chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: I started to develop symptoms of shingles 7 days after my vaccine (vaccine was 2/16/2021, symptoms started 2/23/2021). It started as slight itchiness and tenderness. On 2/26/2021 I woke up with a pretty swollen eye which alerted me to make a virtual visit with a Nurse Practitioner at my Dr's office. The same day I got a Covid test (both rapid antigen and PCR -- both came back negative) and eventually was seen at an urgent care. The urgent care took a sample of the shingles, based on observation the provider stated they thought it was shingles. I was prescribed valacyclovir. It was later confirmed to be shingles. After about a week the symptoms subsided.  During this time I had a mild/severe headache for about 7-9 days as well. The shingles was only on my left eyelid and left eyebrow. It caused swelling, redness and tenderness. The rash did blister at certain areas. The shingles did not seem to infect my eyeball. I followed up with an Ophthalmologist to confirm that the shingles did not affect my vision.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Constipation, Dysphagia, Fatigue, Feeling abnormal
Clinical narrative: Developed hypothyroid symptoms: hair loss, brain fog, constipation, trouble swallowing, fatigue
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Since I have received the vaccine, I have experienced occasional and random tinnitus. I usually notice this a couple of times a day
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, COVID-19, Cognitive disorder, Cognitive test, Computerised tomogram normal
Clinical narrative: I am having cognitive problems (Anaphase, Brain Fog, and memory etc. and other health related issues as well) associated with my Moderna Vaccinations and after having covid and after my booster shot.  I am currently under medical doctor of Neurology and have had a second appion from another medical doctor of MD Neurology.   It is not in my best interest to keep getting boosters when each time I have more stroke- like problems as mentioned above.    Past tests.  I have lots of blood work done.  CAT Scan clear and normal.  Spinal Tap normal, EEG done.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Electroencephalogram, Feeling abnormal, Lumbar puncture normal, Memory impairment
Clinical narrative: I am having cognitive problems (Anaphase, Brain Fog, and memory etc. and other health related issues as well) associated with my Moderna Vaccinations and after having covid and after my booster shot.  I am currently under medical doctor of Neurology and have had a second appion from another medical doctor of MD Neurology.   It is not in my best interest to keep getting boosters when each time I have more stroke- like problems as mentioned above.    Past tests.  I have lots of blood work done.  CAT Scan clear and normal.  Spinal Tap normal, EEG done.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom, SARS-CoV-2 test positive
Clinical narrative: I am having cognitive problems (Anaphase, Brain Fog, and memory etc. and other health related issues as well) associated with my Moderna Vaccinations and after having covid and after my booster shot.  I am currently under medical doctor of Neurology and have had a second appion from another medical doctor of MD Neurology.   It is not in my best interest to keep getting boosters when each time I have more stroke- like problems as mentioned above.    Past tests.  I have lots of blood work done.  CAT Scan clear and normal.  Spinal Tap normal, EEG done.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Client presented to the vaccination site on 1/2/2022 and received 1st dose of Pfizer COVID vaccine lot #FL3198 at approximately 12:45. Client reported as he was walking out of the observation room at 12:55 he felt faint, client then returned to observation room to sit down. At 13:00 RN provided client with a juice, client drank half and immediately vomited, RN had client sit in a chair. RN took vitals at 13:06: BP - 110/74, HR - 68, SpO2 - 98%, RR - 12, A&Ox4. Lead RN instructed client take off face mask. Client reports no health history or allergies, client states "I have not eaten today and when I got up to leave I felt very hungry all of a sudden and then felt faint and that's why I came back to observation". Client declined another set of vitals to be taken and stated "I'm fine I'm just embarrassed". Lead RN educated client on possible adverse reactions, when to seek medical care and to register with V-Safe. The client left the vaccination site at 13:10 A&Ox4 with a steady gait.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Menstruation irregular, Myalgia
Clinical narrative: Patient got first dose of vaccine, and first period afterwards (roughly 2-3 weeks) was significantly more severe, with additional bleeding and pain. Since then,  patient has had more frequent periods with significantly worsened cramps/bleeding/fatigue/muscle aches/two fevers associated with periods since then.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Smear cervix
Clinical narrative: Patient got first dose of vaccine, and first period afterwards (roughly 2-3 weeks) was significantly more severe, with additional bleeding and pain. Since then,  patient has had more frequent periods with significantly worsened cramps/bleeding/fatigue/muscle aches/two fevers associated with periods since then.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Insomnia, Pain
Clinical narrative: Headache, aches, very hot and very cold, insomnia
