chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bladder disorder, CSF immunoglobulin G index, Chest injury, Disability
Clinical narrative: Diagnosed with Neuromyelitis Optica. Which in tern triggered Transverse Myelitis.  Hospital treatment; high does of steroids, plasma exchange. Home treatment; high does of Prednisone with eventual taper, I'm still on Prednisone  low dose .many other medication to mange pain and side effect. I was hit below my ribcage. Legs affected, feet affected, abdomen affected, bladder affected, bowel affected. Continuing severe. Ongoing disability.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Laboratory test, Limb discomfort, Myelitis transverse, Neuromyelitis optica spectrum disorder
Clinical narrative: Diagnosed with Neuromyelitis Optica. Which in tern triggered Transverse Myelitis.  Hospital treatment; high does of steroids, plasma exchange. Home treatment; high does of Prednisone with eventual taper, I'm still on Prednisone  low dose .many other medication to mange pain and side effect. I was hit below my ribcage. Legs affected, feet affected, abdomen affected, bladder affected, bowel affected. Continuing severe. Ongoing disability.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Plasmapheresis, Viral titre
Clinical narrative: Diagnosed with Neuromyelitis Optica. Which in tern triggered Transverse Myelitis.  Hospital treatment; high does of steroids, plasma exchange. Home treatment; high does of Prednisone with eventual taper, I'm still on Prednisone  low dose .many other medication to mange pain and side effect. I was hit below my ribcage. Legs affected, feet affected, abdomen affected, bladder affected, bowel affected. Continuing severe. Ongoing disability.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Janssen vaccine given to 17 year old.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After first dose arm was sore for about 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 13:30 (Lot number: EL9266) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Peanuts" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; TOPAMAX; VITAMIN D [VITAMIN D NOS]; BUPROPION; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Feb2021 12:00, outcome "recovered" (24Feb2021), described as "After first dose arm was sore for about 24 hours". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.  Additional information: After first dose arm was sore for about 24 hours. After second dose, 12 hours after shot woke up in the middle of the night with fever, chills, and muscle aches. Took Advil to take fever down and went back to sleep. Woke up 6 hours later with same symptoms, took another Advil, symptoms went away and did not return. The patient did not have covid 19 prior vaccination. The patient tested negative for covid 19 post vaccination. The patient tested for surgery on 10Mar2021 by nasal swab. The patient not received any other vaccine in four weeks.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Neck pain
Clinical narrative: Neck pain flared up really bad after the booster dose/Pain is on both sides of her neck but more on the right side./Pain on her neck is extremely excoriating; Bed ridden; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain flared up really bad after the booster dose/Pain is on both sides of her neck but more on the right side./Pain on her neck is extremely excoriating) and BEDRIDDEN (Bed ridden) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 024M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain flared up really bad after the booster dose/Pain is on both sides of her neck but more on the right side./Pain on her neck is extremely excoriating) and BEDRIDDEN (Bed ridden). The patient was treated with CEFIXIME (FLEXERIL [CEFIXIME]) at a dose of 10 milligram and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain flared up really bad after the booster dose/Pain is on both sides of her neck but more on the right side./Pain on her neck is extremely excoriating) and BEDRIDDEN (Bed ridden) had not resolved.            It was reported that the doctor gave patient a trigger point injection. She also had to get a massage every day to function because the pain was very bad, massage was done from every day since February. Patient was still experiencing the side effects.   This case was linked to MOD-2022-454652, MOD-2022-454758.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nerve damage, Injection site pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient claims still has pain at the injection site til this date. pain radiates down to forearm that affects motor control. no numbness. this is only in the left arm where the vaccine was injected. patient spoke with Dr. and suspects a nerve was hit at injection site.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Medial tibial stress syndrome, Myalgia, Pain in extremity
Clinical narrative: Booster; Severe leg & back pain; Severe leg & back pain; Shin splints; tender muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Growing pains" (unspecified if ongoing), notes: Almost like growing pains from when I was a child. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2), for COVID-19 immunization; Bnt162b2 (Dose:1), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "recovered" (2021) and all described as "Severe leg & back pain"; MEDIAL TIBIAL STRESS SYNDROME (non-serious), outcome "recovered" (2021), described as "Shin splints"; MYALGIA (non-serious), outcome "recovered" (2021), described as "tender muscles".  Additional information: Severe leg & back pain after booster - lasting over a week. Almost like growing pains from when the patient was a child. Shin splints and super tender muscles. After second dose patient had to attend physical therapy.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101878260 Same patient, same drug, different dose
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Paraesthesia, Swelling
