Confirmed loss of lower tones in right ear.  Phone appointment with ENT specialist, Dr, who prescribed prednisone 60 mg. for 7 days (for inflammation) and ordered MRI to rule out tumor, etc.  Tests showed inner ear normal, no tumor, brain normal.  Recommended Flonaise for possible blockage of eustachian tube.  Steroids didn't help, sense of fullness has intensified, as has tinnitus and increasing hearing problems.  Can no long sing with a group because I can't hear my voice because of the tinnitus and compromised hearing.  Visit to my regular doctor 4/25/23 confirmed  problem likely being eustachian drainage.  My only options right now are continuing the Flonaise/Ipratroprium treatment and/or a steroid injection through the eardrum to reduce inflammation,  The onset of all of this was sudden and has quickly changed my lifestyle and activities.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inflammation, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Sudden hearing loss, Tinnitus
Clinical narrative: First noticed tinnitus in 12/22, followed that month by sudden loss of hearing in right ear (robotic sounds, loss of hearing, unable to distinguish speech in a group, some balance issues that I noticed because I am a dancer).  1st doctor's visit 1/13/ 2023, tuning fork test showed loss of hearing on right side.  Referred to audiologist but could not get appointment till 3/6/2023.  Confirmed loss of lower tones in right ear.  Phone appointment with ENT specialist, Dr, who prescribed prednisone 60 mg. for 7 days (for inflammation) and ordered MRI to rule out tumor, etc.  Tests showed inner ear normal, no tumor, brain normal.  Recommended Flonaise for possible blockage of eustachian tube.  Steroids didn't help, sense of fullness has intensified, as has tinnitus and increasing hearing problems.  Can no long sing with a group because I can't hear my voice because of the tinnitus and compromised hearing.  Visit to my regular doctor 4/25/23 confirmed  problem likely being eustachian drainage.  My only options right now are continuing the Flonaise/Ipratroprium treatment and/or a steroid injection through the eardrum to reduce inflammation,  The onset of all of this was sudden and has quickly changed my lifestyle and activities.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: vaccine was administered without issues; several minutes after administration, pt was sweating, flushed, light headed and said her chest felt heavy. pt remained seating and was instructed to rest, water was offered, pt took 50mg benadryl and still wasn't feeling good, 911 was called; pt did not lose consciousness, EMT evaluated pt (didn't notice any hives but pt may have been hyperventilating) and ended up transporting pt to hospital
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: PATIENT WAS ADMINISTERED 0.25 ML OF THE MODERNA BIVALENT 50 MCG/0.5 ML INSTEAD OF THE FULL 0.5 ML DOSE. THIS WAS DISCOVERED THE NEXT CLINIC DAY ON 4/21/23. PATIENT WAS ADMINISTERED A FULL 0.5 ML DOSE ON 4/24/23 PER CDC GUIDELINES FOR PATIENTS WHO WERE UNDERDOSED.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT 50 MCG/0.5 ML VACCINE ON 4/20/2023. PER CDC GUIDELINES FOR A PATIENT WHO WAS UNDERDOSED, THE PATIENT CAME BACK IN FOR A FULL DOSE (0.5 ML) OF THE MODERNA BIVALENT ON 04/24/2023
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Neck pain
Clinical narrative: The vaccines are listed as: DtaP, Tdap, and TD vaccines.  I have been experiencing pain in my neck on the side the shot was administered since the morning after receiving the injection. It's slowly getting better but still can't turn my head all the way to the left w/o significant pain.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Urticaria, Vomiting
Clinical narrative: 1-2 days after:  stomach ache, headache -- Tylenol 3 days after:  vomiting, diarrhea -- Pepto-Bismol 4-5 days after:  hives over 25% of body -- Decadron, Prednisone
Age: 68.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Injection site bruising
Clinical narrative: Patient reports bruising outside the injection site.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives traveling over entire body continuing until present day. 1 year 5 months so far.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Illness
Clinical narrative: I got Covid about a month after injection, then was sick multiple times after then with Covid being one the sicknesses again.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive for Covid 19
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus wringing in bilateral ears. Constant doesn?t stop
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Dizziness, Headache, Myalgia
Clinical narrative: headache, sore muscles, back pain, dizziness, low energy
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Exposure to noise, Insomnia, Tinnitus
Clinical narrative: A few days after receiving the Jansen Covid vaccine I noticed a significant increase and amplification of ringing in my ears.  I had some low grade tinnitus, probably from age and sound exposure, but it was barely noticeable and did not effect my daily health. I would say a scale of 3 out of 10.   Starting 3-4 days after the vaccine there was a dramatic increase in tinnitus volume and amplitude. Within two weeks the ringing was (and still is) almost unbearable.  This ringing  has not subsided to this day. I would rank it as a 9 out of 10.  It is affecting my health due to sleepless nights and the tinnitus intensity overwhelms my hearing most of the time.   After struggling with this for a year I made several appointments with hearing specialists.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Oral pain, Oropharyngeal discomfort, Urticaria
Clinical narrative: hive,black lump all over my body my throut lock up  and sore mouth
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Arthralgia, Gait inability, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Pelvic pain, Walking aid user
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Ageusia, Anosmia, Arthralgia, Balance disorder, Body temperature increased
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Bronchitis, Choking, Constipation, Diarrhoea, Disturbance in attention
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Dyspnoea, Fall, Fatigue, Gait disturbance, Injection site discolouration
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Memory impairment, Myalgia, Paraesthesia, Pneumonia, Productive cough
