chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA. Intense pain and range of motion problems began around 1 week after getting the flu shot; I don't remember the exact date at this point. Couldn't really hold or carry anything using my left arm. Even putting on my seatbelt or lifting a glass of water hurt, and with anything much heavier than that, like grocery bags, my arm was too weak and hurt too much to hold it. Pain goes from shoulder front down bicep, until elbow. <more below> Since the pain didn't start immediately after getting the shot, for a long time I assumed it couldn't have really been the shot, even though I suspected it might have been, based on where the pain was. Only after reading about SIRVA the other night (never heard of it before; I was Googling "shoulder pain and vaccines") did I realize that that's almost certainly what this is. Since I was seeing my primary doctor for my annual physical yesterday, I discussed this with her. She did a shoulder exam, and is sending me to get a shoulder x-ray. She agrees that what I've been experiencing sounds exactly like SIRVA, and she instructed me to report it using this system.   When my condition didn't get any better after a month - I kept thinking that whatever it was would fix itself with time - I went to a massage therapist/PT for treatment. Condition improved, but there was still a lot of pain moving/using that arm. I had a second treatment this week and I am better yet, but still nowhere near 100%. I have another treatment scheduled in a few weeks. Not sure how many treatments it's going to take to fully recover, but at least I'm seeing progress. At this point, after everything I've read about SIRVA, and after discussing all this with my doctor, it seems clear that this was almost certainly caused by improper administration of the vaccine. I'm no doctor, but I suspect the shot was given too high on my arm. I wasn't paying much attention at the time - I mean, I've had plenty of vaccinations without any problems - but I do remember thinking that where he gave me the shot seemed a little higher than they usually go. But I didn't really think anything of it, because I had no idea that could be a problem. I feel strongly that this should be investigated. I don't know if the person who administered my vaccine made a single mistake - on me - or if he has injured more people and needs retraining. I just know that I have to do my part to make sure he isn't hurting anyone else. This has had a substantial impact on my quality of life for nearly two months now, and it's not over yet. Thank you.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Incoherent, Panic attack
Clinical narrative: PANIC ATTACK OCCURRED ALMOST IMMEDIATELY FOLLOWING VACCINATION (3RD DOSE IN SERIES). PATIENT BECAME INCOHERENT 3 TIMES WITHIN A SHORT PERIOD OF TIME (MAYBE 15 MINUTES). SHE FELL TO THE GROUND AND THE IMMUNIZER NOTICED IMMEDIATELY AND CALLED FOR HELP/BACK-UP. PHARMACIST ON DUTY IMMEDIATELY ATTENDED TO THE PATIENT, ASSESSED THE SITUATION AND HAD 9-1-1 CALLED. MANAGEMENT ON DUTY WAS ALSO NOTIFIED. LATER, PARENTS INDICATED THAT PREVIOUS 2 SHOTS WERE GIVEN WITHOUT INCIDENT BUT IN FACT SHE HAD PASSED OUT IN THE PAST (POST IMMUNIZATION) FROM PANIC ATTACKS CAUSED BY SHOTS. THE VAR COMPLETED WAS MARKED "NO"TO QUESTION 5: HAVE YOU EVER HAD A REACTION AFTER RECEIVING A VACCINATION, INCLUDING FAINTING OR FEELING DIZZY? FAMILY WAS ADVISED THAT IN THE FUTURE THEY NEED TO MARK THIS QUESTION "YES" AND HAVE IMMUNIZATIONS COMPLETED IN THEIR PHYSICIAN'S OFFICE WHEN POSSIBLE.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Persistent and sporadic return of chest pains, stabbing stomach pains, nausea, aches, pains, fever, eye discomfort, swollen eyelids, chest pressure, shortness of breath,  myocarditis diagnosis by cardiologist- needs anti inflammatory medicine and no exercise for 6-8 weeks.  A previously healthy male nowhas myocarditis for indefinite period of time and in the care of a cardiologist.  The boosters are unsafe for him and doctor informed we MUST REFUSE FURTHER BOOSTERS MANDATED.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram abnormal, Magnetic resonance imaging, Myocarditis, Nausea
