chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperacusis, Tinnitus
Clinical narrative: continuous high pitched whistling buzz for more than a year, no treatment, and continues
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: death
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Musculoskeletal stiffness
Clinical narrative: patient said the vaccine made him feel worse than having covid itself (he had it last year). he became so weak that he had to go to the ER. he said he felt like his whole body was seizing up. they did a bunch of tests on him and ended up sending him home and he is feeling better now and back to normal
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Erythema
Clinical narrative: flushed face, faint feeling, swelling of lips, tongue and throat, itchy red skin, difficulty breathing and swallowing, dizziness, light-headedness, needed and epinephrine injection, ambulance, taken to emergency room stayed under observation for several hours. Benadryl for several days after, had relapse of same conditions after two days. After a couple of months, condition on leg developed known as Erythema nodosum, a type of panniculitis which is caused by an allergic reaction to medication; this condition continues to worsen
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema nodosum, Flushing, General physical health deterioration, Hypersensitivity, Immunisation reaction
Clinical narrative: flushed face, faint feeling, swelling of lips, tongue and throat, itchy red skin, difficulty breathing and swallowing, dizziness, light-headedness, needed and epinephrine injection, ambulance, taken to emergency room stayed under observation for several hours. Benadryl for several days after, had relapse of same conditions after two days. After a couple of months, condition on leg developed known as Erythema nodosum, a type of panniculitis which is caused by an allergic reaction to medication; this condition continues to worsen
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Panniculitis, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: flushed face, faint feeling, swelling of lips, tongue and throat, itchy red skin, difficulty breathing and swallowing, dizziness, light-headedness, needed and epinephrine injection, ambulance, taken to emergency room stayed under observation for several hours. Benadryl for several days after, had relapse of same conditions after two days. After a couple of months, condition on leg developed known as Erythema nodosum, a type of panniculitis which is caused by an allergic reaction to medication; this condition continues to worsen
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: flushed face, faint feeling, swelling of lips, tongue and throat, itchy red skin, difficulty breathing and swallowing, dizziness, light-headedness, needed and epinephrine injection, ambulance, taken to emergency room stayed under observation for several hours. Benadryl for several days after, had relapse of same conditions after two days. After a couple of months, condition on leg developed known as Erythema nodosum, a type of panniculitis which is caused by an allergic reaction to medication; this condition continues to worsen
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Fear, Headache
Clinical narrative: Patient started with ?normal? pain at injection site and feeling tired. By mid day the day after the vaccine, he had a headache, chills, body aches, low fever, no appetite. By 8:00 pm on day after vaccine, he was vomiting and fever was over 103.5, even with Ibuprofen and alternated Tylenol. I was very scared because I didn?t know if he would keep getting worse. By noon the following day (appx 48 hours after the booster), his symptoms were completely gone. No fever, no pain, able to eat.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia, Vomiting
Clinical narrative: Patient started with ?normal? pain at injection site and feeling tired. By mid day the day after the vaccine, he had a headache, chills, body aches, low fever, no appetite. By 8:00 pm on day after vaccine, he was vomiting and fever was over 103.5, even with Ibuprofen and alternated Tylenol. I was very scared because I didn?t know if he would keep getting worse. By noon the following day (appx 48 hours after the booster), his symptoms were completely gone. No fever, no pain, able to eat.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Polymyalgia rheumatica, Vaccine breakthrough infection
Clinical narrative: Got breakthrough 6 weeks later; recovered and then got Polymylagia Rhumatice immediately after recovering from breakthrough
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Dermatitis, Erythema, Fatigue
