chrisvoncsefalvay/vaers-outcomes huggingface dataset:
46 year old student came in today c/o Had Tdap vaccine at 9 am with our nurses and started getting out of it by 5 pm, fever, fogginess and he thought he was doing Ok but could not do work as he felt bad and lied down and went to bed and it was not long when his muscle spasmed in the GI track inside, deep and at times the breathing muscle felt spasm and his fever went too high but not sure how high (he is thinking maybe 104 as his temp ring pointed to 4 points above normal) and was delirious and was talking in his sleep and had pain and could not sleep and the spasm continued on Saturday and got 4 hours of sleep that night but the spasm became less frequent and then on Saturday night he got fruit juices to get bett 46 year old student came in today c/o Had Tdap vaccine at 9 am with our nurses on 04/01/2022 and started getting out of it by 5 pm, fever, fogginess and he thought he was doing Ok but could not do work as he felt bad and lied down and went to bed and it was not long when his muscle spasmed in the GI track inside, deep and at times the breathing muscle felt spasm and his fever went too high but not sure how high (he is thinking maybe 104 as his temp ring pointed to 4 points above normal) and was delirious and was talking in his sleep and had pain and could not sleep and the spasm continued on Saturday and got 4 hours of sleep that night but the spasm became less frequent and then on Saturday night he got fruit juices to get better hydrated and some of the fruits he does not usually eat, banana and mango and it made more gas and re trigger the spasm. Then got better yesterday evening. Got 4 hours of sleep last night. Today he feels tired, he did not feel spasm but it felt his stomach muscle were not working to move and felt increase gas from the fruit and felt distended and more painful and felt expanding up to his chest and had DIB if he lies down, better with sitting up and did exercise and stretching which helped and no more chest pain.  had BM this am, small pieces, not hard at his normal, no blood. He is passing gas today but not yesterday. Drank 2 L of fluid a day. His diet "Weird" "concentrated powder food that he devolve and take it as meal replacement and only eats 2 meals a week consistent with shredded wheat and apple" which is not new for the past 7 years. He started that initially started doing that for efficiency and helped with hypoglycemia, drinks enough fluid. Goes once a day BM, does not strain and takes fiber supplements. Gets dirt and cuts all the time and he feels he got natural immunization to dirt. He had horrible sleep the entire week even before the vaccine. That is not usual for him where he gets bad sleep for a week or so. When he does not sleep well his body does does not regulate his temp.  Took aleve and it helped.
Muscle twitching (back, legs, arms); This is a spontaneous report from a non-contactable other health care professional, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), on an unspecified date (at the age of 24-year-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. Medical history of the patient included polycystic ovarian syndrome and obesity. The patient did not have any drug, food or other product allergy. Concomitant medications were not reported. On 26Mar2021, the patient had experienced muscle twitching (back, legs and arm as reported). The patient had not received any treatment for the clinical events. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscle twitching was recovering.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient Initials combined and entered in first name field. 2. Patient Country entered. 3. RMH Verbatim updated to match with source and Notes added as PCOS per source. 4. Final sentence updated as No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
-See attached chart notes for neuromuscular weakness & resultant intubation, hospitalization. 9/11/2020. Patient is a 78 y.o. female on whom I have been asked to consult for evaluation and treatment of probable GBS. She did yard work on 9/8/20 which made her tired. That afternoon she began noticing numbness and tingling of her fingers and toes. That evening she could not get off the toilet; she was too weak in the legs. She needed to use a medical alert device to get help. Normally she used a walker. She notified EMS, who transported her to the hospital. In the ED she was found to hypertensive (190s), O2 sats 87%, urine with possible infection, and CXR with possible pneumonia vs aspiration but normal procalcitonin. She has required bipap. Admitted 9/9/20. Yesterday she reported improved sensation in her limbs. On exam for hospitalist, she was areflexic and weak. She had LP, which showed Prot 75. Decision was last night to delay IVIG to see how she looks today. She reports numbness now rising up to her lower abdomen. She is still requiring bipap and has air hunger when it is turned off. Of note, she had a VZV vaccine on or about 9/1/20. 