Clinical narrative: Persistent and sporadic return of chest pains, stabbing stomach pains, nausea, aches, pains, fever, eye discomfort, swollen eyelids, chest pressure, shortness of breath,  myocarditis diagnosis by cardiologist- needs anti inflammatory medicine and no exercise for 6-8 weeks.  A previously healthy male nowhas myocarditis for indefinite period of time and in the care of a cardiologist.  The boosters are unsafe for him and doctor informed we MUST REFUSE FURTHER BOOSTERS MANDATED.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain, Pyrexia, Swelling of eyelid
Clinical narrative: Persistent and sporadic return of chest pains, stabbing stomach pains, nausea, aches, pains, fever, eye discomfort, swollen eyelids, chest pressure, shortness of breath,  myocarditis diagnosis by cardiologist- needs anti inflammatory medicine and no exercise for 6-8 weeks.  A previously healthy male nowhas myocarditis for indefinite period of time and in the care of a cardiologist.  The boosters are unsafe for him and doctor informed we MUST REFUSE FURTHER BOOSTERS MANDATED.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Burning sensation, Chest discomfort, Dizziness, Inflammation
Clinical narrative: Migraines, tightness/pounding in chest, lightheaded, dizzy, nauseous, pain in left-side of breast, arm soreness and inflammation and burning sensation.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain in extremity, Palpitations, X-ray
Clinical narrative: Migraines, tightness/pounding in chest, lightheaded, dizzy, nauseous, pain in left-side of breast, arm soreness and inflammation and burning sensation.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears began after the vaccine. It has continued to this day. Some days worse than others. Self-treatment with decongestants doesn't help. Ringing is worse now. I am afraid to take a booster shot.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Laboratory test normal, Pain, Pruritus, Rash
Clinical narrative: Severe skin rash- red, itchy , welts , burning and pain . Antihistamine ( Claritin Zyrtec and Benadryl )
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation, Urticaria, Vitamin D decreased
Clinical narrative: Severe skin rash- red, itchy , welts , burning and pain . Antihistamine ( Claritin Zyrtec and Benadryl )
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Breast swelling, Breast tenderness, Induration
Clinical narrative: Extreme soreness in breast (left breast, vaccine given in left arm), extreme soreness in armpit, side of body. All three areas (arm, breast, arm pit) tender to the touch. Side of breast swollen and hard.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Extreme soreness in breast (left breast, vaccine given in left arm), extreme soreness in armpit, side of body. All three areas (arm, breast, arm pit) tender to the touch. Side of breast swollen and hard.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient has been covid free, but has developed tinnitus that has last close to a month at this point.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Continuous tinnitus since around 12/26/2021.  It hasn't stopped for over a month now.  It's very annoying.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Cardiac function test normal, Dizziness, Hypotension, Neurological examination normal
Clinical narrative: Severe hypotension and bradycardia with vision whiteout and dizziness
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Severe hypotension and bradycardia with vision whiteout and dizziness
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient's Mom came in with her 12 yr old daughter asking for 1st dose Moderna Vaccine.  Our Nurse said she forgot about the minimum age required for Moderna Vaccine.  Nurse gave a 12 years old female Moderna Vaccine 0.5ml 1st dose today.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Sensitive skin
Clinical narrative: I didn?t experience any reactions until more than 14 hours post vaccine. Currently at 28 hours post vaccine and have intense chills with very sensitive skin.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dyskinesia, Illness