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 10:30 (Lot number: FJ1611) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 35 years old, for COVID-19 Immunization.The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 10:30, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 28Dec2021 06:00, outcome "recovering", described as "Swollen lymph node in armpit on side of injection day after"; PARAESTHESIA (non-serious) with onset 28Dec2021 06:00, outcome "recovering", described as "Some tingling in left hand fingers at end of day"; SWELLING (non-serious) with onset 28Dec2021 06:00, outcome "recovering", described as "Swelling has increased throughout the day". Therapeutic measures were not taken as a result of lymphadenopathy, paraesthesia, swelling.Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not took any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no.No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Hives full body; Dermatographism full body; Itching full body; Redness full body; Rash full body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included ISOTRETINOIN and EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In 2021, the patient experienced URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body). At the time of the report, URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-437106, MOD-2021-437129 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Rash, Urticaria
Clinical narrative: Hives full body; Dermatographism full body; Itching full body; Redness full body; Rash full body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included ISOTRETINOIN and EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In 2021, the patient experienced URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body). At the time of the report, URTICARIA (Hives full body), MECHANICAL URTICARIA (Dermatographism full body), PRURITUS (Itching full body), ERYTHEMA (Redness full body) and RASH (Rash full body) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-437106, MOD-2021-437129 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Intensive care, Pulmonary embolism
Clinical narrative: Patient developed an unprovoked pulmonary embolism after receiving her COVID 19 booster.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Patient developed an unprovoked pulmonary embolism after receiving her COVID 19 booster.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: arm was a bit sore; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EN6198), for COVID-19 IMMUNISATION. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "dizziness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was a bit sore". No follow-up attempts are possible. No further information is expected.  Additional information: Patient wanted to know if dizziness was common and how long it lasts.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: arm was a bit sore; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EN6198), for COVID-19 IMMUNISATION. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "dizziness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was a bit sore". No follow-up attempts are possible. No further information is expected.  Additional information: Patient wanted to know if dizziness was common and how long it lasts.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Patient called on Wednesday 01/19/2022 and informed me that she has a lump under her left armpit, she noticed it on Tuesday(1/18/2022). Patient had gotten the Pfizer vaccine booster on Sunday 01/16/2022 and per patient she thinks it is from the vaccine. However, patient said the lump is less tender compared to yesterday (Tuesday, 01/18/2022); patient said she will reach out to her doctor if it doesn't get better. Advised patient to get it examined with her doctor.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diplegia, Dysphagia, Inappropriate schedule of product administration, Muscle spasticity, Paralysis
Clinical narrative: Paralysis and spasticity of legs. Paralysis of hands. Inability to swallow. All occurred within 48 hours of injection.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 103-104 degrees for 36 hours
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mechanical urticaria, Pruritus
Clinical narrative: Booster/3rd dose of Moderna vaccine caused dermographic urticaria that the first two doses did not cause. Symptoms developed on 1/15/2022 with itchy scalp.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given 0.25ml instead of 0.5ml for second dose.  Pt was contacted on 01/15/2022 and offered another dose of 0.25ml. He declined.  He was told that due to the lesser dose he did not complete the series to be considered fully vaccinated.  He still did not want.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Ear discomfort, Ear pain, Magnetic resonance imaging normal
Clinical narrative: Ears plugged up (just one, according to hearing test done?) Stayed plugged for a couple weeks. Occasional right ear pain. Steroid pills for 10 days cleared it up, but plugging came right back within a day after treatment ended. MRI was normal. Only thing keeping hearing loss at bay seems to be antihistamine with decongestant taken constantly. Even so, can hear/feel ears continuing to try to plug up again. On and off tinnitus entire time other than when on steroids. This has now been going on for over a month, and only other treatment offered by dr. is steroid injected into ear drum.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears plugged up (just one, according to hearing test done?) Stayed plugged for a couple weeks. Occasional right ear pain. Steroid pills for 10 days cleared it up, but plugging came right back within a day after treatment ended. MRI was normal. Only thing keeping hearing loss at bay seems to be antihistamine with decongestant taken constantly. Even so, can hear/feel ears continuing to try to plug up again. On and off tinnitus entire time other than when on steroids. This has now been going on for over a month, and only other treatment offered by dr. is steroid injected into ear drum.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Myalgia, Somnolence