Clinical narrative: I got my shot at 11am on the 18th. There were no immediate symptoms so I went home and went about my day. Around an hour after my arm started to get sore and I felt tired. I started to get some small hives on my legs and I was itchy all over. By the next morning my whole left arm, left armpit, and back was really sore and I was itchy mainly on my neck. I started to notice bumps on my neck that have slowly grown. The whole second day I was very itchy allover and was very tired. By the third day (the day I am reporting this) my left shoulder and armpit still hurt and the bumps on my neck are still there. By the evening when I went to take a shower I noticed my whole entire legs were red and inflamed and I was severely itchy from head to toe. The shower did not help with the itchiness and the severity of the itchiness has only gotten worse and the hive breakouts have gotten worse as well.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: I got my shot at 11am on the 18th. There were no immediate symptoms so I went home and went about my day. Around an hour after my arm started to get sore and I felt tired. I started to get some small hives on my legs and I was itchy all over. By the next morning my whole left arm, left armpit, and back was really sore and I was itchy mainly on my neck. I started to notice bumps on my neck that have slowly grown. The whole second day I was very itchy allover and was very tired. By the third day (the day I am reporting this) my left shoulder and armpit still hurt and the bumps on my neck are still there. By the evening when I went to take a shower I noticed my whole entire legs were red and inflamed and I was severely itchy from head to toe. The shower did not help with the itchiness and the severity of the itchiness has only gotten worse and the hive breakouts have gotten worse as well.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Fatigue, Myalgia
Clinical narrative: Fatigue, muscle and joint pain throughout entire body. No relief in 10+ months
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Full body rash
Sex: U
Vaccine: DTAP, FLU4
Symptoms: Asthenia, Blood pressure abnormal, Fatigue, Hypertension, Nausea
Clinical narrative: PAtient presented  After  vaccine: Nausea , weak FatiGue  HBP  143/91
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Pyrexia, Rash, Vaccination site swelling
Clinical narrative: Swelling of Left arm at vaccine   site   and  patient experience  fever for  few days   after vaccine Pt counseled  to take  tylenol  for  fever  and  follow  up  with  his  her  primary doctor. The  swelling  has  gone  down  since  the  shot  date.  Also,  pt  just  remembered she  developed  rashes couple days after  1st  shot,  but  she  thought  it  was  unrelated  to  vaccine  at the time. I let  her  know  that  she may  be  allergic  to the vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident, Chills, Computerised tomogram, Fatigue
Clinical narrative: Patient had Covid in November 2020, recovered & tested postive for the Antibodies. On the morning/early afternoon of 3/4/2020 her took the 2nd dose of the Pfizer vaccine and became violent ill early that evening. He was throwing up and his entire body was on fire to the touch, but he had no fever. the subsequent 5-7 days he was ill (chills, aches, fatigue), much the same as when he had Covid the prior November. Approximately 2 weeks after these Covid like symptoms subsided (3/27/2021), Patient had felt off later in mid-day but could not pin point the feeling he was experiencing, a few hours later he felt fine, he ate dinner later that evening and went to bed. The next morning (3/28/21) he woke up and commented her didn't have any peripheral vision in his right eye and he had, as he said "massive headache". His wife drove him to Medical Center where he was told he was in "AFib" and after tests it was determined he had suffered a mild stroke, which ultimately took his right eye outer peripheral vison where his left eye inside peripheral vison and also left him short term memory, recall issues. Patient has no family history of "Afib" and he himself has never been diagnosed with "Afib" or an irregular heartbeat. The coincidence of this stroke happening on the heals of a severe iliness reaction to the 2nd Pfizer vaccine is too much to ignore.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Laboratory test abnormal, Magnetic resonance imaging
Clinical narrative: Patient had Covid in November 2020, recovered & tested postive for the Antibodies. On the morning/early afternoon of 3/4/2020 her took the 2nd dose of the Pfizer vaccine and became violent ill early that evening. He was throwing up and his entire body was on fire to the touch, but he had no fever. the subsequent 5-7 days he was ill (chills, aches, fatigue), much the same as when he had Covid the prior November. Approximately 2 weeks after these Covid like symptoms subsided (3/27/2021), Patient had felt off later in mid-day but could not pin point the feeling he was experiencing, a few hours later he felt fine, he ate dinner later that evening and went to bed. The next morning (3/28/21) he woke up and commented her didn't have any peripheral vision in his right eye and he had, as he said "massive headache". His wife drove him to Medical Center where he was told he was in "AFib" and after tests it was determined he had suffered a mild stroke, which ultimately took his right eye outer peripheral vison where his left eye inside peripheral vison and also left him short term memory, recall issues. Patient has no family history of "Afib" and he himself has never been diagnosed with "Afib" or an irregular heartbeat. The coincidence of this stroke happening on the heals of a severe iliness reaction to the 2nd Pfizer vaccine is too much to ignore.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Memory impairment, Pain, Skin warm, Visual field defect