Clinical narrative: I ran a temperature of 101-102 for three days then lower for a day or so.   About 2 days after my shot I had, I believe I had a neurological reaction. I was in bed and my arms and legs started flailing around uncontrollably. I was so sick, I'm not quite sure this lasted, but I don't believe it lasted very long, but I was in such a weakened state I can not be sure of the duration of the episode. I remember thinking, this must be the chills they have talked about. However, it was not like any chills I had ever experienced or heard of anyone else had. I wasn't sure how rare this was until I had my early checkup on November 4th. At that time I told my doctor how nervous I was to get  the booster.  She said that I shouldn't have the booster/. She had other patients that had neurological issues From the Covid 19 vaccination.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: I ran a temperature of 101-102 for three days then lower for a day or so.   About 2 days after my shot I had, I believe I had a neurological reaction. I was in bed and my arms and legs started flailing around uncontrollably. I was so sick, I'm not quite sure this lasted, but I don't believe it lasted very long, but I was in such a weakened state I can not be sure of the duration of the episode. I remember thinking, this must be the chills they have talked about. However, it was not like any chills I had ever experienced or heard of anyone else had. I wasn't sure how rare this was until I had my early checkup on November 4th. At that time I told my doctor how nervous I was to get  the booster.  She said that I shouldn't have the booster/. She had other patients that had neurological issues From the Covid 19 vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling. Small bumps at locations of volbella (filler) injections swollen badly
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test normal, Diarrhoea, Dyspepsia, Dysphagia
Clinical narrative: Symptoms- swollen lymph nodes for a little over 2 weeks, lymph nodes were very painful, diarrhea for over a week, mucus in stool for almost 3 weeks, stomach pain for almost 2 weeks, trouble swallowing for over a week, extreme fatigue for about a week, heartburn for several months
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Mucous stools
Clinical narrative: Symptoms- swollen lymph nodes for a little over 2 weeks, lymph nodes were very painful, diarrhea for over a week, mucus in stool for almost 3 weeks, stomach pain for almost 2 weeks, trouble swallowing for over a week, extreme fatigue for about a week, heartburn for several months
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dyspnoea, Headache, Hepatitis viral test negative
Clinical narrative: Pt had the First Moderna Covid shot on  Nov  5 2021.     Symptoms started the same day.  Headache, Achyness, chills and dyspnea. on November 10, pt noted lower extremity  petechia,  and  lower extremity and soft palate bruising.   She came to the Emergency room on November 14th 2021,  She had a platlet count of 5000 on that day. She went home and  came back the next day with a platlet count of 4000. She was given IVIG and steriods , admitted and left the hospital on  November 17 th with a platlet count of 16000.    She came back and was admitted on the November 30th with  Platlet count of  7000, and I believe was DCed  with platlet count of 55000 She had no bruising  or petichia prior to  November  10th,  and   the last platlet count I have on her in the medical records was November 2019 and that was 166000  So normal at that time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Infectious mononucleosis, Mononucleosis heterophile test positive, Pain, Petechiae
Clinical narrative: Pt had the First Moderna Covid shot on  Nov  5 2021.     Symptoms started the same day.  Headache, Achyness, chills and dyspnea. on November 10, pt noted lower extremity  petechia,  and  lower extremity and soft palate bruising.   She came to the Emergency room on November 14th 2021,  She had a platlet count of 5000 on that day. She went home and  came back the next day with a platlet count of 4000. She was given IVIG and steriods , admitted and left the hospital on  November 17 th with a platlet count of 16000.    She came back and was admitted on the November 30th with  Platlet count of  7000, and I believe was DCed  with platlet count of 55000 She had no bruising  or petichia prior to  November  10th,  and   the last platlet count I have on her in the medical records was November 2019 and that was 166000  So normal at that time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Streptococcus test negative