9/16/2020. Unfortunate 78-year-old lady with morbid obesity, chronic obstructive pulmonary disease, recently vaccinated for varicella zoster virus who developed a rapidly progressive Guillain-Barre on 09/10. Currently intubated. She is status post a completed dose of IVIG. NIF remains low and she has no muscular function in her lower extremities. Neurology is recommending pain control for the neuropathy and no further therapies for the Galbraith. Time and physical therapy may allow for recovery. She will likely need a protracted vent wean. We will put her on 10/5 pressure support today. She also need protracted rehab but she is now bedbound until she potentially regains functional status. We will therefore try to have her placed in LTAC to assist with both the ventilator weaning and rehabilitation from yellow-gray syndrome. Regarding other active medical issues she is still slightly hypervolemic we will continue Lasix and Diamox. Regarding her A. fib this is well controlled with her current dose of diltiazem. She is on anticoagulation for this. Regarding her pneumonia she is completed a course of antibiotics. She is still has MRSA in his sputum culture. This may be colonized endotracheal tubes there is no convincing signs of bacterial pneumonia on chest x-ray imaging or clinical exam (no white count no fever etc.). We will continue to monitor and have low threshold to institute anti-MRSA coverage should she develop worsened respiratory failure but for now she is off antibiotics.
Moderna COVID-19 Vaccine EUA: I developed sudden onset atrial fibrillation 11 days after injection number 1. (shortness of breath, rapid heart rate, palpitations)
Sore arm, mild itching, both occurring at the injection site/Mild soreness at injection site (similar to flu shot), mild itching - nothing substantial; Sore arm, mild itching, both occurring at the injection site/Mild soreness at injection site (similar to flu shot), mild itching - nothing substantial; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, on 02Apr2021 09:30 AM (at the age of 50-year-old), in left arm as dose 1, single for COVID-19 immunization and also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, on 23Apr2021 09:45 AM (at the age of 50-year-old), in left arm as dose 2, single for COVID-19 immunization. Medical history included Colitis ulcerative from an unknown date and unknown if ongoing. Allergies to medications, food, or other products reported as none known. Concomitant medications included balsalazide taken for an unspecified indication, start and stop date were not reported and tylenol taken for an unspecified indication, on day of vaccination only. Patient did not taken any other vaccine in four weeks. Patient had not diagnosed with COVID-19 Prior to vaccination and patient had not been tested for COVID-19 Since the vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 the patient experienced sore arm, mild itching, both occurring at the injection site/mild soreness at injection site (similar to flu shot), mild itching - nothing substantial. Same events occurred after prime and boost and with roughly same time course. Soreness first apparent about 5 hrs post-injection reaching peak about 10 hrs post-injection, persisted for about 2.5 days. Itching first noticed approx. 24 hrs post-injection, disappeared after about 2.5 days. Patient was taken 3 max strength Tylenol/day (spaced morning, afternoon, night) on day of and day after each injection to mitigate side effects. Mild soreness at injection site (similar to flu shot), mild itching nothing substantial, disappeared after 2-3 days, patient took tylenol max strength (1 pill before inoculation, 1 pill in afternoon, 1 pill in evening) to help reduce any potential side effects. Treatment was not taken for the reported adverse events. The clinical outcome of event was recovered on unspecified date 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse referring to a 8 weeks old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 16-MAY-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, (lot# N032566, expiration date 01-MAY-2019), for prophylaxis (strength, dose, frequency were not reported). The temperature excursion was of 9 Centigrade degrees (degrees C) to 25 degrees C (10.2 degrees C), during 52 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA008127.
About 2.5 hours after administration patient complained of extreme pain in left arm, without decrease mobility. Patient was advised to see medical attention due to extreme pain . Patient came by later date to notify that injection may have been too high on shoulder. Patient's arm is getting much better but still a bit stiff and still aching.