Clinical narrative: Patient had Covid in November 2020, recovered & tested postive for the Antibodies. On the morning/early afternoon of 3/4/2020 her took the 2nd dose of the Pfizer vaccine and became violent ill early that evening. He was throwing up and his entire body was on fire to the touch, but he had no fever. the subsequent 5-7 days he was ill (chills, aches, fatigue), much the same as when he had Covid the prior November. Approximately 2 weeks after these Covid like symptoms subsided (3/27/2021), Patient had felt off later in mid-day but could not pin point the feeling he was experiencing, a few hours later he felt fine, he ate dinner later that evening and went to bed. The next morning (3/28/21) he woke up and commented her didn't have any peripheral vision in his right eye and he had, as he said "massive headache". His wife drove him to Medical Center where he was told he was in "AFib" and after tests it was determined he had suffered a mild stroke, which ultimately took his right eye outer peripheral vison where his left eye inside peripheral vison and also left him short term memory, recall issues. Patient has no family history of "Afib" and he himself has never been diagnosed with "Afib" or an irregular heartbeat. The coincidence of this stroke happening on the heals of a severe iliness reaction to the 2nd Pfizer vaccine is too much to ignore.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: Patient had Covid in November 2020, recovered & tested postive for the Antibodies. On the morning/early afternoon of 3/4/2020 her took the 2nd dose of the Pfizer vaccine and became violent ill early that evening. He was throwing up and his entire body was on fire to the touch, but he had no fever. the subsequent 5-7 days he was ill (chills, aches, fatigue), much the same as when he had Covid the prior November. Approximately 2 weeks after these Covid like symptoms subsided (3/27/2021), Patient had felt off later in mid-day but could not pin point the feeling he was experiencing, a few hours later he felt fine, he ate dinner later that evening and went to bed. The next morning (3/28/21) he woke up and commented her didn't have any peripheral vision in his right eye and he had, as he said "massive headache". His wife drove him to Medical Center where he was told he was in "AFib" and after tests it was determined he had suffered a mild stroke, which ultimately took his right eye outer peripheral vison where his left eye inside peripheral vison and also left him short term memory, recall issues. Patient has no family history of "Afib" and he himself has never been diagnosed with "Afib" or an irregular heartbeat. The coincidence of this stroke happening on the heals of a severe iliness reaction to the 2nd Pfizer vaccine is too much to ignore.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 0.2 ml of Pfizer Bio-tech COVID-19 vaccine for ages 12y & older given instead of pediatric vial for children 5-11 years.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 0.2 ml of Pfizer Bio-tech COVID-19 vaccine for ages 12y & older given instead of pediatric vial for children 5-11 years.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 0.2 ml of Pfizer Bio-tech COVID-19 vaccine for ages 12y & older given instead of pediatric vial for children 5-11 years.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 0.2 ml of Pfizer Bio-tech COVID-19 vaccine for ages 12y & older given instead of pediatric vial for children 5-11 years.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Hypersensitivity, Palpitations
Clinical narrative: Patient presenting to the emergency room with a chief complaint of racing heart rate, dizziness and chest pressure. Patient did have allergic reaction to COVID-19 vaccination 3 days ago but states she has been doing well since then. Treated and released. Event occured 3 days after COVID vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness, Blood pressure decreased, Nausea