Clinical narrative: Pt had the First Moderna Covid shot on  Nov  5 2021.     Symptoms started the same day.  Headache, Achyness, chills and dyspnea. on November 10, pt noted lower extremity  petechia,  and  lower extremity and soft palate bruising.   She came to the Emergency room on November 14th 2021,  She had a platlet count of 5000 on that day. She went home and  came back the next day with a platlet count of 4000. She was given IVIG and steriods , admitted and left the hospital on  November 17 th with a platlet count of 16000.    She came back and was admitted on the November 30th with  Platlet count of  7000, and I believe was DCed  with platlet count of 55000 She had no bruising  or petichia prior to  November  10th,  and   the last platlet count I have on her in the medical records was November 2019 and that was 166000  So normal at that time.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears 24/7.  Has not resolved.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Took shot 1/14, experienced burning around the injection site and sore arm, not out of usual. However, next morning (1/15) woke up with a headache and slight fever. Upon going to the kitchen to take medication for the headache, passed out on the floor. Was dizzy for the entire day, and could not leave the couch upon being helped there by my family. Dizzy symptoms continued into 1/16, but were not as intense as 1/15.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Took shot 1/14, experienced burning around the injection site and sore arm, not out of usual. However, next morning (1/15) woke up with a headache and slight fever. Upon going to the kitchen to take medication for the headache, passed out on the floor. Was dizzy for the entire day, and could not leave the couch upon being helped there by my family. Dizzy symptoms continued into 1/16, but were not as intense as 1/15.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: I am a healthy woman, 49 years of age and active. In October of 2021, 3 months after 2nd vaccination, I started experiencing muscle weakness in my legs. It continued to get worse where I could not walk from our bedroom to kitchen without having to sit down. If I pushed myself to continue on I would collapse. I needed to use a cane. Out of nowhere in January 2022 this went away and I am back to normal. Not sure if this was from vaccine but thought I should report it in case others experienced the same thing.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I was working with my partner an EMT as mobile vaccinators, we drive to patients houses to administer vaccines. I was trained by the agency that the EMTs duties is the person verifying the patients vaccines in the ALERT system and helping the patient with paperwork and monitoring for reactions. The duties for the LVN as trained was vaccine withdrawal, administration and temp recording of vaccine cooler.  The roster for the day stated 5 Moderna booster vaccines were scheduled for the address where patient was. Upon arrival, my partner received vaccine cards from all the patients, signatures, and verified vaccines in the ALERT system giving me the green light to vaccinate. Moderna booster 0.25 mL was given to patient of 15 years of age on  01/28/2022 without me realizing the patient was under 18 years of age as I sign the paper authorization after vaccine administration. Mom was notified of event and had no concerns or questions for me. I advised to monitor for any changes, reactions, or side effects and report them to patients physician.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood test, Cardiac flutter, Electrocardiogram, Extrasystoles
Clinical narrative: I experienced fluttering in my chest and listened to my heart using a stethoscope.  I noticed an irregular heart rhythm (PVCs) and skipped beats. I went to my PCP and an EKG confirmed what I heard. No family history of heart defects. All labs and BP within normal limits. Cardiologist also confirmed arrhythmia and noted it was highly unusual for a person my age and good health to experience these symptoms.It puts me at high risk of stroke and/or heart attack.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Lipids, Metabolic function test, Ventricular extrasystoles
Clinical narrative: I experienced fluttering in my chest and listened to my heart using a stethoscope.  I noticed an irregular heart rhythm (PVCs) and skipped beats. I went to my PCP and an EKG confirmed what I heard. No family history of heart defects. All labs and BP within normal limits. Cardiologist also confirmed arrhythmia and noted it was highly unusual for a person my age and good health to experience these symptoms.It puts me at high risk of stroke and/or heart attack.
