chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: pt request we report her adverse event on 8/10/22  @ 4:20pm from her second Shingrix vaccination administered on 12/31/21.  Patient states her sore arm is continuing and evolved into limited movement.  She states she has no pain but constant limited movement of her left arm.  She struggles to put on her bra. She is unable to do arm circles behind her with the left arm. She is unable to reach behind her lower back and around to the right side of her body.  She states the limited movement is horrible.  She does have pain in the left arm if she moves it suddenly behind her body for any reason.  She notified her PCP and she will refer her to a neurologist.  She states she has been having numbness in her left thigh for over 5 years.  She is also having tingling back & forth between both feet once every 3 to 4 days. She attributes the left arm soreness and limitation to the second dose of Shingrix. I requested she keep us posted 8/10/22 4:20pm
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: pt request we report her adverse event on 8/10/22  @ 4:20pm from her second Shingrix vaccination administered on 12/31/21.  Patient states her sore arm is continuing and evolved into limited movement.  She states she has no pain but constant limited movement of her left arm.  She struggles to put on her bra. She is unable to do arm circles behind her with the left arm. She is unable to reach behind her lower back and around to the right side of her body.  She states the limited movement is horrible.  She does have pain in the left arm if she moves it suddenly behind her body for any reason.  She notified her PCP and she will refer her to a neurologist.  She states she has been having numbness in her left thigh for over 5 years.  She is also having tingling back & forth between both feet once every 3 to 4 days. She attributes the left arm soreness and limitation to the second dose of Shingrix. I requested she keep us posted 8/10/22 4:20pm
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Vision blurred
Clinical narrative: Burning and blurry vision within one hour; continuing 5 days later.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Unilateral left eyelid swelling, started approx 22 hours after vaccination
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Behaviour disorder, Blood test normal, Cardiac disorder, Chiropractic, Dysgraphia
Clinical narrative: Short-term I was just wiped out. Over the long-term, I've been having heart issues. They've just been increasing over time, and it's gotten to the point that it's becoming unbearable. My heart feels like it's going to explode. It's like each time it pumps, it shakes my whole body. I have extremely poor blood flow and severe Raynauds.  I started getting tremors in my hand shortly after my booster (Pfizer) in November 2021. The tremors spread to my knees and then to my stomach. It feels like my internal organs are vibrating. It's the worst when I lay down for bed at night. I don't know if it's a combination of both, or if it was J&J or Pfizer. I just want my hands to stop shaking. I'm 25 and can no longer write. Exercise was my life and I can no longer run due to my heart. I had a psychotic episode in June of 2021, I don't know if that's related, but I never had these before. I feel like I've had significant personality changes and behavioral problems since taking it. My whole body hurts, especially my spine and neck. I tried a chiropractor, but it didn't really help. My hands and feet are always white/purple.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Neck pain, Pain, Personality change
Clinical narrative: Short-term I was just wiped out. Over the long-term, I've been having heart issues. They've just been increasing over time, and it's gotten to the point that it's becoming unbearable. My heart feels like it's going to explode. It's like each time it pumps, it shakes my whole body. I have extremely poor blood flow and severe Raynauds.  I started getting tremors in my hand shortly after my booster (Pfizer) in November 2021. The tremors spread to my knees and then to my stomach. It feels like my internal organs are vibrating. It's the worst when I lay down for bed at night. I don't know if it's a combination of both, or if it was J&J or Pfizer. I just want my hands to stop shaking. I'm 25 and can no longer write. Exercise was my life and I can no longer run due to my heart. I had a psychotic episode in June of 2021, I don't know if that's related, but I never had these before. I feel like I've had significant personality changes and behavioral problems since taking it. My whole body hurts, especially my spine and neck. I tried a chiropractor, but it didn't really help. My hands and feet are always white/purple.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Poor peripheral circulation, Psychotic disorder, Raynaud's phenomenon, Skin discolouration, Spinal pain