Clinical narrative: Within 1-2 minutes of receiving the shot, my blood pressure dropped, I lost my vision, and I felt very week. EMS responded and laid me down in the back of my car (this was at the mass public vaccination site). I felt like I started to recover and tried to sit up and move to the driver's seat, but I felt weak and nauseous, so I was taken by ambulance to the hospital. I was discharged about an hour or two later.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Chest pain, Chills, Chronic kidney disease, Fatigue
Clinical narrative: Patient states that was in her usual state of health until  past Thursday 3/18/21 when she had her second dose of moderna COVID 19 vaccine. After this she started feeling tired, with chills and subjective fevers. Then 2 days ago (on Sunday) presented with chest pain with deep inspiration and also exacerbated with supine position. She was admitted with suspected pericarditis.  Not treated with NSAIDs or colchicine due to AKI.  IVFs given.   Recommended avoidance of nonsteroidal anti-inflammatory drugs given suspected underlying chronic kidney disease
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Pericarditis, Pyrexia
Clinical narrative: Patient states that was in her usual state of health until  past Thursday 3/18/21 when she had her second dose of moderna COVID 19 vaccine. After this she started feeling tired, with chills and subjective fevers. Then 2 days ago (on Sunday) presented with chest pain with deep inspiration and also exacerbated with supine position. She was admitted with suspected pericarditis.  Not treated with NSAIDs or colchicine due to AKI.  IVFs given.   Recommended avoidance of nonsteroidal anti-inflammatory drugs given suspected underlying chronic kidney disease
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal abscess, Malnutrition, Nausea, Vomiting
Clinical narrative: Patient presented to the ED on 8/9 for nausea and vomiting. Then patient presented to the ED on 8/25/21 and was subsequently hospitalized for intra-abdominal abscess & Moderate protein-calorie malnutrition . These visits are within 6 weeks of receiving covid vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: BROKE OUT IN SEVERA HIVES ALL OVER BODY THE NEXT DAY. JAW AND LIPS SWELL UP. TERRIBLY ITCHING ALL OVER BODY.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac arrest, Cardiac disorder, Death, Dialysis
Clinical narrative: tested positive for COVID 10 days ago in (Privacy); quarantined x 10 dys; flew home today; while at airport, began to have respiratory complaints; acute mental status changes, slurred speech and left arm weakness; was brought to ED; pt required intubation; tested positive for COVID; tests unremarkable for CVA; transferred to ICU; started on ABX; renal failure worsened; required TPN and dialysis; experienced cardiac changes during dialysis and went into cardiac arrest; pt did not survive; he died in the hospital
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Endotracheal intubation, Intensive care, Laboratory test normal, Mental status changes
Clinical narrative: tested positive for COVID 10 days ago in (Privacy); quarantined x 10 dys; flew home today; while at airport, began to have respiratory complaints; acute mental status changes, slurred speech and left arm weakness; was brought to ED; pt required intubation; tested positive for COVID; tests unremarkable for CVA; transferred to ICU; started on ABX; renal failure worsened; required TPN and dialysis; experienced cardiac changes during dialysis and went into cardiac arrest; pt did not survive; he died in the hospital
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Parenteral nutrition, Renal failure, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID 10 days ago in (Privacy); quarantined x 10 dys; flew home today; while at airport, began to have respiratory complaints; acute mental status changes, slurred speech and left arm weakness; was brought to ED; pt required intubation; tested positive for COVID; tests unremarkable for CVA; transferred to ICU; started on ABX; renal failure worsened; required TPN and dialysis; experienced cardiac changes during dialysis and went into cardiac arrest; pt did not survive; he died in the hospital
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Limb discomfort
Clinical narrative: "The first day" after receiving the first dose of Pfizer COVID vaccine on 02/28/22, the client reported that she had difficulty taking deep breaths. Client added that she still cannot take deep breath but did not follow-up with her primary care provider with hopes it would go away. Client reported she has allergies to bananas, aspirin and nuts which cause rash and urge to cough. Client reported that she had COVID infection in December 2021 and experienced shortness of breath including about 80% loss of taste and smell. Client reported she takes Synthroid 25mg and birth control. At 12:37PM, nurse submitted a medical consult via text message to the Clinical Project Coordinator requesting to proceed with the second dose of Pfizer COVID vaccine. Per Dr. (Privacy), approval to proceed with the second dose of Pfizer COVID vaccine was obtained from medical consult team via text message from (Privacy), Clinical Project Coordinator. Client received the second dose of Pfizer COVID vaccine lot# FK9895 at 1:01 PM. Vaccinator nurse educated client on possible adverse effects, when to seek medical care and register on smartphone based tool. Client did not report any signs and symptoms during the 30 minutes observation period. Client left the vaccination site at 1:35 PM in steady gait.