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: body aches, shivers, tired active symptoms; began at 2 p.m. 1/27/22
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient looked like she started to have a seizure and started to foam in the mouth for 3 to 5 seconds. Then she came to and started feeling better. Patient reported that this happened during her first vaccine. This did not happen during the second vaccine. The booster (this RX) did cause her to have a seizure. by the time paramedics came, she was feeling much better. no treatment necessary.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I am breaking out in hives and I am very itchy
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: A large lump has developed on the side of the neck near the esophogus.  No treatment has been sought yet.  Just waiting to see if it gets worse necessitating a trip to the ER. The lump developed around 6 pm on January 27, 2022.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus  onset within 1 day of receiving booster
Age: 64.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Adverse reaction
Clinical narrative: its been a year since  I contacted your reporting adverse program with my issues and along with the medical professionals dont seem to hear me
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Neck pain, Pain in extremity, Urticaria
Clinical narrative: pain, in arms, back, neck  and headaches, for days full body hives on day 5
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative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
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles following the 3rd dose of Moderna vaccine administered about 3 weeks before the onset of symptoms.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Feeling cold, Nausea
Clinical narrative: Nausea - From time of injection to end of day (approx. 9:45 am - 11:00 pm) - Mild Chills, feeling feverish - About 3-4 hours after injection, noticed around 1:00 pm. Mild at this point. Felt slightly cold, a little shake.  At approx. 5:00 pm, symptoms steadily worsened, to the point of being unable to hold objects nor perform basic tasks such as writing. I was unable to warm myself, even when wearing a winter jacket to bed under layers of blankets. This continued into the next day after I'd slept, though not as bad as the night before. The next morning (approx. 8:00 am), I was shaky, but still able to hold objects and write steadily. I was no longer feeling cold in the morning.  Breathing difficulties - pains in chest. Still present, off and on. Mild (as of now). On day of injection/dose, occasional pangs of pain in chest area- moderate pain for approx. 36-48 hours after injection/dose.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Nausea - From time of injection to end of day (approx. 9:45 am - 11:00 pm) - Mild Chills, feeling feverish - About 3-4 hours after injection, noticed around 1:00 pm. Mild at this point. Felt slightly cold, a little shake.  At approx. 5:00 pm, symptoms steadily worsened, to the point of being unable to hold objects nor perform basic tasks such as writing. I was unable to warm myself, even when wearing a winter jacket to bed under layers of blankets. This continued into the next day after I'd slept, though not as bad as the night before. The next morning (approx. 8:00 am), I was shaky, but still able to hold objects and write steadily. I was no longer feeling cold in the morning.  Breathing difficulties - pains in chest. Still present, off and on. Mild (as of now). On day of injection/dose, occasional pangs of pain in chest area- moderate pain for approx. 36-48 hours after injection/dose.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative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
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative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
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: I got my Moderna COVID-19 booster on 12/17/21.  On 12/31/21, I started feeling itchy throughout my body and where ever I would scratch, welts/hives would form. The welts are very itchy and would go away about a half hour later. I went to my PCP on 1/5/21 and he told me I have dermatographia. I received an IM Decadron 6mg injection in office and prescriptions for prednisone 20 mg taper and hydroxyzine 25 mg prn. Upon completion of the prednisone taper, my dermatographia was still present and persisted to the time of this report, about a month later. I have been since taking Allegra and cetirizine prn for the urticaria.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Menstruation irregular
Clinical narrative: Severe lower abdominal cramping, similar to menstrual cramping but 10x worse. Experienced this cramping on and off for approximately 2 weeks. Following these symptoms  I then missed my period, which was abnormal for me considering I have been regular for years. I eventually got my period back, which it hasn?t been the same since.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Headache, Nausea, Pain
Clinical narrative: Fever, HA, confusion, nausea, weakness and aches.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, HA, confusion, nausea, weakness and aches.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: 12/31/2021: began experiencing sore throat. Treated with throat lozenges 01/02/2022: began experiencing nasal congestion and headache 01/03/2022: began experiencing cough. Treated with OTC cold medication (Day-Quil/Ny-Quil) 01/04/2022: congestion, cough, and headache became more severe. Also became more fatigued/tired. Received COVID-19, PCR test. Continued treatment of throat lozenges, cold medication and ibuprofen. 01/05/2022: received positive result of COVID-19 test. 01/06/2022: lost sense of taste/smell 01/08/2022: congestion, headache, and fatigue began to subside 01/19/2022: taste/smell began to return As of 01/27/22: cough still remains, at times severe, but not as constant