Clinical narrative: Short-term I was just wiped out. Over the long-term, I've been having heart issues. They've just been increasing over time, and it's gotten to the point that it's becoming unbearable. My heart feels like it's going to explode. It's like each time it pumps, it shakes my whole body. I have extremely poor blood flow and severe Raynauds.  I started getting tremors in my hand shortly after my booster (Pfizer) in November 2021. The tremors spread to my knees and then to my stomach. It feels like my internal organs are vibrating. It's the worst when I lay down for bed at night. I don't know if it's a combination of both, or if it was J&J or Pfizer. I just want my hands to stop shaking. I'm 25 and can no longer write. Exercise was my life and I can no longer run due to my heart. I had a psychotic episode in June of 2021, I don't know if that's related, but I never had these before. I feel like I've had significant personality changes and behavioral problems since taking it. My whole body hurts, especially my spine and neck. I tried a chiropractor, but it didn't really help. My hands and feet are always white/purple.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vibratory sense increased
Clinical narrative: Short-term I was just wiped out. Over the long-term, I've been having heart issues. They've just been increasing over time, and it's gotten to the point that it's becoming unbearable. My heart feels like it's going to explode. It's like each time it pumps, it shakes my whole body. I have extremely poor blood flow and severe Raynauds.  I started getting tremors in my hand shortly after my booster (Pfizer) in November 2021. The tremors spread to my knees and then to my stomach. It feels like my internal organs are vibrating. It's the worst when I lay down for bed at night. I don't know if it's a combination of both, or if it was J&J or Pfizer. I just want my hands to stop shaking. I'm 25 and can no longer write. Exercise was my life and I can no longer run due to my heart. I had a psychotic episode in June of 2021, I don't know if that's related, but I never had these before. I feel like I've had significant personality changes and behavioral problems since taking it. My whole body hurts, especially my spine and neck. I tried a chiropractor, but it didn't really help. My hands and feet are always white/purple.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac discomfort, Condition aggravated, Exercise tolerance decreased, Feeling abnormal
Clinical narrative: I also made a report for my first vaccine (J&J). The problems started with that vaccination, but they began to accelerate a lot faster after getting this booster. Increase in tremor strength, and faster spread. More pressure on my heart. Raynaud's worsened. I can no longer write. I can't exercise anymore, because my heart feels like it's going to explode. At all hours of the day, it feels like my internal organs are vibrating. I don't know if it's a coincidence, and it was caused by my J&J vaccine, and Pfizer booster has nothing to do with this or not. I just thought I'd send in information about this stuff. I've been wanting to for a while, but I don't know. I haven't been able to find any information about people who have mixed J&J with Pfizer.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Raynaud's phenomenon, Tremor
Clinical narrative: I also made a report for my first vaccine (J&J). The problems started with that vaccination, but they began to accelerate a lot faster after getting this booster. Increase in tremor strength, and faster spread. More pressure on my heart. Raynaud's worsened. I can no longer write. I can't exercise anymore, because my heart feels like it's going to explode. At all hours of the day, it feels like my internal organs are vibrating. I don't know if it's a coincidence, and it was caused by my J&J vaccine, and Pfizer booster has nothing to do with this or not. I just thought I'd send in information about this stuff. I've been wanting to for a while, but I don't know. I haven't been able to find any information about people who have mixed J&J with Pfizer.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Hypersomnia, Mobility decreased, Muscle spasticity