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: "The first day" after receiving the first dose of Pfizer COVID vaccine on 02/28/22, the client reported that she had difficulty taking deep breaths. Client added that she still cannot take deep breath but did not follow-up with her primary care provider with hopes it would go away. Client reported she has allergies to bananas, aspirin and nuts which cause rash and urge to cough. Client reported that she had COVID infection in December 2021 and experienced shortness of breath including about 80% loss of taste and smell. Client reported she takes Synthroid 25mg and birth control. At 12:37PM, nurse submitted a medical consult via text message to the Clinical Project Coordinator requesting to proceed with the second dose of Pfizer COVID vaccine. Per Dr. (Privacy), approval to proceed with the second dose of Pfizer COVID vaccine was obtained from medical consult team via text message from (Privacy), Clinical Project Coordinator. Client received the second dose of Pfizer COVID vaccine lot# FK9895 at 1:01 PM. Vaccinator nurse educated client on possible adverse effects, when to seek medical care and register on smartphone based tool. Client did not report any signs and symptoms during the 30 minutes observation period. Client left the vaccination site at 1:35 PM in steady gait.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient recieved a vaccine from  pfizer (5-11) yr vial that was not diluted (reconstituted). Patient recieved a much higher dose. patient had typical reactions from the vaccine and patient is fine and has no adverse reactions
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient recieved a vaccine from  pfizer (5-11) yr vial that was not diluted (reconstituted). Patient recieved a much higher dose. patient had typical reactions from the vaccine and patient is fine and has no adverse reactions
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: On 10/21/2021 I woke up to a whooshing sound in my head. As the day continued I noticed a ringing in my ears. I didn't think much of it and thought it would go away by the end of the day. It continues until this day non stop. On 10/24 mid day I began to feel off like I had lost my mood but I wasn't in a bad mood or upset. I then began to have visual distortions like things were flat or like my sensory information that my eyes sent to my brain was off. I tried to sleep it off for most of the day but woke up on 10/25 and noticed that I was sensitive to lights. Car head lights looked like they had a really bright halo around them with thousands of small lines coming from it. Later that evening when I returned home from work I took a walk with my daughter and everything started to look like it was moving but it wasn't. This lasted for 10-15 minutes then went away. Between 11/8 and 11/10 I would have an intense feeling in my head or blankness and it felt like the sensory part of my brain that processes visuals and emotional response had a blockage. These episodes would last for a while before they would subside. After that I have been having issues with how things look. They almost look like I'm watching them through a camera. It seems like my brain is not receiving or processing visual stimulation or natural reaction to visual responses is off. In certain situations everything looks flat and it lasts for a while. I have had insomnia since October along with the ringing in the ears. I constantly have trouble with how my brain is processing things like stimulus and it feel like my brain has trouble processing emotional responses to everything.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Insomnia, Metamorphopsia, Photophobia, Sensory processing disorder
Clinical narrative: On 10/21/2021 I woke up to a whooshing sound in my head. As the day continued I noticed a ringing in my ears. I didn't think much of it and thought it would go away by the end of the day. It continues until this day non stop. On 10/24 mid day I began to feel off like I had lost my mood but I wasn't in a bad mood or upset. I then began to have visual distortions like things were flat or like my sensory information that my eyes sent to my brain was off. I tried to sleep it off for most of the day but woke up on 10/25 and noticed that I was sensitive to lights. Car head lights looked like they had a really bright halo around them with thousands of small lines coming from it. Later that evening when I returned home from work I took a walk with my daughter and everything