Clinical narrative: I felt fluish first day after last shot and had muscle soreness, but now I am unable to sleep/don't want to sleep. This is very unusual for me. I take medication for depression/anxiety, and trazodone when needed to sleep at night if I'm feeling restless. I've usually had a problem with feeling sleepy during the day. I feel wired for no reason. I don't drink caffeine, I do smoke, but this is like I don't even want to go to sleep. This is not normal for me. Please help.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives, full body rash, 2 weeks+ Treatment with zyrtec
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood creatine phosphokinase, Blood lactate dehydrogenase, Fatigue
Clinical narrative: Day of injection-Mild soreness in left arm Day 2-Moderate-Severe pain at site of injection that continued for 5 plus days Day 5- Leg weakness/fatigue to present day ( fatigued, deep aching pain like to the bone, pain in multiple locations including front and back of thighs in each leg, pain in calves, sharp stabbing, shooting, and pinching pains in legs. Legs hurt all day even affecting  sleep, hurts if sitting or walking but walking/ exercising appears to fatigue them exponentially. Severe pain in upper middle part of back behind heart past 2 weeks. Also having bilateral shoulder pain and arm fatigue bilaterally as well. Hip/Buttock pain since day 5.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Glomerular filtration rate, Injection site pain, Laboratory test, Metabolic function test
Clinical narrative: Day of injection-Mild soreness in left arm Day 2-Moderate-Severe pain at site of injection that continued for 5 plus days Day 5- Leg weakness/fatigue to present day ( fatigued, deep aching pain like to the bone, pain in multiple locations including front and back of thighs in each leg, pain in calves, sharp stabbing, shooting, and pinching pains in legs. Legs hurt all day even affecting  sleep, hurts if sitting or walking but walking/ exercising appears to fatigue them exponentially. Severe pain in upper middle part of back behind heart past 2 weeks. Also having bilateral shoulder pain and arm fatigue bilaterally as well. Hip/Buttock pain since day 5.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal pain, Pain, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Day of injection-Mild soreness in left arm Day 2-Moderate-Severe pain at site of injection that continued for 5 plus days Day 5- Leg weakness/fatigue to present day ( fatigued, deep aching pain like to the bone, pain in multiple locations including front and back of thighs in each leg, pain in calves, sharp stabbing, shooting, and pinching pains in legs. Legs hurt all day even affecting  sleep, hurts if sitting or walking but walking/ exercising appears to fatigue them exponentially. Severe pain in upper middle part of back behind heart past 2 weeks. Also having bilateral shoulder pain and arm fatigue bilaterally as well. Hip/Buttock pain since day 5.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Day of injection-Mild soreness in left arm Day 2-Moderate-Severe pain at site of injection that continued for 5 plus days Day 5- Leg weakness/fatigue to present day ( fatigued, deep aching pain like to the bone, pain in multiple locations including front and back of thighs in each leg, pain in calves, sharp stabbing, shooting, and pinching pains in legs. Legs hurt all day even affecting  sleep, hurts if sitting or walking but walking/ exercising appears to fatigue them exponentially. Severe pain in upper middle part of back behind heart past 2 weeks. Also having bilateral shoulder pain and arm fatigue bilaterally as well. Hip/Buttock pain since day 5.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Client reports with both 1st and 2nd Pfizer COVID vaccine she developed numbness in both legs with onset at 6-8 hours post vaccination and lasting throughout the night.  Resolved without intervention, did not follow up with primary care provider.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Heart rate increased, Mechanical urticaria, Palpitations
Clinical narrative: Starting experiencing hives and itchiness all over my body 11 days after booster shot moderna. Took prednisone for 10 days and steroid ointment cream. Did not help. Later took antibiotics Macrobid for a urinary tract infection. Hives still persisted after uti went away. also started experiencing increased heart palpitations and increased heart rate around Dec. 13. Started taking antihistamines hydroxyzine and Pepcid. Both have decreased the symptoms of itchiness and hives and dermatographia. However they do return if I stop taking medication. Now I am experiencing increased chest pain and tightness on January 18. I?ve been taking Zyrtec and pepcid consistently for two weeks since January 6. Dermatographia returns if I miss an antihistamine dosage. Heart palpitations still present. Chest pain is new.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Symptom recurrence, Urinary tract infection, Urticaria
Clinical narrative: Starting experiencing hives and itchiness all over my body 11 days after booster shot moderna. Took prednisone for 10 days and steroid ointment cream. Did not help. Later took antibiotics Macrobid for a urinary tract infection. Hives still persisted after uti went away. also started experiencing increased heart palpitations and increased heart rate around Dec. 13. Started taking antihistamines hydroxyzine and Pepcid. Both have decreased the symptoms of itchiness and hives and dermatographia. However they do return if I stop taking medication. Now I am experiencing increased chest pain and tightness on January 18. I?ve been taking Zyrtec and pepcid consistently for two weeks since January 6. Dermatographia returns if I miss an antihistamine dosage. Heart palpitations still present. Chest pain is new.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Thrombosis
Clinical narrative: Menstrual cycle is no longer consistent. I was always 28 days; however, now it is 30+ days up to 38 days. My periods have become very heavy, large clots and last over a week and then another week  sporadic of spotting. My cycle is inconsistent and no longer normal from what I am used to.  My periods have increased in pain and I will have surges of pain in my ovaries.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic enzyme increased