Clinical narrative: IN FEW HOURS AFTER INJECTION HAD BLURRED VISION. NEXT MORNING COULD NOT LIFT LEGS, COULD NOT GET OUT OF BED FOR SEVEREAL MINUTES. WHEN SHE WAS ABLE TO SCOOT HERSELF OVER, LEGS WERE SPASTIC. SHE HAD GREAT DIFFICULTY WALKING. ACCORDING TO HER, SHE WAS TOTALLY INCOMPTETENT. THE ARM WAS VERY SORE. SYMPTOMS LASTES FOR 4 HOURS. SHE HAD FEVER&CHILS ABOUT ALL DAY. SHE SLEP ALL DAY. FEVER LASTED ON THE SECON DAY ALSO. SHE CAME TO THE PHARMACY TO RECORD THIS IN IN AUGUST 05/2022
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: IN FEW HOURS AFTER INJECTION HAD BLURRED VISION. NEXT MORNING COULD NOT LIFT LEGS, COULD NOT GET OUT OF BED FOR SEVEREAL MINUTES. WHEN SHE WAS ABLE TO SCOOT HERSELF OVER, LEGS WERE SPASTIC. SHE HAD GREAT DIFFICULTY WALKING. ACCORDING TO HER, SHE WAS TOTALLY INCOMPTETENT. THE ARM WAS VERY SORE. SYMPTOMS LASTES FOR 4 HOURS. SHE HAD FEVER&CHILS ABOUT ALL DAY. SHE SLEP ALL DAY. FEVER LASTED ON THE SECON DAY ALSO. SHE CAME TO THE PHARMACY TO RECORD THIS IN IN AUGUST 05/2022
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: 104 fever, throwing up, body aches, chills
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site pain, Muscle spasms, Pain
Clinical narrative: Significant pain at injection site that radiates. Feels like an intense muscle cramp. Unable to put hand behind head without intense pain.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Biopsy cervix, Dysmenorrhoea, Fatigue, Headache
Clinical narrative: Womens health changes I had had an IUD for 1.5 years NO complications until the vaccine. A month after 11/21 until today 08/22 Every MONTH I now experience Menstrual bleeding  1-2 weeks long, blood clots from pin needle to nickle size, (MIND YOU, I HAVE AN IUD) uterine tissue shedding and globules, immense pelvic pain, back pain, headaches and fatigue. I NEVER EVER HAD THESE ISSUES PRIOR TO. I had Nexplanon for 5 years before the IUD and NEVER had a period or any cramping, clots etc. i have seen a OBGYN almost every other month due to complications and changes to my menstruation,  reproductive health and hormonal imbalances! I had to try a oral pill along WITH the IUD to help the bleeding but had to stop because it caused high blood pressure from too must estrogen. This is TERRIBLE!
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hormone level abnormal, Hypertension, Intra-uterine contraceptive device removal, Pelvic pain
Clinical narrative: Womens health changes I had had an IUD for 1.5 years NO complications until the vaccine. A month after 11/21 until today 08/22 Every MONTH I now experience Menstrual bleeding  1-2 weeks long, blood clots from pin needle to nickle size, (MIND YOU, I HAVE AN IUD) uterine tissue shedding and globules, immense pelvic pain, back pain, headaches and fatigue. I NEVER EVER HAD THESE ISSUES PRIOR TO. I had Nexplanon for 5 years before the IUD and NEVER had a period or any cramping, clots etc. i have seen a OBGYN almost every other month due to complications and changes to my menstruation,  reproductive health and hormonal imbalances! I had to try a oral pill along WITH the IUD to help the bleeding but had to stop because it caused high blood pressure from too must estrogen. This is TERRIBLE!
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Smear cervix, Thrombosis, Ultrasound abdomen
Clinical narrative: Womens health changes I had had an IUD for 1.5 years NO complications until the vaccine. A month after 11/21 until today 08/22 Every MONTH I now experience Menstrual bleeding  1-2 weeks long, blood clots from pin needle to nickle size, (MIND YOU, I HAVE AN IUD) uterine tissue shedding and globules, immense pelvic pain, back pain, headaches and fatigue. I NEVER EVER HAD THESE ISSUES PRIOR TO. I had Nexplanon for 5 years before the IUD and NEVER had a period or any cramping, clots etc. i have seen a OBGYN almost every other month due to complications and changes to my menstruation,  reproductive health and hormonal imbalances! I had to try a oral pill along WITH the IUD to help the bleeding but had to stop because it caused high blood pressure from too must estrogen. This is TERRIBLE!
