chrisvoncsefalvay/vaers-outcomes huggingface dataset:
60 y/o man with a PMH of ESRD on HD (TThSat; previously on PD), CAD s/p 3V CABG, iCM (LVEF 20% -- > 45-50%), AFL s/p DCCV in 2/2020, diabetes, hypertension, hyperlipidemia, and colon cancer s/p sigmoid resection (2015) who p/w 2 weeks SOB and dry cough, found to be COVID+ despite 3 doses vaccine.     # COVID Full vaccinated with Pfizer, including booster (3rd dose) ~ 1 month prior to admission. SOB x 2-3 weeks with cough productive of green phlegm. S/p outpt CAP tx with azithromycin w/o improvement followed by levo w some improvement, but still had some SOB and persistent dry cough. 11/1/21 Rapid COVID positive as outpatient; child at home also tested positive for COVID. On admission, COVID PCR on admission also positive; cycle threshold 28.6. eRVP negative. In ED, febrile to 100.7F, and satting 90% on RA, so placed on 2L O2. Inflammatory markers elevated. Procal 0.35, but ISO ESRD. CXR without GGOs or consolidations. Given 1x dose remdesivir (11/2/21) before discontinuation given ESRD and suspicion for being late in COVID Course. Given O2 requirement, started on dexamethasone (11/2-3/21). Quickly weaned off O2; ambulatory sats 88% and higher. No indication for antibiotics. Supportive care with APAP, Tessalon perles, and Robitussin. Pt eager to get home on 11/3/21, so reviewed return to hospital precautions and discharged with isolation instructions.
In November 1999, the pt had a bilateral lung transplant. He was administered immunosuppressive therapy. In January 2000, the pt experienced viral pneumonia. In May 2000, the pt experienced pneumococcal pneumonia. On 10/2/00, bronchoalveolar lavage revealed heavy filamentous organisms in 3 of the 4 tubes. On 10/5/00, the pt experienced decreased pulmonary function with a decline in forced expiratory volume and bilateral pleural effusions. The pt was hospitalized from 10/5/00 to 10/13/00. He was placed on itraconazole. On 10/18/00, the pt developed nonpainful lesions on the shaft of his penis and buttocks. None of the lesions appeared secondarily infected. He was placed on Augmentin. The lesions formed a confluent patch on his skin on other parts of the body. On 10/20/00, it was noted his energy level was 30%. There was no fever, and skin lesions were vesicular appearing, but did not hurt or itch. There were multiple vesicular lesions, many of which were on an erythematous base. They were scattered in multiple dermatomes on the face, neck, arm, back, chest, and upper thighs. The physician was not sure if the pt experienced reactivation of the vaccine strain virus or breakthrough wild type chickenpox. Subsequently the pt recovered. There was an uncomplicated recovery with crusting of lesions on acyclovir. The pt had no history of chickenpox. There was no recent exposure to wild-type varicella preceding his breakout.
right arm was itching; right arm was swelling; right arm was warm/and hot to the touch; lump at the injection site; knot at the injection site; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE INDURATION (knot at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm was sore). On 30-Mar-2021, the patient experienced PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE INDURATION (knot at the injection site). At the time of the report, PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE INDURATION (knot at the injection site) and PAIN IN EXTREMITY (right arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 07-Aug-2021 and included Non-significant information
was in severe pain; spiked a high temp; Could not walk or raise her arms; Could not walk; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced pain, high temperature, mobility decreased and unable to walk. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the pain, high temperature, mobility decreased and unable to walk were recovered/resolved.   It was unknown if the reporter considered the pain, high temperature, mobility decreased and unable to walk to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. The patient was vaccinated with Meningitis B vaccine and experienced severe side effects. The patient had a high temperature, severe pain, and could not walk or raise her arms for 4 days. The reporter stated the pediatrician did not seem surprised and he cancelled the second shot. No further information was provided.
Patient had a Pfizer booster the day before. He then wanted to receive a Fluad and the first dose of Shingrix. He started closing his eyes approximately 3 minutes after the vaccines. His left side of the body shook for 2 seconds showing signs of seisures. His face turned pale/yellow. Emergency services called. The patient's vitals, blood oxygen and blood glucose were checked by the emergency service team. All showed normal. Patient was carried out of the pharmacy into the parking lot where they rechecked his levels. Patient was allowed to go home right after. He is doing fine at home
started with cold sores on lips that progressed to inside of nose then after taking shower notices small red marks on stomach and 2 on left arm.  They did not itch except when exposed to warmth.