started to look like it was moving but it wasn't. This lasted for 10-15 minutes then went away. Between 11/8 and 11/10 I would have an intense feeling in my head or blankness and it felt like the sensory part of my brain that processes visuals and emotional response had a blockage. These episodes would last for a while before they would subside. After that I have been having issues with how things look. They almost look like I'm watching them through a camera. It seems like my brain is not receiving or processing visual stimulation or natural reaction to visual responses is off. In certain situations everything looks flat and it lasts for a while. I have had insomnia since October along with the ringing in the ears. I constantly have trouble with how my brain is processing things like stimulus and it feel like my brain has trouble processing emotional responses to everything.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Visual impairment
Clinical narrative: On 10/21/2021 I woke up to a whooshing sound in my head. As the day continued I noticed a ringing in my ears. I didn't think much of it and thought it would go away by the end of the day. It continues until this day non stop. On 10/24 mid day I began to feel off like I had lost my mood but I wasn't in a bad mood or upset. I then began to have visual distortions like things were flat or like my sensory information that my eyes sent to my brain was off. I tried to sleep it off for most of the day but woke up on 10/25 and noticed that I was sensitive to lights. Car head lights looked like they had a really bright halo around them with thousands of small lines coming from it. Later that evening when I returned home from work I took a walk with my daughter and everything started to look like it was moving but it wasn't. This lasted for 10-15 minutes then went away. Between 11/8 and 11/10 I would have an intense feeling in my head or blankness and it felt like the sensory part of my brain that processes visuals and emotional response had a blockage. These episodes would last for a while before they would subside. After that I have been having issues with how things look. They almost look like I'm watching them through a camera. It seems like my brain is not receiving or processing visual stimulation or natural reaction to visual responses is off. In certain situations everything looks flat and it lasts for a while. I have had insomnia since October along with the ringing in the ears. I constantly have trouble with how my brain is processing things like stimulus and it feel like my brain has trouble processing emotional responses to everything.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Mobility decreased, Skin swelling
Clinical narrative: lumps under right arm; arm was so sore; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lumps under right arm) and PAIN IN EXTREMITY (arm was so sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced AXILLARY MASS (lumps under right arm). In 2021, the patient experienced PAIN IN EXTREMITY (arm was so sore). In 2021, PAIN IN EXTREMITY (arm was so sore) had resolved. At the time of the report, AXILLARY MASS (lumps under right arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not take any medications. It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient reported that that when she got the shot, she had lumps under her right arm. It happened right away. She thought it happened after the first dose, but it happened at the pharmacy where she was injected. Patient's arm was sore. It went away probably a week after. It did not hang around that long.    This case was linked to MOD-2022-513262 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Pain in extremity
Clinical narrative: lumps under right arm; arm was so sore; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lumps under right arm) and PAIN IN EXTREMITY (arm was so sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced AXILLARY MASS (lumps under right arm). In 2021, the patient experienced PAIN IN EXTREMITY (arm was so sore). In 2021, PAIN IN EXTREMITY (arm was so sore) had resolved. At the time of the report, AXILLARY MASS (lumps under right arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not take any medications. It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient reported that that when she got the shot, she had lumps under her right arm. It happened right away. She thought it happened after the first dose, but it happened at the pharmacy where she was injected. Patient's arm was sore. It went away probably a week after. It did not hang around that long.    This case was linked to MOD-2022-513262 (Patient Link).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Decreased appetite, Dysuria, Fibromyalgia, Headache