Age: 37.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Menstrual disorder, Pruritus
Clinical narrative: Severe itching of both calves at all hours of the day but flared up the most at night. After a couple of weeks, the itching spread to both thighs (on the front and back) while also continuing on both calves. No topical treatment (including  0.1% Triamcinolone Acetonide Cream) or oral treatment (including Benadryl) alleviated the itching. The itching continued upon receipt of my second Moderna dose  on October 20, 2021 and continued for approximately four weeks, finally resolving around Thanksgiving 2021. There have been no flare-ups to date. There was no discoloration or swelling of the skin; just an intense itch.  Additionally, my menstrual cycle has been impacted as I now get my period every 14-21 days as opposed to my regular cycle of 28-30 days. This has been the case since receiving my first Moderna vaccine on September 22, 2021.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: I woke up the day after my booster shot with a huge red, swollen, and hot rash that made a circle around the shot area. This gradually grew over the next couple of days. As I am filling this form out, the redness, and swelling has gone down tremendously, but there is still a little redness from the growth of the past few days.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chest X-ray abnormal, Death, Decreased appetite, Dyspnoea
Clinical narrative: Upon reviewing skilled nursing facility's chart, it appears his temperature was normal the day of vaccination, and the day after vaccination. On 12/24/21, however, his temperature increased to 100.9 degrees. It came down later that day and started between 97.1 and 99.8 in the days following. Nursing notes state that patient was noted to have reduced appetite and difficulty breathing. On 12/28/21, an XRay was ordered due to difficulty breathing and loratadine 10mg daily was started "for congestion". The XRay findings report that there was a slight right lower lobe infiltrate. Left side appeared clear and heart unremarkable. Doxycycline 100mg BID started in response. On 12/31/21, at approximately 7pm, patient called nursing and asked for the doctor to be contacted because he was having an extremely difficult time breathing. Nursing noted he was using his accessory muscles to breath and his oxygen sats were 70-73% on room air. Nurse applied oxygen 3L and it did not increase O2 sats. Breathing treatment administered and MD contacted. Orders to go to ER were given. EMS arrived and upon repositioning / transferring patient, the patient became unresponsive. CPR was initiated but patient was never able to regain a sustained heartbeat. Per facility staff, family denies having given authorization for COVID booster to be given and believes that booster was cause of death.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Lung infiltration, Oxygen saturation decreased, Respiratory tract congestion, Resuscitation, Unresponsive to stimuli
Clinical narrative: Upon reviewing skilled nursing facility's chart, it appears his temperature was normal the day of vaccination, and the day after vaccination. On 12/24/21, however, his temperature increased to 100.9 degrees. It came down later that day and started between 97.1 and 99.8 in the days following. Nursing notes state that patient was noted to have reduced appetite and difficulty breathing. On 12/28/21, an XRay was ordered due to difficulty breathing and loratadine 10mg daily was started "for congestion". The XRay findings report that there was a slight right lower lobe infiltrate. Left side appeared clear and heart unremarkable. Doxycycline 100mg BID started in response. On 12/31/21, at approximately 7pm, patient called nursing and asked for the doctor to be contacted because he was having an extremely difficult time breathing. Nursing noted he was using his accessory muscles to breath and his oxygen sats were 70-73% on room air. Nurse applied oxygen 3L and it did not increase O2 sats. Breathing treatment administered and MD contacted. Orders to go to ER were given. EMS arrived and upon repositioning / transferring patient, the patient became unresponsive. CPR was initiated but patient was never able to regain a sustained heartbeat. Per facility staff, family denies having given authorization for COVID booster to be given and believes that booster was cause of death.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Use of accessory respiratory muscles