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: 12/31/2021: began experiencing sore throat. Treated with throat lozenges 01/02/2022: began experiencing nasal congestion and headache 01/03/2022: began experiencing cough. Treated with OTC cold medication (Day-Quil/Ny-Quil) 01/04/2022: congestion, cough, and headache became more severe. Also became more fatigued/tired. Received COVID-19, PCR test. Continued treatment of throat lozenges, cold medication and ibuprofen. 01/05/2022: received positive result of COVID-19 test. 01/06/2022: lost sense of taste/smell 01/08/2022: congestion, headache, and fatigue began to subside 01/19/2022: taste/smell began to return As of 01/27/22: cough still remains, at times severe, but not as constant
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood urine present, Dysuria, Nephrolithiasis, Urine analysis
Clinical narrative: Kidney stones, extreme abdominal pain, blood in urine, difficult urination -Passed 5 stones two weeks following first dose of vaccine -Passed additional stones one-per-month for 5 straight months
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Kidney stones, extreme abdominal pain, blood in urine, difficult urination -Passed 5 stones two weeks following first dose of vaccine -Passed additional stones one-per-month for 5 straight months
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dysgeusia, Facial paralysis, Headache, Immediate post-injection reaction
Clinical narrative: Matalic taste immediate after shot given 30 min later started having headache. Started having body aches 1600- started feeling (R) facial symptoms tingle, itchy, eye blurry, 1800 (R) facial droop, slured speech, 1900, was in so much pain (R) facial droop, severe pain in body (R) arm where shot was given was in so pain. Next day still had facial drooping, headache body sore. Went to the ER 10/16/21 - for stroke like symptoms
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Pain, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: Matalic taste immediate after shot given 30 min later started having headache. Started having body aches 1600- started feeling (R) facial symptoms tingle, itchy, eye blurry, 1800 (R) facial droop, slured speech, 1900, was in so much pain (R) facial droop, severe pain in body (R) arm where shot was given was in so pain. Next day still had facial drooping, headache body sore. Went to the ER 10/16/21 - for stroke like symptoms
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Matalic taste immediate after shot given 30 min later started having headache. Started having body aches 1600- started feeling (R) facial symptoms tingle, itchy, eye blurry, 1800 (R) facial droop, slured speech, 1900, was in so much pain (R) facial droop, severe pain in body (R) arm where shot was given was in so pain. Next day still had facial drooping, headache body sore. Went to the ER 10/16/21 - for stroke like symptoms
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Booster for immunocompromised patient was given at 0.5ml Moderna instead of 0.25ml. Patient states that she was fine. She had a sore arm and red itchy rash day following vaccination. She got Pfizer the last 3 doses.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cold sweat, Dizziness, Dyspnoea, Hypoaesthesia, Pallor
Clinical narrative: Approx. 10 minutes after vaccination patient was pale, clammy, dizzy and said he was having trouble catching his breath. His breath, he said he had trouble seeing and that his arm felt numb. His mother requested Paramedics be called. While waiting for Paramedics, Pt's Blood Pressure was taken (94/63, 98) Pt was let to drink some water and color came back to his face. Paramedics came approx. 10-15 minutes after and reported normal vitals signs & O2 saturation. Pt left to home.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Visual impairment
Clinical narrative: Approx. 10 minutes after vaccination patient was pale, clammy, dizzy and said he was having trouble catching his breath. His breath, he said he had trouble seeing and that his arm felt numb. His mother requested Paramedics be called. While waiting for Paramedics, Pt's Blood Pressure was taken (94/63, 98) Pt was let to drink some water and color came back to his face. Paramedics came approx. 10-15 minutes after and reported normal vitals signs & O2 saturation. Pt left to home.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Depression, Dyspnoea, Electrocardiogram normal
Clinical narrative: RespDepression chest tightness Narrative:  Pt received 1st dose of COVID-19 vaccine (Pfizer) on 12/27/21, WIthin 10 mins, complained of "know in chest" and some "difficulty breathing." Reported to ED, ECG done and no STEMI. No meds or treatment given, improved on own and discharged home.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Narrative:  Pt reported clinic nurse that he got anaphylaxis from second COVID-19 vaccine that he got from another clinic.  No detail of event has documented in note.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Bronchospasm, Dysphemia, Electrocardiogram normal, Impaired work ability