Clinical narrative: Nausea; Vomiting; Fever; Headache; Muscular pain; loss of apetite; Urinating discomfort; Pelvic pain after urination; decreased mobility, left arm/cannot even hold the phone with my left arm.; Fibromyalgia; sick she felt for 3 days; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 29th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injected limb mobility decreased, nausea, headache, muscle pain, appetite lost, painful urination and pelvic pain were not recovered/not resolved and the outcome of the fibromyalgia worsened was unknown and the outcome of the malaise, vomiting and fever were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain to be related to Shingrix.  Additional details were provided as follows: The patient that received her 1st dose of Shingrix vaccine in her left arm. The patient was suffering from fibromyalgia.   The patient reported that, she did not get the 2nd dose of Shingrix because she had to take the COVID vaccine and because she felt sick for 3 days. The patient had all the symptoms written in the vaccine sheet. The patient reported nausea, vomiting, fever, headache, muscular pain, loss of appetite, urinating discomfort with pelvic pain after urination.  The patient reported decreased mobility of her left arm and she could not even hold the phone with her left arm. She took Tylenol at that time.  The patient reports that she still had the following symptoms of headache, loss of appetite, nausea, muscular pain, decreased mobility of her left arm, that had not resolved. The patient reported her fibromyalgia had gotten worsen. The patient reported she had not taken a vaccine in her left arm since then. Not all information was available, lot and expiration date were unknown.  The patient consent to follow up with health care professional(HCP) and would follow up with HCP phone information. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Malaise, Myalgia, Nausea, Pelvic pain
Clinical narrative: Nausea; Vomiting; Fever; Headache; Muscular pain; loss of apetite; Urinating discomfort; Pelvic pain after urination; decreased mobility, left arm/cannot even hold the phone with my left arm.; Fibromyalgia; sick she felt for 3 days; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 29th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injected limb mobility decreased, nausea, headache, muscle pain, appetite lost, painful urination and pelvic pain were not recovered/not resolved and the outcome of the fibromyalgia worsened was unknown and the outcome of the malaise, vomiting and fever were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain to be related to Shingrix.  Additional details were provided as follows: The patient that received her 1st dose of Shingrix vaccine in her left arm. The patient was suffering from fibromyalgia.   The patient reported that, she did not get the 2nd dose of Shingrix because she had to take the COVID vaccine and because she felt sick for 3 days. The patient had all the symptoms written in the vaccine sheet. The patient reported nausea, vomiting, fever, headache, muscular pain, loss of appetite, urinating discomfort with pelvic pain after urination.  The patient reported decreased mobility of her left arm and she could not even hold the phone with her left arm. She took Tylenol at that time.  The patient reports that she still had the following symptoms of headache, loss of appetite, nausea, muscular pain, decreased mobility of her left arm, that had not resolved. The patient reported her fibromyalgia had gotten worsen. The patient reported she had not taken a vaccine in her left arm since then. Not all information was available, lot and expiration date were unknown.  The patient consent to follow up with health care professional(HCP) and would follow up with HCP phone information. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Fever; Headache; Muscular pain; loss of apetite; Urinating discomfort; Pelvic pain after urination; decreased mobility, left arm/cannot even hold the phone with my left arm.; Fibromyalgia; sick she felt for 3 days; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 29th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injected limb mobility decreased, nausea, headache, muscle pain, appetite lost, painful urination and pelvic pain were not recovered/not resolved and the outcome of the fibromyalgia worsened was unknown and the outcome of the malaise, vomiting and fever were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain to be related to Shingrix.  Additional details were provided as follows: The patient that received her 1st dose of Shingrix vaccine in her left arm. The patient was suffering from fibromyalgia.   The patient reported that, she did not get the 2nd dose of Shingrix because she had to take the COVID vaccine and because she felt sick for 3 days. The patient had all the symptoms written in the vaccine sheet. The patient reported nausea, vomiting, fever, headache, muscular pain, loss of appetite, urinating discomfort with pelvic pain after urination.  