Patient received a tetanus shot, on Thursday 06/3/10 and then had pain, nausea and vomiting 2 days later on Sunday 06/05/10. When examined, patients injection site (deltoid) was slightly edematous, warm to touch and hard.
Rash on face neck limbs and body 24 days after my 2nd shot. Rash has lasted over 3weeks
Major hair loss over proceding 3 months after vaccination. (Over 70% of hair loss). Alopecia.
terrible diarrhea; lost 5 pounds; she is not as tired as she was; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EV6204) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 13Mar2021, outcome "recovered" (18Mar2021 06:00), described as "terrible diarrhea"; WEIGHT DECREASED (non-serious) with onset Mar2021, outcome "unknown", described as "lost 5 pounds"; FATIGUE (non-serious) with onset Mar2021, outcome "recovering", described as "she is not as tired as she was". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea.  Additional information: She said that Saturday late afternoon she had diarrhea which she didn't pay it attention and didn't connect it, but then Sunday through Tuesday she had the worst diarrhea of her life and she would be 80 in a month, to where she barely got to the toilet and it poured out of her all day and during the night. Her husband got her Imodium, which made it more controlled and she could get to the toilet, and the diarrhea continued to last night though not as bad, it was still pouring out. She said this morning she took Imodium and had only went one time at 06:00AM, and she has not had any since. She said she dropped 5 pounds, she thinks she was pooping everything out, it was the craziest thing. She said she was not as tired as she was, but she also didn't know if she should continue taking Imodium to treat the symptom. She said she was better now. Reporter said that there were 24 tablets in pack, and was supposed to take two the first time she believes, it said take two tabs after the first loose stool, and one for each occurrence after that and no more than 4 in 24 hours, which she stuck to that.  No follow-up attempts are possible. No further information is expected.
little dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 07Feb2021 (Lot number: EL9264) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney stones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "little dizzy". No follow-up attempts are possible. No further information is expected.
I woke up at 2AM having what appeared to be a violent seizure with uncontrollable shaking and muscle spasms lasting roughly 40 minutes. This was far worse than just simple chills. Upon arriving at the ER the shaking had ceased but I carried a fever between 102 and 103.5 throughout the following 24 hours, extreme pain in muscles in my feet, legs, back, etc.
Vaccine given 6:00 pm 10/9/12 reaction began 10/10/12 in the AM large, swollen, red area around injection site on right posterior upper arm.
MOTHER REPORTS IMMUNIZATION ON 4/11/2005 AT APRO. 2:00 PM.  NOTICED RT ARM RED SWOLLEN AND CHILD C/O ITCHING ON 4/12/2005.  MOTHER REPORTS CHILD WAS GIVEN TYLENOL AND COLD COMPRESSESS.
The patient was brought to the ED by EMS and evaluated in the ED on 8/9/23 for shortness of breath. Earlier that evening prior to the ED, the patient went for a walk and became short of breath. EMS was called and he was given a nebulizer and started on supplemental O2. Per EMS, the patient appeared confused. Additionally, the patient reports he did take a home COVID test a few days prior  (8/4/23) which returned positive. He additionally reports chills and fevers. In the ED, he was hypoxic with an SpO2 in the upper 80's on room air. He was placed on 2L O2 via NC with improvement. Ultimately, the patient was admitted 8/9/23 - 8/11/23, with discharge diagnoses including acute respiratory failure with hypoxemia due to COVID pneumonia and COPD with acute exacerbation, among other diagnoses. The patient was treated with dexamethasone, DuoNebs, and inhalers. He was able to wean off supplemental O2. Of note, the patient has received the primary COVID vaccine series and one booster.
Received Moderna dose series through the department, with patient's daughter stating series was completed on 2/10/21. No record to verify this date. Patient presented to ED after a fall for a fracture of superior pubic rami on 3/24/21. Was found to be positive for COVID-19 during prescreening prior to transfer to medical floor.  Reported no symptoms of COVID-19 infection during hospital admission.