Clinical narrative: Upon reviewing skilled nursing facility's chart, it appears his temperature was normal the day of vaccination, and the day after vaccination. On 12/24/21, however, his temperature increased to 100.9 degrees. It came down later that day and started between 97.1 and 99.8 in the days following. Nursing notes state that patient was noted to have reduced appetite and difficulty breathing. On 12/28/21, an XRay was ordered due to difficulty breathing and loratadine 10mg daily was started "for congestion". The XRay findings report that there was a slight right lower lobe infiltrate. Left side appeared clear and heart unremarkable. Doxycycline 100mg BID started in response. On 12/31/21, at approximately 7pm, patient called nursing and asked for the doctor to be contacted because he was having an extremely difficult time breathing. Nursing noted he was using his accessory muscles to breath and his oxygen sats were 70-73% on room air. Nurse applied oxygen 3L and it did not increase O2 sats. Breathing treatment administered and MD contacted. Orders to go to ER were given. EMS arrived and upon repositioning / transferring patient, the patient became unresponsive. CPR was initiated but patient was never able to regain a sustained heartbeat. Per facility staff, family denies having given authorization for COVID booster to be given and believes that booster was cause of death.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Tenderness, Urticaria
Clinical narrative: Pt. states @ 300pm area became Itchy with Red whelps. Whelps lasted lasted for 24 hours. After 24 hours area became red. From Wednesday to Friday normal color returned. Today only painful to touch. No medication taken. Nothing applied to area.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Electromyogram, Gait disturbance, Limb discomfort
Clinical narrative: 1 hr post vaccine developed 102.6 fever, bodyache, chills. Symptoms lasted 2 weeks with subsequent intermittent fevers. After fevers broke after the 2 week mark legs became affected and pain to bilateral anterior thighs and difficulty walking.  3 covid tests post vaccination--first 2 negative although symptomatic, #3 came back positive.  Today still with pain to bilateral anterior thighs and difficulty walking
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: 1 hr post vaccine developed 102.6 fever, bodyache, chills. Symptoms lasted 2 weeks with subsequent intermittent fevers. After fevers broke after the 2 week mark legs became affected and pain to bilateral anterior thighs and difficulty walking.  3 covid tests post vaccination--first 2 negative although symptomatic, #3 came back positive.  Today still with pain to bilateral anterior thighs and difficulty walking
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 1 hr post vaccine developed 102.6 fever, bodyache, chills. Symptoms lasted 2 weeks with subsequent intermittent fevers. After fevers broke after the 2 week mark legs became affected and pain to bilateral anterior thighs and difficulty walking.  3 covid tests post vaccination--first 2 negative although symptomatic, #3 came back positive.  Today still with pain to bilateral anterior thighs and difficulty walking
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: She was passing out/she was in "poor condition"; They thought she was having a heart attack; Her blood pressure was up; Just a bad reaction to Moderna; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition") in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition") (seriousness criterion medically significant), CARDIAC DISCOMFORT (They thought she was having a heart attack), HYPERTENSION (Her blood pressure was up) and VACCINATION COMPLICATION (Just a bad reaction to Moderna). The patient was treated with OXYGEN on 04-Feb-2021 for Adverse event, at an unspecified dose and frequency. In February 2021, LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition"), CARDIAC DISCOMFORT (They thought she was having a heart attack), HYPERTENSION (Her blood pressure was up) and VACCINATION COMPLICATION (Just a bad reaction to Moderna) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: high (High) BP was up. On 04-Feb-2021, Electrocardiogram: results not provided (Inconclusive) Results not provided.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that they told her that she should go to the hospital right away. They sent her in an ambulance to the hospital. During the ride, they gave her oxygen. She doesn't remember receiving any medications in the ambulance or ER  It was stated that she stayed in the ER until her signs corrected themselves.  She was indicated not to receive the second dose..  She was on medication for blood pressure issues.  Company Comment - This spontaneous case concerns a 84 year old female patient with no relevant medical history, who experienced the serious unexpected event of loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 84 year old female patient with no relevant medical history, who experienced the serious unexpected event of loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: 5 days after 2nd injection, I woke up with rash at injection site.  Red and itched.  Spoke with Dr. office by phone, Nurse suggested over the counter meds.  The rash spread around arm.  Then began to fade.  Whole event lasted 10 days.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: covid test result=Positive / covid test date=28/Dec/2021; covid test result=Positive / covid test date=28/Dec/2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 (Lot number: EF3592) at the age of 37 years as dose 2, single and administered in arm right, administration date 23Aug2021 (Lot number: FC3180) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: maybe penicillin" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "covid test result=Positive / covid test date=28/Dec/2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Chest pain, Dizziness, Exercise tolerance decreased