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Developed significant area of erythema on right anterior medial thigh, swelling 3  weeks after vaccine, warmth, tenderness, spanning about 3 inches  with raised dry center. Developed blisters near area of erythema one day after being seen in office. Placed on oral Keflex.  Resolved by 5 days with oral antibiotics.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Developed significant area of erythema on right anterior medial thigh, swelling 3  weeks after vaccine, warmth, tenderness, spanning about 3 inches  with raised dry center. Developed blisters near area of erythema one day after being seen in office. Placed on oral Keflex.  Resolved by 5 days with oral antibiotics.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Biopsy, Blood test, Computerised tomogram, Disturbance in attention
Clinical narrative: The day after I received the shot, I had an extremely high fever and a migraine. The migraine hasn't gone away. I have chronic swelling on both cheek bones. The swelling in conjunction with the headaches has made it difficult for me to focus and sometimes results in blurred vision. After I received the second shot in the series, I also had adverse effects, but those dissipated. I see my primary doctor regularly. He's referred me to an ENT and a neurologist- I have seen both and have had multiple appointments with the neurologist. Unfortunately, I am still suffering each day.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endoscopy, Headache, Magnetic resonance imaging, Migraine, Pyrexia
Clinical narrative: The day after I received the shot, I had an extremely high fever and a migraine. The migraine hasn't gone away. I have chronic swelling on both cheek bones. The swelling in conjunction with the headaches has made it difficult for me to focus and sometimes results in blurred vision. After I received the second shot in the series, I also had adverse effects, but those dissipated. I see my primary doctor regularly. He's referred me to an ENT and a neurologist- I have seen both and have had multiple appointments with the neurologist. Unfortunately, I am still suffering each day.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Vision blurred, X-ray dental
Clinical narrative: The day after I received the shot, I had an extremely high fever and a migraine. The migraine hasn't gone away. I have chronic swelling on both cheek bones. The swelling in conjunction with the headaches has made it difficult for me to focus and sometimes results in blurred vision. After I received the second shot in the series, I also had adverse effects, but those dissipated. I see my primary doctor regularly. He's referred me to an ENT and a neurologist- I have seen both and have had multiple appointments with the neurologist. Unfortunately, I am still suffering each day.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, New daily persistent headache
Clinical narrative: The day after I received the shot, I had an extremely high fever and a migraine. The migraine hasn't gone away. I have chronic swelling on both cheek bones. The swelling in conjunction with the headaches has made it difficult for me to focus and sometimes results in blurred vision. After I received the second shot in the series, I also had adverse effects, but those dissipated. I see my primary doctor regularly. He's referred me to an ENT and a neurologist- I have seen both and have had multiple appointments with the neurologist. Unfortunately, I am still suffering each day.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pain + redness localized to the injection site (normal level after an injection) started immediately The day after the injection, the area under it started to get a little hard (about 2/3 of an inch across, and 1/2 an inch deep. On day 7, the red area began receding, and is only slightly warmer than the surrounding skin. The lump under the injection site remains, but is less tender.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site warmth
Clinical narrative: Pain + redness localized to the injection site (normal level after an injection) started immediately The day after the injection, the area under it started to get a little hard (about 2/3 of an inch across, and 1/2 an inch deep. On day 7, the red area began receding, and is only slightly warmer than the surrounding skin. The lump under the injection site remains, but is less tender.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Biopsy
Clinical narrative: Total hair loss more than 70% including body hair .diagnosed as  AA after head biopsy
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia, Pruritus
Clinical narrative: Patient received Pfizer COVID vaccine at clinic. About 15 minutes afterward developed swelling of right eye and whole body itchiness. Was given benadryl about 30-45 min after vaccine dose for these symptoms. She was then observed at the clinic. Epi given at about 1753 and patient was subsequently brought to Emergency department for further management. No breathing issues. No swelling of lips, tongue, mouth. No rash noted on body. No vomiting. Patient is otherwise healthy. Takes no medications. No food allergies or other known allergies. No recent fevers, rhinorrhea, cough, abdominal pain, dysuria, diarrhea. Patient received lidocaine under arm prior to vaccine injection. Family wondering if she could have touched the lidocaine and then touched her thigh. Had eye redness and itchiness with swelling initially.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood uric acid increased, Condition aggravated, Gait disturbance, Gout
Clinical narrative: Pt stated psoriasis after her 2nd Moderna COVID vaccine in March of 2021. She woke up COVERED in psoriasis. In May/June of 2021, she came down w/psoriatic arthritis so bad, she was bedridden and when she did get up, she was still on a walker and could barely ambulate. Her only complaint now is GOUT. She takes allopurinol 100 mg b.i.d. and colchicine 0.6 mg every other day. She cannot increase the doses b/c of her renal function. Used to have a gout flare about once/year but now she can't get her uric acid level down chronically and can't understand why.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Psoriatic arthropathy, Walking aid user
Clinical narrative: Pt stated psoriasis after her 2nd Moderna COVID vaccine in March of 2021. She woke up COVERED in psoriasis. In May/June of 2021, she came down w/psoriatic arthritis so bad, she was bedridden and when she did get up, she was still on a walker and could barely ambulate. Her only complaint now is GOUT. She takes allopurinol 100 mg b.i.d. and colchicine 0.6 mg every other day. She cannot increase the doses b/c of her renal function. Used to have a gout flare about once/year but now she can't get her uric acid level down chronically and can't understand why.