Fully Vaccinated with Covid19 Moderna EUA -3/19/21-4/17/21-
Sore arm of prolonged duration progressing to decreased mobility of shoulder. No imporvement with PT.  X Ray negative Dx tendonosis by MRI 2 months after injection.
Patient experienced headaches early morning following the day after flu shot and shingles vaccine (approximately 6am). Patient subsequently took Tylenol at 7am, then broke out in a sweat an hour later. Patient also reported nausea and dry heaves, and has been taking ondansetron.
Foster-mother reports that approx. 13 hours after receiving vaccines that the patient developed a fever of 105.  She was evaluated by the ER, No treatment other than Tylenol.  8/13/09 Hospital records received DOS 8/5/09 to 8/6/09. Assessment: Nonepileptic spells, developmental delay, tubular sclerosis.  Child was observed to have 5 clusters or bilateral arm extension, each lasting a second with change in facial demeanor and post event fussiness, one time per day. Events have continued a clusters of head dropping and arm extension spells. Patient was admitted with tubular sclerosis and mild developmental delay and concerns regarding head drop, arm extension, and possible infantile spasms.  2 spells were detected and established not to be epileptic seizures.  8/13/09 ICD-9 Codes received: 784.99 Symptoms involving head and neck,  780.39 Convulsions,  759.5 Tuberous sclerosis,  783.40 Lack of normal physiological development unspecified.
Monovalent vaccine incorrectly administered for a booster dose (if bivalent booster indicated).
At 2230 on the night of the reaction I started to have heart palpitations. These palpitations lasted for a total of 17-18 hours.
This patient's arm developed a rash behind the arm (erythematous papular rash), warm to the touch. The patient was prescribed Hydrocortisone cream, and Benadryl.
Dizzy and vertigo - horrible vertigo for one solid night and then dizzy spells - I've had four since the first one that happened about 10 days or so after my second dose of the vaccination. I've also had three episodes of feeling faint that lasted about one second each. The dizzy spells seem to be getting better...not as severe.
The patient reported to me today that she believes that the Moderna vaccine series that she received caused her to gain 20 lbs over a short amount of time and she also had severe inflammation in her legs.  She also stated that her thyroid medication dosage had to be increased, her kidney function has been low and her lipid levels have increased all in the following months after her covid vaccine series.  She reported that she read a study that links the moderna vaccine with weight gain and months later believes that it was the cause of her medical issues described.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. An infant patient of an unspecified age (below 2 year-old), race, ethnicity and gender received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunisation. The patient was fully vaccinated (unspecified number of vaccine doses). The patient medical history and concomitant medications were not reported. No underlying health conditions were present. The patient experienced recurrent pneumonia on an unspecified date. When antibody titers were tested, 6-7 of titers were below normal. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Linked Report(s) : US-PFIZER INC-2017514647 same reporter/suspect product/event, different patient
Two falls after receiving second dose of vaccine; Having jelly legs after receiving second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Two falls after receiving second dose of vaccine) and MUSCULAR WEAKNESS (Having jelly legs after receiving second dose of vaccine) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM, METOPROLOL, PARACETAMOL (TYLENOL), WARFARIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FALL (Two falls after receiving second dose of vaccine) and MUSCULAR WEAKNESS (Having jelly legs after receiving second dose of vaccine). At the time of the report, FALL (Two falls after receiving second dose of vaccine) and MUSCULAR WEAKNESS (Having jelly legs after receiving second dose of vaccine) outcome was unknown. Not Provided          No treatment drugs were reported.
Pain at injection site (intense pain/soreness in left deltoid for over 24 hours after shot)
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006643.