Clinical narrative: Elevated AST and ALT liver enzymes.  Doctor is just monitoring.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Elevated AST and ALT
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: elevated AST and ALT
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears. Especially noticeable when sitting in a quiet room. Constant low ring when reading or focusing. I'm talking louder at people and it is noticeable to others.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Mechanical urticaria, Menstrual disorder, Pruritus, Rash erythematous
Clinical narrative: Spontaneous Urticaria- Severe random itching of the skin. Arms, legs, feet, chest, neck, back. When scratched, small red bumps appear as well as dermatographia. Resistant to anti-itch creams. Menstrual period was also 2 days late with 3 days of cramps before the period started, which is unusual for me. It also only lasted 3 days, when it is normally 5.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Spontaneous Urticaria- Severe random itching of the skin. Arms, legs, feet, chest, neck, back. When scratched, small red bumps appear as well as dermatographia. Resistant to anti-itch creams. Menstrual period was also 2 days late with 3 days of cramps before the period started, which is unusual for me. It also only lasted 3 days, when it is normally 5.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Palpitations, Troponin increased
Clinical narrative: chest pain palpitations
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myocarditis
Clinical narrative: chest pain palpitations
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Sinus tachycardia, Troponin I increased, Vaccination complication
Clinical narrative: chest pain palpitations
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Covid Vaccination on 14 March at 2:45 pm, left arm. Itch began 22 March evening (11:00 pm) at injection site. Swelling 23 March morning at injection site. Redness 24 March morning at injection site. Swelling and redness spread over next several days, then cleared over subsequent days.  Pacemaker on that side.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Hard lump the diameter of a golf ball (feels disc shaped) developed at injection site. Pain, heat, redness and moderate itching present. Small rash in a circle approximately the same size of the lump is also present.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Hard lump the diameter of a golf ball (feels disc shaped) developed at injection site. Pain, heat, redness and moderate itching present. Small rash in a circle approximately the same size of the lump is also present.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol intolerance
Clinical narrative: Got drunk easily.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed and erratic menstrual cycle
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: urticaria and angioedema of the palms of hands.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: one dose of VARIVAX was improperly stored on 12/28/2021 and administered to one patient on the same day; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 28-DEC-2021, the patient started therapy with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number T032322 expiration date 22-SEP-2022 (Dosage regimen and route of administration were not provided) prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 6.4 degree fahrenheit (°F) for 2 hours 30 minutes on 28-DEC-2021; no previous temperature excursions were reported.; Sender's Comments:  US-009507513-2201USA000559:
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased
Clinical narrative: She had 104 temperature; Information has been received from a female patient of unknown age via Pfizer concerning herself. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On an unknown date, the patient had a 104 degrees temperature (body temperature abnormal). The outcome of the event was unknown.  Causal relationship between hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and body temperature abnormal was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: no additional AEs were provided; an expired PROQUAD (12/21/2021) was given to a patient on 12/29/2021; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 29-DEC-2021, the patient was vaccinated with expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) 1 dose for prophylaxis (lot# T021643, expiration date 21-DEC-2021; strength and route were not reported) (expired product administered). No additional adverse events (AEs) or further information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs; Vaccine administered after temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 19-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter, lot number U019286, expiration date: 15-DEC-2022, administered subcutaneously as prophylaxis (strength and frequency were not provided). It was reported that the vaccine had experienced a temperature excursion (product storage error), for 8 hours and 5 minutes at 6.8 degrees Fahrenheit, no previous temperature excursions were reported. No additional events were reported. At the time of reporting, the outcome of the event was not known.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, the pt suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) vaccine, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the events herpes zoster and postherpetic neuralgia to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shot, and still had outbreaks, shingles/ Suspected vaccination failure; still had outbreaks, shingles; extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported he/she had shingles, got the shot and still had outbreaks. The patient takes oral medication daily for it now. The patient stated it was extremely painful and you were at higher risk if you have had chicken pox. The patient said get that shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had two shots, my daughter and I had it at the same time/ Suspected Vaccination failure; my daughter and I had it at the same time; Pain was unbelievable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient got both the Shingles shots and still got shingles. The reporter stated that the pain was unbelievable. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case had been linked with US2022AMR009082, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR009082:same reporter, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Illness, Influenza like illness, Mobility decreased, Pain