Clinical narrative: Patient was receiving the booster dose while at work. About 1 hour after vaccine was given, patient started to shake and studder during normal conversation with coworkers. Patient left work and went to  the urgent care. Where they did not perform any tests and sent her home to rest. They told her that this ADR had been reported 51 times and that it would go away in a few days. The next morning (Tuesday 1/25) patient woke up and starting shaking again around 8am, then she started to studder again starting at 11am uncontrollably. The symptoms would only subside during sleep. The next day (Wed 1/26) patient woke up and symptoms persisted and she decided to visit her physician. During her physician visit they performed an EKG and blood work to try and determine what was going on. All test came back normal. The physician determined that she was having bronchial spasms and sent her home with some Hydroxyzine and it should go away in a few days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient was receiving the booster dose while at work. About 1 hour after vaccine was given, patient started to shake and studder during normal conversation with coworkers. Patient left work and went to  the urgent care. Where they did not perform any tests and sent her home to rest. They told her that this ADR had been reported 51 times and that it would go away in a few days. The next morning (Tuesday 1/25) patient woke up and starting shaking again around 8am, then she started to studder again starting at 11am uncontrollably. The symptoms would only subside during sleep. The next day (Wed 1/26) patient woke up and symptoms persisted and she decided to visit her physician. During her physician visit they performed an EKG and blood work to try and determine what was going on. All test came back normal. The physician determined that she was having bronchial spasms and sent her home with some Hydroxyzine and it should go away in a few days.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Endotracheal intubation, Hypersensitivity, Myalgia, Rash, Stevens-Johnson syndrome
Clinical narrative: On sept 26, patient took the flu vaccine. The next day the patient started having muscle pain. The next day started developing a skin rash. On Oct 1, patient was hospitalized and was diagnosed with a severe allergic reaction to the flu vaccine. They patient developed Stephen Iohnson Syndrome. She stayed intubated in the hospital for one month. She had to relearn how to walk and feed herself which took intensely physical therapy. The patient has symptoms from this reactions still today.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Blood test, Computerised tomogram, Contusion
Clinical narrative: I had flu like symptoms. I had lesions and whelps in my mouth. I had a life threatening swollen throat and tongue to where I almost quit breathing. I had onsite chronic debilitating loss of neurological functions like inability complete sentences, find words, pronounce words, or complete thoughts. I was bruising easily across my body between my lips, toes, thighs, and ring finger. I had a development of pain points. I had went through multiple of lifesaving ER and urgent care interventions. I had development of sores and lesions on my tongue, gums, and mouth.  I had inflammation of my lymph system. I had swollen ankles and legs. I had pain points across my body. I had chronic system inflammation. I had intermittent loss of balance. I needed assistance with walking. I had dizziness and intermittent blurred vison. I had upper respiratory issues. I had 2 partially collapsed lungs, shortness of breath, muscle aches, joint aches, depression, fatigue, chronic headaches, and a 35 pound weight gain within 8 weeks. I been on multiple supplements for the entire year. I was given steroids and antihistamines for the first 8 weeks. I still get swelling in my lips and mouth on a regular basis. My right ankle is still swelling. I can't wear my ring. I cant walk long distances. I still struggle with clarity of thinking. I haven't quit breathing, but I do have shortness of breath still.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dizziness, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: I had flu like symptoms. I had lesions and whelps in my mouth. I had a life threatening swollen throat and tongue to where I almost quit breathing. I had onsite chronic debilitating loss of neurological functions like inability complete sentences, find words, pronounce words, or complete thoughts. I was bruising easily across my body between my lips, toes, thighs, and ring finger. I had a development of pain points. I had went through multiple of lifesaving ER and urgent care interventions. I had development of sores and lesions on my tongue, gums, and mouth.  I had inflammation of my lymph system. I had swollen ankles and legs. I had pain points across my body. I had chronic system inflammation. I had intermittent loss of balance. I needed assistance with walking. I had dizziness and intermittent blurred vison. I had upper respiratory issues. I had 2 partially collapsed lungs, shortness of breath, muscle aches, joint aches, depression, fatigue, chronic headaches, and a 35 pound weight gain within 8 weeks. I been on multiple supplements for the entire year. I was given steroids and antihistamines for the first 8 weeks. I still get swelling in my lips and mouth on a regular basis. My right ankle is still swelling. I can't wear my ring. I cant walk long distances. I still struggle with clarity of thinking. I haven't quit breathing, but I do have shortness of breath still.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Headache, Inflammation, Influenza like illness, Joint swelling