Initial report received from a healthcare professional on 20 November 2013. A patient whose gender, age, medical history and concomitant medications were not reported, had received a dose of ACTHIB vaccine, a dose of Pneumococcal vaccine from Wyeth batch number: G47423 and a dose of PEDIARIX vaccine from GlaxoSmithKline batch number: 5GS7L all vaccines on 26 August 2013 in the right thigh (route and dose number vaccines was not reported). On an unspecified date, the patient had fever, only once. The corrective treatments and laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by sender is none. Additional information received on 06-Dec-2013: details were provided for immunization as follows. ACTHIB, lot # UH685AA was given on 4/18/13. ACTHIB, lot # UH738AA was given on 6/24/13. ACTHIB, lot # UH811AA was given on 8/26/13. Follow-up information received from healthcare professional on 16 January 2014. No new information was provided by reporter. Follow up information received from the healthcare professional on 28 January 2014. A 11-month-old female patient (birth weight was 3.3339 kg) had received a dose of ACTHIB (lot number was amended to UH811AA-UH782AB, previously was reported as: UH11AA-UH782AB), a dose of Pneumococcal vaccine and a dose of PEDIARIX vaccine on 26 August 2013. The number of brothers and sisters was reported as 3. It was reported that the patient and her brother and sister had no adverse event following prior vaccination. The vaccine was purchased with private funds and was vaccinated at private doctor's office or hospital. The patient did not receive any concomitant medications. The patient illness at time of vaccination was not reported and had no pre-existing physician diagnosed allergies, birth defects and medical conditions. No laboratory investigations were done. The patient was recovered on an unspecified date.
Flushed with nausea, increased blood pressure, tingling in arm & feet; bp decreased, o2 levels normal, ambulance dispatched & patient transported to ER for further exam
under arm started to burn, went and looked and glands had swollen up to golf ball size; under arm started to burn; Pain in joints; headache on right side; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration administered in right arm on 02Feb2021 11:00 as a single dose for covid-19 immunization. Medical history included asthma, gluten allergy, fructose allergy, lactose allergy. Concomitant medications included calcium, tea, green, diindolylmethane (DIM), Asthma inhaler and Vit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unknown date as a single dose for covid-19 immunization. On 03Feb2021, the patient experienced pain in joints and headache on right side. In the evening at about 5:30, under arm started to burn, and glands had swollen up to golf ball size. No treatment was received for the adverse events. Seriousness of the events was assessed as non-serious by reporter. The outcome of the events was resolving.  Follow-up attempts have been completed and no further information is expected.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
After the 1st dose on Dec 7, 2021 constant aching in every finger and toe started. Two days after the second shot, got noticeably worse. The shoulder, elbow and knee pain remained the same. Fingers and toes have very low tolerance to cold. Just a few minutes exposure results in excruciating pain. Occasionally have shooting pains through forearms and lower legs. Taking  2 aspirin and 2 Advil every day to ease the pain.
The night after I received my booster shot, I woke up achy and walked to get ibuprofen. Before I could make it to the medicine cabinet I threw up and began getting extremely light headed. I sat on the toilet and immediately began losing sight as I was about to pass out. I laid on the bathroom floor to avoid injury and could not control my bowels at all. After completing bowel movements on the floor I was able to get up, clean off, and go back to bed. Full body chills took over immediately and I began to develop a fever reaching 102 F. After a day of battling these side effects, I thought I was in the clear, aside from a rash at the vaccination site that lasted a few days. 11 days after receiving the Moderna booster I broke out in a random rash that began at my neck and appeared and disappeared all over my body. My eyes began to swell shut on the third day with the rash. I went to a doctor for steroid treatment and I have developed Dermatographia. I am not as itchy now as I was for the first 5 days of the rash, however anything that grazes my skin leaves a bright red scar that grows quickly and raised across the affected area. It tends to last about 30 minutes to an hour before totally disappearing and potentially resurfacing elsewhere.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna; vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 17:15 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 03Feb2021 as dose 1, single (Lot number: 031L20A), in left arm, on 03Mar2021 as dose 2, single (Lot number: 002a21a), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: 014f21a), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: 065k21a), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE BENAZEPRIL, start date: 01Jun2018, stop date: 29Sep2022; LEVOTHYROXIN, start date: 01May2017, stop date: 29Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022 at 17:15, outcome "unknown", described as "vaccine brand other: Moderna; vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Family stated that pt had a "seizure" the afternoon, post vax, and went to ER. After multiple attempts to contact father for records release to get copy of ER visit, there has been no response.