Clinical narrative: reactions similar to the flu; chills; soreness; feel sick; Couldn't raise arm; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of influenza like illness (received first dose on an unknown date and experienced Influenza-like symptoms, chills, soreness, mobility decreased and sickness, refer case US2022AMR009104).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms, chills, pain, mobility decreased and sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms, chills, pain and sickness were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, pain, mobility decreased and sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR009104.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had reactions to the shingles shot similar to the flu, chills and soreness.  Could not raise his/ her arm for a week.  Still got the second shot and same thing happened.  The patient figured it was better to feel sick than to deal with shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR009104:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th January 2022, the patient received the 2nd dose of Shingles vaccine. On 15th January 2022, less than a day after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported he/she had the second shot the morning of the day of reporting and wanted to know if he/she should use heat or ice for the pain. The follow-up would not be possible as no contact details were available.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling sensation along his spine; This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles in the past).   On 13th January 2022, the patient received the 2nd dose of Shingrix. On 13th January 2022, less than a day after receiving Shingrix, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was not recovered/not resolved.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's daughter.  The reporter called in to report that the patient received Shingrix day before reporting and later that same evening he reported feeling a tingling sensation along his spine which had not resolved.  The reporter asked if that was a common adverse reaction, spoke on common side effects.  The reporter also noted that the patient had Shingles in the past, advised the clinical trials did not include patients who had a history of shingles.  The reporter refused to provide mailing address and Health care professional information. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, Blood test, Dizziness, Inflammation, Limb mass
Clinical narrative: VEIN IN LEFT LEG/SPIDER VEIN; TINGLING IN LEG; LOW IMMUNITY/ANTIBODIES AGAINST COVID-19; LUMPS IN LEFT LEG THAT POP OUT IN CALF/ANKLE; SWELLING IN THE ANKLE AND CALF; INFLAMMATION; DIZZY; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: tumor on meninges/benign brain tumor, leg pain, tinnitus, and anxiety, and concurrent conditions included: prediabetic, sciatica, loss of taste, and neurological problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination.  On AUG-2021, the patient experienced dizzy. On NOV-2021, the patient experienced lumps in left leg that pop out in calf/ankle, swelling in the ankle and calf, and inflammation. On DEC-2021, the patient experienced low immunity/antibodies against covid-19. Laboratory data included: Blood test (NR: not provided) low immunity. On an unspecified date, the patient experienced vein in left leg/spider vein, and tingling in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lumps in left leg that pop out in calf/ankle, swelling in the ankle and calf, and inflammation on JAN-2022, had not recovered from low immunity/antibodies against covid-19, and the outcome of dizzy, tingling in leg and vein in left leg/spider vein was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000210916. The suspected product quality complaint has been confirmed to be this record indicates medical adverse events for the patient. while the patient reported "low immunity" this report does not state the patient has no antibodies or that the vaccine did not work and does not meet the criteria for lack of efficacy. based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Paraesthesia, Spider vein
Clinical narrative: VEIN IN LEFT LEG/SPIDER VEIN; TINGLING IN LEG; LOW IMMUNITY/ANTIBODIES AGAINST COVID-19; LUMPS IN LEFT LEG THAT POP OUT IN CALF/ANKLE; SWELLING IN THE ANKLE AND CALF; INFLAMMATION; DIZZY; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: tumor on meninges/benign brain tumor, leg pain, tinnitus, and anxiety, and concurrent conditions included: prediabetic, sciatica, loss of taste, and neurological problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination.  On AUG-2021, the patient experienced dizzy. On NOV-2021, the patient experienced lumps in left leg that pop out in calf/ankle, swelling in the ankle and calf, and inflammation. On DEC-2021, the patient experienced low immunity/antibodies against covid-19. Laboratory data included: Blood test (NR: not provided) low immunity. On an unspecified date, the patient experienced vein in left leg/spider vein, and tingling in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lumps in left leg that pop out in calf/ankle, swelling in the ankle and calf, and inflammation on JAN-2022, had not recovered from low immunity/antibodies against covid-19, and the outcome of dizzy, tingling in leg and vein in left leg/spider vein was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000210916. The suspected product quality complaint has been confirmed to be this record indicates medical adverse events for the patient. while the patient reported "low immunity" this report does not state the patient has no antibodies or that the vaccine did not work and does not meet the criteria for lack of efficacy. based on the PQC evaluation/investigation performed.