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Product preparation issue
Clinical narrative: Yellow fever vaccine was reconstituted using the incorrect diluent (sterile water) and administered to patient. Sanofi Pasteur (manufacturer) was consulted and notified.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaemia, Haematocrit decreased, Haemoglobin decreased, Immature granulocyte count increased, Leukopenia
Clinical narrative: anemia Hb12.4 HCT - 37 on 8/4/2022 H/H 11-8/37 on 4/25/2022 immature granulocytes - present on both labs; lymphopenia - 0.6 on 8/4/2022; 0.6 on 4/25/2022 monocytosis - 15% on 8/4/2022;  high RDW - 17.2 on 8/4/2022 leukopenia 3.5K on 8/4/2022
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphocyte count decreased, Lymphopenia, Monocyte percentage increased, Monocytosis, Red cell distribution width increased
Clinical narrative: anemia Hb12.4 HCT - 37 on 8/4/2022 H/H 11-8/37 on 4/25/2022 immature granulocytes - present on both labs; lymphopenia - 0.6 on 8/4/2022; 0.6 on 4/25/2022 monocytosis - 15% on 8/4/2022;  high RDW - 17.2 on 8/4/2022 leukopenia 3.5K on 8/4/2022
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: anemia Hb12.4 HCT - 37 on 8/4/2022 H/H 11-8/37 on 4/25/2022 immature granulocytes - present on both labs; lymphopenia - 0.6 on 8/4/2022; 0.6 on 4/25/2022 monocytosis - 15% on 8/4/2022;  high RDW - 17.2 on 8/4/2022 leukopenia 3.5K on 8/4/2022
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Pain
Clinical narrative: Tested positive for COVID on 03/13-3/22/2022. Symptoms: body aches, headaches, fever 101.3. Persistent cough and fatigue, lasted about 45 days. I visited my physician and was prescribed cough medication. However I only took OTC ROBITUSSIN DM and TYLENOL.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID on 03/13-3/22/2022. Symptoms: body aches, headaches, fever 101.3. Persistent cough and fatigue, lasted about 45 days. I visited my physician and was prescribed cough medication. However I only took OTC ROBITUSSIN DM and TYLENOL.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling cold, Nausea, Pyrexia
Clinical narrative: chills, fever, diarrhea, nausea
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: 1/23/22 pt had a positive COVID test at Medical Center; given IV ABX and steroids; also had Pulmonary Embolus; dc'd to SNF on 1/28/22; comfort care measures only; pt found deceased in nursing home
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: 1/23/22 pt had a positive COVID test at Medical Center; given IV ABX and steroids; also had Pulmonary Embolus; dc'd to SNF on 1/28/22; comfort care measures only; pt found deceased in nursing home
Age: 12.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Nervous system disorder
Clinical narrative: worsening behavior noted since December 2021-- disorganized, depression (more withdrawn), more tired, more anxiety (admitted to mental health inpatient unit from 2/18-2/23). Continues to have work-up completed for change in behavior.
Age: 12.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Abnormal behaviour, Anxiety, CSF test, Culture negative, Depression
Clinical narrative: worsening behavior noted since December 2021-- disorganized, depression (more withdrawn), more tired, more anxiety (admitted to mental health inpatient unit from 2/18-2/23). Continues to have work-up completed for change in behavior.
Age: 12.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Fatigue, Immunology test normal, Metabolic function test normal, Social avoidant behaviour, Toxicologic test
Clinical narrative: worsening behavior noted since December 2021-- disorganized, depression (more withdrawn), more tired, more anxiety (admitted to mental health inpatient unit from 2/18-2/23). Continues to have work-up completed for change in behavior.