Pt recvd 1st dose of Hep B vax on 26AUG91 w/no problems; pt recvd 2nd dose Hep B vax 26SEP91 immed following devel rash; next day devel flushing, diaphoresis & shakiness; unable to concentrate because of weakness; taken to ER;
neurological issues and right sided paralysis.; neurological issues and right sided paralysis.; This spontaneous report was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving the vaccine, the patient suffered neurological issues and right sided paralysis. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), symptoms have resulted in physical limitations not present prior to using the vaccine and experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition, in addition, the patient sustained severe and permanent personal injuries and 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. Patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, right sided paralysis was considered a medically significant event.
headache; tiredness; This is a spontaneous report from a contactable consumer (patient's husband) reported for a patient (wife) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced headache and tiredness. Caller wanted to know can you take advil to relieve symptoms. Caller also had swollen lymph nodes before vaccine. Cold transfer for AE side effect due to long hold. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Severe rash all over body. Breaking out in Hives which look like my skin has been attacked/severely scratched. There is no trigger for the itching and hives, they come and are extremely severe and uncomfortable. They are raised, dark red and flaming hot to the touch. They have lasted for a month, and there is no end in sight.  Treatment attempted has been lotion everyday, changing body wash and shampoo, changing laundry detergent, dryer sheets, etc. Switched from taking Claritin everyday to trying Histamines, then trying Allegra Hives, then adding benedryl on top of that. Nothing has worked.  Attempted putting hydrocortisone on body, extra strength Hydrocortisone, aloe vera, ice, as well as Triamcinolone Acetonide Cream, and Clobetosol cream. None of the above soothed the itching. Finally went to urgent care where PA informed me this is very likely due to the booster shot and there is not much to do except wait it out. Was prescribed topical steroids to try and combat the itching, but no cure for itching.
02/25/2021 by 12:30 feeling very tired , did not sleep well as right arm was painful and hot to touch.  02/26/2021 weak, lethargic, pain right arm , redness, swelling and warmth 1" x2", Temp 101.7, Tylenol at  12 noon and temp 100.7 @ 6PM Tylenol given,  did not get out of bed till 8PM, only drank water during day, finally Jello around 8 PM.  02/27/2021 still lethargic, resting in bed, right arm red 3"x 3" and warm, itchy, took Claritin and did cool compresses and hydrocortisone cream as had been directed by Dr. after first vaccine .  On 2/28/2021redness 3"x4" with two painful bright red itchy spots near inside of right arm continued with  treatment.  On 02/29/2021 area 4x4 but less redness, still sore and itchy.   By 03/01/2021 redness , itching, swelling, pain gone.
Arm red, hard and sore at injection site.  Muscles aches from neck to back both sides, but more so on injection side of body. Fatigue, feel crummy all over as if getting the flu, mild temp.
breakthrough covid + 10.3.21 w/ new onset Afib RVR, no resp symptoms
This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 17-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 38 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Hives on left thigh; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on left thigh) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced URTICARIA (Hives on left thigh). At the time of the report, URTICARIA (Hives on left thigh) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Teatment given included Benadryl.
Parsonage Turner syndrome (Brachial Neuritis). Medication, occupational therapy
On 3/25 I had a sore arm with firmness around the injection site.  Today I woke up very early with fever and chills and feeling pretty ill.  Urinated and crawled into bed and put electric blanket on high until I felt warm. Got up about 7:00 and took my temperature  and it was about 100.  Then it varied between 99 and 102.5 all day. Had blurred vision and body aches and bad headache and nausea. .Took Tylenol or hydrocodone which helped with keeping temp closer to 100 but I?d fall asleep and forget to take Tylenol and it would go back to 102. I didn?t have anyone to drive me that I felt comfortable enough to risk exposure in case it was an actual illness and not the vaccine. I considered calling an ambulance but decided to wait and see if I could get my temp under control. This evening I?m  at 100 again (I just took it again) but thought my fever had broken as I didn?t feel I was radiating heat like I felt when it was 102. My normal temp is usually around 97. I haven?t taken anything Tylenol or hydrocodone since about 3:00 but I will take just plain Tylenol now.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  The reporter stated that because their facility had not been able to download the digital data logger, they have been put on hold at the moment and could not administer the Moderna COVID-19 vaccine to patients until an assessment was made. There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. Reporter stated that no adverse reactions were reported by any patients.  No treatment medication were provided.
Itchy skin, raised bumps/rash, various parts of the body: arms, legs, back, scalp, behind ears, near hair lines
over the next few weeks, I began to have menopausal symptoms again.  hot flashes all day and night, cramping in my stomach like I was going to get my period again.  This is after not having a period for 5 years.  I did not bleed but hot flashes continued to be strong for the next 5 months.  now they have lessoned.   I was extremely tired and was no longer able to go to the gym to workout.  I was normally at the gym 5 times a week.  I have gained 30 lbs because of how I feel. I began feeling weird.  just not like myself.  I had anxiety and chest pain, headaches and leg pain.  one of my legs would swell and then go down. I was getting dizzy and my vision was foggy,  I was sweating and this was when I called ambulance. the second time I went to hospital I was on business and missed my meetings because I went to hospital with chest and abdomin pain and bad headache.