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Pyrexia, Respiratory disorder, Skin exfoliation, Streptococcus test negative, Tunnel vision
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Walking aid user, Wheezing
Clinical narrative: Post vaccine I had normal symptoms, loss of smell and taste, tired, a low-grade fever off and on that lasted 10 days. I wasn't miserable. I had pain in my injection site. I blew it off for probably 2 weeks. After the 2 weeks,  the red spot on my arm at the injection site was almost purple looking, hot to the touch and hard, like a rock. The fatigue got a lot worse, I saw my doctor in February 2023, I had a routine check-up and I brought up the symptoms to my doctor and he told me I should not get another COVID-19 vaccine. I find it still, some days and evening, I would be running a temperature the highest was 101. Sometimes the symptoms get worse after physical or emotional activity. There is always respiratory issues.  My doctor has treated me for respiratory issues, bronchitis, pneumonia. It is not sinus or allergy. There is a lot of wet cough. A lot of wheezing, and not being able to catch my breath. I cough so hard, I have hard time catching my breath, I take Rubitussin DM for the cough. When I lay flat, I absolutely choke. I can't catch my breath.  I have a hard time concentrating. I have a hard time sleeping. When I get up slow, I suffer from like tunnel vision. I have to wait for that before I can walk. I have pins and needles in my hands, I think it's because of a medication I take. My balance is terrible. I am tripping, and I have fallen. Sometimes I fall 10 times in a period of 2 weeks. I have to walk with a walker or a cane sometimes. My taste and smell comes and goes, still. The worst of it is the joint and muscle pain. The worse is the diarrhea, it is uncontrollable then I can go 3 or 4 days with constipation.  My skin is peeling off on my legs and on my forearms. It will peel off in big strips.  I have an appointment for next month to see a neurologist. My memory is not well. I can't recall a lot of information.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Eye movement disorder, Hypoacusis, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: Immediately after HPV was administered the patient said he started seeing white spots in his vision and he appeared to space out.  He also complained of dizziness and muffled hearing.  After lying down and drinking some water he started to feel better and symptoms resolved.  can get 2nd dose in 1 yr.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Visual impairment
Clinical narrative: Immediately after HPV was administered the patient said he started seeing white spots in his vision and he appeared to space out.  He also complained of dizziness and muffled hearing.  After lying down and drinking some water he started to feel better and symptoms resolved.  can get 2nd dose in 1 yr.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Feeling abnormal, Hypoacusis, Immediate post-injection reaction, Visual impairment
Clinical narrative: Immediately after HPV was administered the patient said he started seeing white spots in his vision and he appeared to space out.  He also complained of dizziness and muffled hearing.  After lying down and drinking some water he started to feel better and symptoms resolved.  can get 2nd dose in 1 yr.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood phosphorus, Blood sodium, Feeling hot, Weight
Clinical narrative: had covid 15Jul2022; had covid 15Jul2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9265) intramuscular, in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 2019 (ongoing); "COPD", start date: 2019 (ongoing), notes: COPD Saw something strange in lungs. Did not know what it was. She was told she done got something. They were thinking possible Covid strands, but did not know what it was. She was sent for a PET scan to look at heart and lungs. Scans came back, but something was covering right lung and can only use 2/3 of right lung; "Smoker", stop date: Feb2023, notes: Smoker Use to smoke at least half a pack to a pack a, day for the last 50 years. When she was placed in the, hospital she was trying to quit. She was unable to, totally quit. She was praying to get the taste away to, want to smoke. Concomitant medication(s) included: LORATADINE oral (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "unknown" and all described as "had covid 15Jul2022". The patient underwent the following laboratory tests and procedures: Weight: 180 pounds, notes: At the time she got the vaccine she was, 180 pounds at the time; 10-15 pounds, notes: 10-15 pounds since getting the vaccine.  Clinical course: She previously had covid 15Jul2022, four months earlier. Route Administered: Initially stated sub-q, but then stated the form looking at it does not say.  Product Quality Complaints Conclusion included: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lots EL9265, EN6201 and 30155BA were investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot, fill lot, and the formulated drug product lots. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specification.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event vaccination failure and COVID 19 cannot be ruled out.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure, Weight
Clinical narrative: had covid 15Jul2022; had covid 15Jul2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9265) intramuscular, in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 2019 (ongoing); "COPD", start date: 2019 (ongoing), notes: COPD Saw something strange in lungs. Did not know what it was. She was told she done got something. They were thinking possible Covid strands, but did not know what it was. She was sent for a PET scan to look at heart and lungs. Scans came back, but something was covering right lung and can only use 2/3 of right lung; "Smoker", stop date: Feb2023, notes: Smoker Use to smoke at least half a pack to a pack a, day for the last 50 years. When she was placed in the, hospital she was trying to quit. She was unable to, totally quit. She was praying to get the taste away to, want to smoke. Concomitant medication(s) included: LORATADINE oral (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "unknown" and all described as "had covid 15Jul2022". The patient underwent the following laboratory tests and procedures: Weight: 180 pounds, notes: At the time she got the vaccine she was, 180 pounds at the time; 10-15 pounds, notes: 10-15 pounds since getting the vaccine.  Clinical course: She previously had covid 15Jul2022, four months earlier. Route Administered: Initially stated sub-q, but then stated the form looking at it does not say.  Product Quality Complaints Conclusion included: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lots EL9265, EN6201 and 30155BA were investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot, fill lot, and the formulated drug product lots. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specification.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event vaccination failure and COVID 19 cannot be ruled out.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Medication error, No adverse event, Product storage error