Age: 12.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Urine analysis normal
Clinical narrative: worsening behavior noted since December 2021-- disorganized, depression (more withdrawn), more tired, more anxiety (admitted to mental health inpatient unit from 2/18-2/23). Continues to have work-up completed for change in behavior.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Hearing loss; severe tinnitus/severe ringing in the left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid Disease", start date: 01Jan2005, stop date: 17May2017, notes: Radiation Therapy; "Pre Diabetes", start date: 06Jan2018 (ongoing), notes: Metformin Pills Diet/ Exercise; "Booster dose due to a weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired. Vaccination history included: BNT162b2 (Dose: 1st, Date : 11Mar2021, Anatomical site of injection : Left Arm, Batch/Lot Number :# EN6208), administration date: 11Mar2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2nd, Date : 08Apr2021, Anatomical site of injection : Left Arm, Batch/Lot Number : # ER8737), administration date: 08Apr2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3rd, Date : 30Sep2021, Anatomical site of injection : Right Arm, Batch/Lot Number : FF2587), administration date: 30Sep2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (disability, medically significant) with onset 22Apr2022, outcome "not recovered", described as "severe tinnitus/severe ringing in the left ear"; DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "severe tinnitus/severe ringing in the left ear" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (unspecified date) Hearing loss; Computerised tomogram: (12May2022) showed nothing as to damage/cause, notes: Tinnitus Exam; Magnetic resonance imaging: (11May2022) showed nothing as to damage/cause, notes: For ringing /Tinnitus in left ear after Booster; (08Jun2022) Unknown Results, notes: 2nd review for tinnitus in left Ear. Therapeutic measures were taken as a result of tinnitus, deafness.  Additional information: No prior Vaccinations within 4 weeks. Medication in attempt to stop issue.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Deafness, Magnetic resonance imaging, Tinnitus
Clinical narrative: Hearing loss; severe tinnitus/severe ringing in the left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid Disease", start date: 01Jan2005, stop date: 17May2017, notes: Radiation Therapy; "Pre Diabetes", start date: 06Jan2018 (ongoing), notes: Metformin Pills Diet/ Exercise; "Booster dose due to a weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired. Vaccination history included: BNT162b2 (Dose: 1st, Date : 11Mar2021, Anatomical site of injection : Left Arm, Batch/Lot Number :# EN6208), administration date: 11Mar2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2nd, Date : 08Apr2021, Anatomical site of injection : Left Arm, Batch/Lot Number : # ER8737), administration date: 08Apr2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3rd, Date : 30Sep2021, Anatomical site of injection : Right Arm, Batch/Lot Number : FF2587), administration date: 30Sep2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (disability, medically significant) with onset 22Apr2022, outcome "not recovered", described as "severe tinnitus/severe ringing in the left ear"; DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "severe tinnitus/severe ringing in the left ear" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (unspecified date) Hearing loss; Computerised tomogram: (12May2022) showed nothing as to damage/cause, notes: Tinnitus Exam; Magnetic resonance imaging: (11May2022) showed nothing as to damage/cause, notes: For ringing /Tinnitus in left ear after Booster; (08Jun2022) Unknown Results, notes: 2nd review for tinnitus in left Ear. Therapeutic measures were taken as a result of tinnitus, deafness.  Additional information: No prior Vaccinations within 4 weeks. Medication in attempt to stop issue.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Patient admitted with COVID 7/25/22 and continues to be positive in this admission 8/10/22. Symptomatic.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone marrow transplant, COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Patient admitted with COVID 7/25/22 and continues to be positive in this admission 8/10/22. Symptomatic.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: it is strange in your body where it attacks your joints; I haven't been able to work; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 06Aug2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "it is strange in your body where it attacks your joints". Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient has been having problems since the first vaccine. He says he has received them all. He had the two primary doses of the COVID Vaccines and both boosters. The last booster was maybe a month or a month and a half ago maybe he says. He says he is having problems. He thinks it is strange in your body where it attacks your joints. He was asking if there were quite a few people that called on the joint pain and he did not want to read off any information, so he declined to even have it look it up and then he said that he would like, it would be nice if Pfizer would pay for his hyperbaric oxygen treatments (Further not clarified) and he has not been able to work.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were reported.
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were reported.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022).    No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  Patient received half dose. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022).    No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  Patient received half dose. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022.
Age: 12.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022). No concomitant medications were provided by the reporter. Patient received full dose. Vial was initially stored in the refrigerator on 04-Jun-2022. Vaccine administered to 346 patients after the 30 days by used involved 35 vials. Vial did not undergo any temperature excursions. No treatment medications were provided by the reporter.