Clinical narrative: I had flu like symptoms. I had lesions and whelps in my mouth. I had a life threatening swollen throat and tongue to where I almost quit breathing. I had onsite chronic debilitating loss of neurological functions like inability complete sentences, find words, pronounce words, or complete thoughts. I was bruising easily across my body between my lips, toes, thighs, and ring finger. I had a development of pain points. I had went through multiple of lifesaving ER and urgent care interventions. I had development of sores and lesions on my tongue, gums, and mouth.  I had inflammation of my lymph system. I had swollen ankles and legs. I had pain points across my body. I had chronic system inflammation. I had intermittent loss of balance. I needed assistance with walking. I had dizziness and intermittent blurred vison. I had upper respiratory issues. I had 2 partially collapsed lungs, shortness of breath, muscle aches, joint aches, depression, fatigue, chronic headaches, and a 35 pound weight gain within 8 weeks. I been on multiple supplements for the entire year. I was given steroids and antihistamines for the first 8 weeks. I still get swelling in my lips and mouth on a regular basis. My right ankle is still swelling. I can't wear my ring. I cant walk long distances. I still struggle with clarity of thinking. I haven't quit breathing, but I do have shortness of breath still.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Lung disorder, Mouth swelling, Myalgia, Nervous system disorder
Clinical narrative: I had flu like symptoms. I had lesions and whelps in my mouth. I had a life threatening swollen throat and tongue to where I almost quit breathing. I had onsite chronic debilitating loss of neurological functions like inability complete sentences, find words, pronounce words, or complete thoughts. I was bruising easily across my body between my lips, toes, thighs, and ring finger. I had a development of pain points. I had went through multiple of lifesaving ER and urgent care interventions. I had development of sores and lesions on my tongue, gums, and mouth.  I had inflammation of my lymph system. I had swollen ankles and legs. I had pain points across my body. I had chronic system inflammation. I had intermittent loss of balance. I needed assistance with walking. I had dizziness and intermittent blurred vison. I had upper respiratory issues. I had 2 partially collapsed lungs, shortness of breath, muscle aches, joint aches, depression, fatigue, chronic headaches, and a 35 pound weight gain within 8 weeks. I been on multiple supplements for the entire year. I was given steroids and antihistamines for the first 8 weeks. I still get swelling in my lips and mouth on a regular basis. My right ankle is still swelling. I can't wear my ring. I cant walk long distances. I still struggle with clarity of thinking. I haven't quit breathing, but I do have shortness of breath still.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pharyngeal swelling, Respiratory disorder, Stomatitis
Clinical narrative: I had flu like symptoms. I had lesions and whelps in my mouth. I had a life threatening swollen throat and tongue to where I almost quit breathing. I had onsite chronic debilitating loss of neurological functions like inability complete sentences, find words, pronounce words, or complete thoughts. I was bruising easily across my body between my lips, toes, thighs, and ring finger. I had a development of pain points. I had went through multiple of lifesaving ER and urgent care interventions. I had development of sores and lesions on my tongue, gums, and mouth.  I had inflammation of my lymph system. I had swollen ankles and legs. I had pain points across my body. I had chronic system inflammation. I had intermittent loss of balance. I needed assistance with walking. I had dizziness and intermittent blurred vison. I had upper respiratory issues. I had 2 partially collapsed lungs, shortness of breath, muscle aches, joint aches, depression, fatigue, chronic headaches, and a 35 pound weight gain within 8 weeks. I been on multiple supplements for the entire year. I was given steroids and antihistamines for the first 8 weeks. I still get swelling in my lips and mouth on a regular basis. My right ankle is still swelling. I can't wear my ring. I cant walk long distances. I still struggle with clarity of thinking. I haven't quit breathing, but I do have shortness of breath still.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria, Vision blurred, Weight increased
Clinical narrative: I had flu like symptoms. I had lesions and whelps in my mouth. I had a life threatening swollen throat and tongue to where I almost quit breathing. I had onsite chronic debilitating loss of neurological functions like inability complete sentences, find words, pronounce words, or complete thoughts. I was bruising easily across my body between my lips, toes, thighs, and ring finger. I had a development of pain points. I had went through multiple of lifesaving ER and urgent care interventions. I had development of sores and lesions on my tongue, gums, and mouth.  I had inflammation of my lymph system. I had swollen ankles and legs. I had pain points across my body. I had chronic system inflammation. I had intermittent loss of balance. I needed assistance with walking. I had dizziness and intermittent blurred vison. I had upper respiratory issues. I had 2 partially collapsed lungs, shortness of breath, muscle aches, joint aches, depression, fatigue, chronic headaches, and a 35 pound weight gain within 8 weeks. I been on multiple supplements for the entire year. I was given steroids and antihistamines for the first 8 weeks. I still get swelling in my lips and mouth on a regular basis. My right ankle is still swelling. I can't wear my ring. I cant walk long distances. I still struggle with clarity of thinking. I haven't quit breathing, but I do have shortness of breath still.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Pain, Pain assessment, Pain in extremity