Clinical narrative: At which point in the process the medication error occurred: Storage in clinical Practice; No additional adverse effects; Expired dose of VAQTA was administered to a patient / Give vaccine 6 days expired; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-OCT-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot number U024378 has been verified to be valid for hepatitis a vaccine, inactivated [VAQTA], expiration date reported and confirmed as 22-OCT-2022) (dose and route of administration not reported) as prophylaxis (Expired product administered). No adverse event was reported.  This is a non-valid case due to the lack of patient identifiers  Follow-up information has been received from the physician on 25-APR-2023.  The patient was a male of an unknown age.  He was vaccinated at his deltoid (it was not specified which side). The point in the process the medication error occurred was reported as: Storage in clinical Practice (Product storage error). No intervention was needed due to the event, the reporter only contact the Company line.  The reporter considered the event of Expired product administered (previously reported) as medically significant.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 27-year-old patient who received Hepatitis B vaccine (batch number NT9X3) for prophylaxis.   On 27-FEB-2023, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA713A) for prophylaxis.   On 13-JAN-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number BZ24H) for prophylaxis.   On 26-JAN-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient age is reported that less than a one year The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number BZ24H) for prophylaxis.   On 08-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient age is reported that less than a year. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: area is red and warm to touch; swelling on the injection site of the patients' arm that looked like a tick bite or a bullet; It also itched in the beginning but is now light pink; area is red and warm to touch; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 3 patients of an unknown demographics who experienced area is red and warm to touch, swelling on the injection site of the patients' arm that looked like a tick bite or a bullet, it also itched in the beginning but is now light pink after receiving vaccine yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine - Solution for injection strength, dose, expiry date; not reported lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious area is red and warm to touch (vaccination site warmth) (vaccination site erythema), swelling on the injection site of the patients' arm that looked like a tick bite or a bullet (vaccination site swelling), it also itched in the beginning but is now light pink (vaccination site pruritus) (unknown latency) following the administration of yellow fever vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events swelling on the injection site of the patients' arm that looked like a tick bite or a bullet, area is red and warm to touch, It also itched in the beginning but is now light pink.  At time of reporting, the outcome was Unknown for the event swelling on the injection site of the patients' arm that looked like a tick bite or a bullet, area is red and warm to touch, It also itched in the beginning but is now light pink.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cardiac stress test, Computerised tomogram, Cough, Dizziness
Clinical narrative: Tinnitus, fullness in ear, dizziness, lightheadedness, vertigo, imbalance started on 3/24. Urgent care visit (March 2021), ER visit( 4/1/21), ENT visit in April 2021 (initially diagnosed potential Meniere's). Fatigue and shortness of breath noticed. EKG and stress test done to rule out heart issues. After 2 months, the fullness in ear subsided. The lightheadedness, fatigue,  and dizziness continued (and still continues) upon any type of straining including sneezing, coughing, laughing, heavy lifting, etc. 2 MRI's and 2 CT Scans, most recent in April 2023 showed potential perilymph fistula.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear discomfort, Electrocardiogram, Fatigue, Magnetic resonance imaging abnormal
Clinical narrative: Tinnitus, fullness in ear, dizziness, lightheadedness, vertigo, imbalance started on 3/24. Urgent care visit (March 2021), ER visit( 4/1/21), ENT visit in April 2021 (initially diagnosed potential Meniere's). Fatigue and shortness of breath noticed. EKG and stress test done to rule out heart issues. After 2 months, the fullness in ear subsided. The lightheadedness, fatigue,  and dizziness continued (and still continues) upon any type of straining including sneezing, coughing, laughing, heavy lifting, etc. 2 MRI's and 2 CT Scans, most recent in April 2023 showed potential perilymph fistula.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Tinnitus, Vertigo
Clinical narrative: Tinnitus, fullness in ear, dizziness, lightheadedness, vertigo, imbalance started on 3/24. Urgent care visit (March 2021), ER visit( 4/1/21), ENT visit in April 2021 (initially diagnosed potential Meniere's). Fatigue and shortness of breath noticed. EKG and stress test done to rule out heart issues. After 2 months, the fullness in ear subsided. The lightheadedness, fatigue,  and dizziness continued (and still continues) upon any type of straining including sneezing, coughing, laughing, heavy lifting, etc. 2 MRI's and 2 CT Scans, most recent in April 2023 showed potential perilymph fistula.