Clinical narrative: covid test result=Positive / covid test date=28/Dec/2021; covid test result=Positive / covid test date=28/Dec/2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 (Lot number: EF3592) at the age of 37 years as dose 2, single and administered in arm right, administration date 23Aug2021 (Lot number: FC3180) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: maybe penicillin" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "covid test result=Positive / covid test date=28/Dec/2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Palpitations
Clinical narrative: covid test result=Positive / covid test date=28/Dec/2021; covid test result=Positive / covid test date=28/Dec/2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 (Lot number: EF3592) at the age of 37 years as dose 2, single and administered in arm right, administration date 23Aug2021 (Lot number: FC3180) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: maybe penicillin" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "covid test result=Positive / covid test date=28/Dec/2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: covid test result=Positive / covid test date=28/Dec/2021; covid test result=Positive / covid test date=28/Dec/2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 (Lot number: EF3592) at the age of 37 years as dose 2, single and administered in arm right, administration date 23Aug2021 (Lot number: FC3180) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: maybe penicillin" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "covid test result=Positive / covid test date=28/Dec/2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Chills, Dizziness, Fatigue, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 01-NOV-2021, the patient experienced dizziness, body aches, severe chills, fatigue, fever of 101 F., and headache. On 02-NOV-2021, the patient experienced rapid heart rate, and face cheeks are flush and hot to touch. On 04-NOV-2021, the patient experienced vaginal burning, burning itching vaginal pain, white milky discharge that has chunks in it, and left breast and nipple tingled. On 05-NOV-2021, treatment medications included: fluconazole. On 08-NOV-2021, the patient experienced allergic reaction. On 01-DEC-2021, Laboratory data included: Vaginal burning sensation (NR: not provided) burning at 550 degrees. On 15-DEC-2021, treatment medications included: gabapentin. On 25-DEC-2021, treatment medications included: valaciclovir hydrochloride. On 20-JAN-2022, treatment medications included: hydroxychloroquine. Laboratory data (dates unspecified) included: Bacterial test (NR: not provided) Negative, Herpes simplex test (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Human papilloma virus test (NR: not provided) Negative. Additional treatment medications (dates unspecified) included: valaciclovir hydrochloride, hydrocortisone, methylprednisolone sodium phosphate, and prednisone. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, body aches, severe chills, fever of 101 F., and headache on 03-NOV-2021, and left breast and nipple tingled, had not recovered from burning itching vaginal pain, rapid heart rate, face cheeks are flush and hot to touch, white milky discharge that has chunks in it, and vaginal burning, and the outcome of fatigue and allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220141775.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Herpes simplex test, Herpes virus test, Hot flush, Human papilloma virus test
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 01-NOV-2021, the patient experienced dizziness, body aches, severe chills, fatigue, fever of 101 F., and headache. On 02-NOV-2021, the patient experienced rapid heart rate, and face cheeks are flush and hot to touch. On 04-NOV-2021, the patient experienced vaginal burning, burning itching vaginal pain, white milky discharge that has chunks in it, and left breast and nipple tingled. On 05-NOV-2021, treatment medications included: fluconazole. On 08-NOV-2021, the patient experienced allergic reaction. On 01-DEC-2021, Laboratory data included: Vaginal burning sensation (NR: not provided) burning at 550 degrees. On 15-DEC-2021, treatment medications included: gabapentin. On 25-DEC-2021, treatment medications included: valaciclovir hydrochloride. On 20-JAN-2022, treatment medications included: hydroxychloroquine. Laboratory data (dates unspecified) included: Bacterial test (NR: not provided) Negative, Herpes simplex test (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Human papilloma virus test (NR: not provided) Negative. Additional treatment medications (dates unspecified) included: valaciclovir hydrochloride, hydrocortisone, methylprednisolone sodium phosphate, and prednisone. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, body aches, severe chills, fever of 101 F., and headache on 03-NOV-2021, and left breast and nipple tingled, had not recovered from burning itching vaginal pain, rapid heart rate, face cheeks are flush and hot to touch, white milky discharge that has chunks in it, and vaginal burning, and the outcome of fatigue and allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220141775.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 01-NOV-2021, the patient experienced dizziness, body aches, severe chills, fatigue, fever of 101 F., and headache. On 02-NOV-2021, the patient experienced rapid heart rate, and face cheeks are flush and hot to touch. On 04-NOV-2021, the patient experienced vaginal burning, burning itching vaginal pain, white milky discharge that has chunks in it, and left breast and nipple tingled. On 05-NOV-2021, treatment medications included: fluconazole. On 08-NOV-2021, the patient experienced allergic reaction. On 01-DEC-2021, Laboratory data included: Vaginal burning sensation (NR: not provided) burning at 550 degrees. On 15-DEC-2021, treatment medications included: gabapentin. On 25-DEC-2021, treatment medications included: valaciclovir hydrochloride. On 20-JAN-2022, treatment medications included: hydroxychloroquine. Laboratory data (dates unspecified) included: Bacterial test (NR: not provided) Negative, Herpes simplex test (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Human papilloma virus test (NR: not provided) Negative. Additional treatment medications (dates unspecified) included: valaciclovir hydrochloride, hydrocortisone, methylprednisolone sodium phosphate, and prednisone. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, body aches, severe chills, fever of 101 F., and headache on 03-NOV-2021, and left breast and nipple tingled, had not recovered from burning itching vaginal pain, rapid heart rate, face cheeks are flush and hot to touch, white milky discharge that has chunks in it, and vaginal burning, and the outcome of fatigue and allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220141775.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge, Vulvovaginal burning sensation, Vulvovaginal pruritus
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 01-NOV-2021, the patient experienced dizziness, body aches, severe chills, fatigue, fever of 101 F., and headache. On 02-NOV-2021, the patient experienced rapid heart rate, and face cheeks are flush and hot to touch. On 04-NOV-2021, the patient experienced vaginal burning, burning itching vaginal pain, white milky discharge that has chunks in it, and left breast and nipple tingled. On 05-NOV-2021, treatment medications included: fluconazole. On 08-NOV-2021, the patient experienced allergic reaction. On 01-DEC-2021, Laboratory data included: Vaginal burning sensation (NR: not provided) burning at 550 degrees. On 15-DEC-2021, treatment medications included: gabapentin. On 25-DEC-2021, treatment medications included: valaciclovir hydrochloride. On 20-JAN-2022, treatment medications included: hydroxychloroquine. Laboratory data (dates unspecified) included: Bacterial test (NR: not provided) Negative, Herpes simplex test (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Human papilloma virus test (NR: not provided) Negative. Additional treatment medications (dates unspecified) included: valaciclovir hydrochloride, hydrocortisone, methylprednisolone sodium phosphate, and prednisone. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, body aches, severe chills, fever of 101 F., and headache on 03-NOV-2021, and left breast and nipple tingled, had not recovered from burning itching vaginal pain, rapid heart rate, face cheeks are flush and hot to touch, white milky discharge that has chunks in it, and vaginal burning, and the outcome of fatigue and allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220141775.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: STARTING TO LOOSE MY MIND; TINNITUS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1)  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: Unknown) dose was not reported, 1 total, administered to left arm on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-DEC-2021, following covid-19 vaccine ad26.cov2.s, the patient experienced tinnitus (dose number in series 2). Reporter stated that, the ringing in his ears started 5 mins after taking the vaccine and has not stopped since. The sound can go higher or lower. The patient has seen his neurologist and and ENT(ear, nose, and throat) specialist.  On an unspecified date, the patient experienced starting to loose my mind (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, and the outcome of starting to loose my mind was not reported. This report was non-serious.