Clinical narrative: painful arm; feels like bone pain; Painful to lift arm or with any movement.; Notices some loss of strength in right arm; This is a spontaneous report received from non-contactable reporter (Other Healthcare Professional).  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in deltoid right, administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Allergy to Sulfa drugs" (unspecified if ongoing); "Skin Psoriasis" (unspecified if ongoing). Concomitant medication included: ESOMEPRAZOLE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Feb2021, outcome "recovered with sequelae" (2021), described as "painful arm"; BONE PAIN (non-serious) with onset 19Feb2021, outcome "recovered with sequelae" (2021), described as "feels like bone pain"; PAIN (non-serious) with onset 19Feb2021, outcome "recovered with sequelae" (2021), described as "Painful to lift arm or with any movement."; ASTHENIA (non-serious) with onset 19Feb2021, outcome "recovered with sequelae" (2021), described as "Notices some loss of strength in right arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, bone pain, pain, asthenia.  Additional Information: The patient was taking concomitant medications which included esomeprazole magnesium (NEXIUM) for unknown indication and oral contraceptive pills (OCP) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since having the vaccine. On 19Feb2021, the patient had experienced painful arm which was continued to have residual arm pain weeks after administration and the patient reported that she felt like bone pain and it was painful to lift arm with any movement. The patient also noticed some loss of strength in right arm. The patient rated pain 3/10 (unspecified units). Adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vital signs measurement
Clinical narrative: She felt faint and needed to lay down; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: ER8730, Expiration Date: Jul2021) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fainting" (unspecified if ongoing), notes: have a history of fainting but not during vaccination. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "She felt faint and needed to lay down". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: In addition to relevant medical history, it was reported that the patient has cardiogenic, reporter thought it was neuropathic which the patient developed later. After the vaccination of the 1st dose, the patient felt faint and she did not pass out but she felt faint and needed to lay down. Emergency services were called. The patient's vitals were checked and she was fine and released. It was reported that as part of the reporter's protocol, when an event occurs they have to determine if revaccination is required. The reporter was querying whether the patient need to be revaccinated.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Additional Details: paramedics were called to assess pt, no further action was determined to be necessary
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Additional Details: paramedics were called to assess pt, no further action was determined to be necessary
Sex: M
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: sinus headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinus headache allergies" (unspecified if ongoing); "sinus headache allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SINUS HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "sinus headache".  Additional information: Patient was cautioned not to take pain medications the day before and the day after the injection. Patient would like to take pseudoephedrine to release the sinus pressure for the sinus headache he has felt coming.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Rash, Skin tightness
Clinical narrative: RED THROAT; TIGHTNESS IN RIGHT AND LEFT CHEEKS AND UNDER EYES; RASH ON NECK/RAISED, NON ITCHY, SLIGHTLY REDDENED AREA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arrhythmia, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergies, atenolol for arrhythmia, and sertraline hydrochloride. On 10-APR-2021, the patient experienced rash on neck/raised, non itchy, slightly reddened area. On an unspecified date, the patient experienced red throat, and tightness in right and left cheeks and under eyes. Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on neck/raised, non itchy, slightly reddened area, and the outcome of tightness in right and left cheeks and under eyes and red throat was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: Weird feeling; Heart rate increased (fast, about 110); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 28Feb2021 16:15 (Lot number: En6202) at the age of 48 years as dose 1, single for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]), from 28Feb2021 16:15 (Batch/Lot number: unknown) to 28Feb2021 16:15 at single dose. Relevant medical history included: "chiaroscuro type I/ extra nerve in the heart that causes extra beats (as believed by cardiologist)" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Past drug history included: Benadryl IV, start date: 2011, reaction(s): "Heart rate increased". The following information was reported: FEELING ABNORMAL (non-serious) with onset 28Feb2021 16:30, outcome "recovered" (2021), described as "Weird feeling"; HEART RATE INCREASED (non-serious) with onset 28Feb2021 16:30, outcome "recovered" (2021), described as "Heart rate increased (fast, about 110)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, heart rate increased. Additional information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result to doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIPD); This spontaneous report received from a patient concerned a 48 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 night of vaccination, the patient experienced the start of injury. On an unspecified date, the patient experienced chronic inflammatory demyelinating polyneuropathy (CIPD) and started infusion treatment. A lot of tests were performed since April trying to find out what had happened. The patient went from doing endurance racing to barely walking from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chronic inflammatory demyelinating polyneuropathy (cipd) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20220130648 -Covid-19 vaccine ad26.cov2.s- Chronic inflammatory demyelinating polyneuropathy (cipd). This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchoscopy normal, Computerised tomogram thorax abnormal, Culture negative, Organising pneumonia, Pulmonary embolism
Clinical narrative: Massive pulmonary embolism several weeks after second dose of vaccine.  Pt also had organizing pneumonia after booster dosage
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: Massive pulmonary embolism several weeks after second dose of vaccine.  Pt also had organizing pneumonia after booster dosage
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrophy, COVID-19, Cerebral ischaemia, Computerised tomogram head abnormal
Clinical narrative: pt brought to rehab center after hospitalization from a fall; diffuse weakness, chronic ischemic changes on CT with atrophy; diagnosed positive for COVID in rehab center; placed in isolation; treated with vitamins, ASA, antibiotics, decadron; no SOB or s/s acute distress noted in the beginning; developed dry cough then productive cough and fever; became hypotensive, tachycardia, and O2 sats at 79% on RA; placed on O2 via face mask; DNR; pt's condition worsened and he died in the rehab center
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Death, Fall, Hypotension, Productive cough
Clinical narrative: pt brought to rehab center after hospitalization from a fall; diffuse weakness, chronic ischemic changes on CT with atrophy; diagnosed positive for COVID in rehab center; placed in isolation; treated with vitamins, ASA, antibiotics, decadron; no SOB or s/s acute distress noted in the beginning; developed dry cough then productive cough and fever; became hypotensive, tachycardia, and O2 sats at 79% on RA; placed on O2 via face mask; DNR; pt's condition worsened and he died in the rehab center
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: pt brought to rehab center after hospitalization from a fall; diffuse weakness, chronic ischemic changes on CT with atrophy; diagnosed positive for COVID in rehab center; placed in isolation; treated with vitamins, ASA, antibiotics, decadron; no SOB or s/s acute distress noted in the beginning; developed dry cough then productive cough and fever; became hypotensive, tachycardia, and O2 sats at 79% on RA; placed on O2 via face mask; DNR; pt's condition worsened and he died in the rehab center
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Death, Dyspnoea, Encephalopathy, General physical health deterioration
Clinical narrative: EMS reports O2 sats at 82% on RA; pt c/o SOB; brought to ED and placed on BiPAP; eventually transitioned to O2 via NC; treated with decadron and antibiotics; encephalopathy; pt's condition deteriorated; hypotensive and bradycardic; DNR/DNI; pt died in the hosp
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Positive airway pressure therapy
Clinical narrative: EMS reports O2 sats at 82% on RA; pt c/o SOB; brought to ED and placed on BiPAP; eventually transitioned to O2 via NC; treated with decadron and antibiotics; encephalopathy; pt's condition deteriorated; hypotensive and bradycardic; DNR/DNI; pt died in the hosp
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, SARS-CoV-2 test positive
Clinical narrative: 87 y/o male, BMI 26, PMHx quadruple bypass and CKD, admitted for chest pain on 9/24/21. Pt tested positive for Covid in previous admission to a different hospital and was treated with Decadron and antibiotics. Pt has no complaints regarding Covid during this admission. Pt was cleared with cardiology and discharged back to skilled nursing facility on 9/25/21.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Exhausted for a couple of weeks afterward each shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 16:00 (Lot number: Er2613) at the age of 49 years as dose 2, single and administration date 18Mar2021 09:00 (Lot number: Er2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Apr2021), described as "Exhausted for a couple of weeks afterward each shot". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.