The patient reported decreased mobility of her left arm and she could not even hold the phone with her left arm. She took Tylenol at that time.  The patient reports that she still had the following symptoms of headache, loss of appetite, nausea, muscular pain, decreased mobility of her left arm, that had not resolved. The patient reported her fibromyalgia had gotten worsen. The patient reported she had not taken a vaccine in her left arm since then. Not all information was available, lot and expiration date were unknown.  The patient consent to follow up with health care professional(HCP) and would follow up with HCP phone information. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient received vaccine as a booster dose and does not have information available on the patients first two doses. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit Vial moved from freezer to refrigerator on 3-MAR-2022. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy prostate abnormal, Magnetic resonance imaging abnormal, Prostate cancer
Clinical narrative: Diagnosis of prostate cancer, Gleason score 6+7 and 6.  No family history of any type of cancers, discovered during a regular screening.  No symptoms or signs.  Scheduled for IRE on April 5, 2022
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Swelling, mild pain and sensitivity to touch.  Has yet to stop 5 days later.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Mechanical urticaria, Urticaria
Clinical narrative: Chronic hives randomly broke out all over my body 12 days after booster shot Difficulty breathing on episodic periods for 30 days Chest muscles constricting for episodic periods   Prednisone was administered for 3 months Regiment of double daily dose Zyrtec in an 2 benedryl twice a day Two hydroxyzine twice a day  Hives stoped after 3 months  Dermagraphiga still present 6 months later
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Allergy test positive, Food allergy, Impaired quality of life, Milk allergy, Wound
Clinical narrative: Severe, uncontrollable open-wound eczema on the face and body that did not respond to pharmaceuticals. Months of prescription ointments, specialists, and poor quality of life for baby. Skin irritation began the morning after vaccine. He was only supposed to get the Dtap (which he had a moderate skin reaction to at 4 months, resolved after 2 months) his doctor called me after we got home and said the wrong vaccine was given: combo  Pediarix
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Severe, uncontrollable open-wound eczema on the face and body that did not respond to pharmaceuticals. Months of prescription ointments, specialists, and poor quality of life for baby. Skin irritation began the morning after vaccine. He was only supposed to get the Dtap (which he had a moderate skin reaction to at 4 months, resolved after 2 months) his doctor called me after we got home and said the wrong vaccine was given: combo  Pediarix
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Heavy menstrual bleeding, International normalised ratio, Metabolic function test, Prothrombin level
Clinical narrative: Increased menstral bleeding & excessive clotting beginning the day after receiving the Covid booster. Bleeding continued for approximately 6 weeks, with cessation of abnormal bleeding for approximately 5 weeks, followed by active uterine hemorrhaging resulting in 2 day hospital stay requiring blood transfusions & additional medications to attempt cessation of bleeding. Uterine hemorrhaging during this episode lasted approximately 12 days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time, Thrombosis, Transfusion, Ultrasound pelvis, Uterine haemorrhage
Clinical narrative: Increased menstral bleeding & excessive clotting beginning the day after receiving the Covid booster. Bleeding continued for approximately 6 weeks, with cessation of abnormal bleeding for approximately 5 weeks, followed by active uterine hemorrhaging resulting in 2 day hospital stay requiring blood transfusions & additional medications to attempt cessation of bleeding. Uterine hemorrhaging during this episode lasted approximately 12 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th January 2022, 1 days after receiving Shingrix, the patient experienced headache and pain in arm. On 5th January 2022, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022046148  Additional details were provided as follows: The case was self reported by the patient. The patient received first dose of Shingrix vaccine and day after she got her first Shingrix vaccine, she had a headache and arm soreness in the arm she got her vaccine in (right arm). The patient reported that, headache only lasted about a day and the sore arm lasted about a week. The reporter did not consent to follow up.  This case was linked with US2022046148 reported by same reporter for same patient for second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046148:Same reporter.