chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED on 1/5/2022 with progressively worsening left lower extremity weakness and numbness, later affecting the right lower extremity and bilateral upper extremities, with hypertension, tachycardia, and hypoxia. He was placed on supplemental oxygen, later needing mechanical ventilation due to respiratory dysautonomia, for 2-3 days, with worsening strength in all 4 extremities, decreased proprioception in lower extremities, and diminished DTRs throughout. He was treated with antihypertensives, antibiotics for aspiration pneumonitis with Zosyn, and a five day course of IVIG for Guillain Barre Syndrome, which was confirmed with LP with normal cell count and elevated CSF protein levels. Ongoing management of Guillain Barre Syndrome, with daily neurological evaluations.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2020 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Treatment with Paxloid from 18Sep2022 to 22Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Spot in right eye vision would not go away, saw ophthalmologist and diagnosed with clot in retinal capillary.
Patient got the Pfizer Vaccination on October 1st didn't come back for the second shot until 1/24/22
Could not feel the Legs after 2nd shot; Feet hurt constantly after 2nd shot; "My legs get out from under me" after 2nd shot; Muscle Weakness after 2nd shot; Fatigue for 20 hours after 2nd shot; First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot), MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot) and FATIGUE (Fatigue for 20 hours after 2nd shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot), MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot), FATIGUE (Fatigue for 20 hours after 2nd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021) outcome was unknown, MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot) had not resolved and FATIGUE (Fatigue for 20 hours after 2nd shot) had resolved.            Concomitant medications was not provided by the reporter. The patient had no  medical history of any disease and was healthy prior to vaccination.  After the second dose vaccination patient experienced fatigue for 20 hours. The patient received a Booster dose of Pfizer COVID-19 vaccine on 21-Feb-2022. It was reported that the muscle weakness did not get any better or worst after the Pfizer dose.   The Patient was prescribed with unknown pain medication which did not work and took ibuprofen on her own.
Patient reported that her left arm was "swollen (the size of a softball), red, and hot."
DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating.  On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Fever 103 (rectal), irritable, redness. Tylenol given.
On 04/17/2021, I started developing severe nausea. I ran to the restroom and ended up vomiting non-stop/dry heaving throughout the day. I would try to drink a few sips of water. Also, I took Benadryl to see if that would help. I called my PCP (on Saturday) but couldn't get through and LVM. So, I called on a nurses line and they recommended going to Urgent Care if it gets worse. Luckily, I was able to continue the fluids and resting throughout the day and I avoided urgent care. By the next day, I was feeling better. I notified my PCP who recommended a visit with an allergist. I saw the allergist via telehealth and they said even though it was unpleasant, they didn't consider it a severe side effect to the point where I shouldn't get vaccinated. They told me to be hydrated when I got vaccinated and to take Tylenol as soon as the symptoms started.
Sore arm; Feels that did not received the full vaccine; The syringe did not enter to the muscle, but entered to the fat; A spontaneous report, was received from a consumer (patient), female adult patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced sore arm (pain in extremity), feels that did not received the full vaccine (underdose), and the syringe did not enter to the muscle, but entered to the fat (incorrect route of product administration). The patient's medical history was not reported. Concomitant medications were not reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number: 029L20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 15 Feb 2021, prior to the onset of the events, the patient received their second planned doses of mRNA-1273 (lot number: 004M20A), into the arm for the prophylaxis of COVID-19 infection.  On an unknown date in Feb 2021, the patient experienced sore arm, and feels that did not received the full vaccine. The patient noticed that the nurse who administered her the vaccine squeezed the arm before giving the vaccine, and it seems that the syringe did not enter to the muscle but entered to the fat. The patient states that, between the two doses, took an antibody test, with a negative result. The patient inquires if she can take another antibody test and if she can receive a third dose to ensure more protection. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the event, sore arm was reported as unknown, that of events feels that did not received the full vaccine, the syringe did not enter to the muscle, but entered to the fat, were considered as recovered on an unknown date in Feb 2021.; Reporter's Comments: This case concerns a female who had nonserious unexpected events of incorrect route of product administration for the second dose of mRNA-1273 (lot # 029L20A) with associated adverse events of underdose and pain in extremity. The adverse events occurred with unknown latency. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, Myalgia, Arthralgia & Fever Narrative:  Had COVID disease in Sept 2020 2nd dose: 19th@ 1230 Finished shift @ 1600. Middle of night woke up. Husband said she was hot. Had chills 0200 Chills and fever. Minimal with Tylenol #1 Back/kidney pain. Went to doctor -u/s & UA both normal. Chills, body aches, worse, kidney pain less. Improving. Rotating Ibu and Tylenol. This morning imrpvoed - still pain in back & chills. Some better with medication. Had pos COVID in Sept.
p/vax thrush; severe resistance to po feeding for wk; dec po intake; inc bowel sounds; spit up; tenderness/mass; happy until trying to feed, very unhappy then; thrush gone;
pt recvd vax 10MAY95 & 11JUL95 pt devel checkenpox reportedly confirmed by a physician;No further details were provided;
No known effect to baby since it is not due for a few more months. I am only aware of the hearing loss I experienced as the pregnant mother I?ve now had two separate bouts of hearing loss. The first started 5 days after the first vaccine and lasted around 36 hours. The second was almost two weeks after that and also lasted around 36 hours. Both times I felt a lot of pressure in my ears and had muffled hearing. I subsequently made an appointment with an ENT that alerted me this could be a vaccine side effect. I have not had my second dose of the vaccine yet.
The patient was administered a dose 1 month too early per CDC age regulations for 2nd booster dose.
Covid bivalent booster administered out of vial that had been opened more than 24 hours. NO adverse events noted at this time. Following up with CDC and manufacturer for further dosing guidelines.
Patient is reporting that they have felt an overall fatigue, and tiredness throughout the day today.  Patient also report experiencing diarrhea this morning, but they indicated that that has subsided throughout the afternoon. The patient informed me that they felt perfectly fine after receiving the shot as well as the following day.
Fever to 40.3, generalized tonic clonic seizure lasting approx 2 minutes, vomiting x 5.
PATIENT STATED SHE USUALLY EXPERIENCES REDNESS AND SWELLING AFTER THE FLU VACCINE IS ADMINISTERED. THIS YEAR, SHE REPORTED ON 1/21/2014, IN PERSON, THAT THE REDNESS AND SWELLING ARE STILL PRESENT. SHE ALSO SAID THE AREA IS HARD AND WARM TO THE TOUCH. SHE DID NOT SEEK ANY MEDICAL ATTENTION BUT I ADVISED HER TO SCHEDULE AN APPT TO BE SEEN.SHE IS CURRENTLY APPLYING ICE PACKS TO RELIEVE SOME OF THE SWELLING. SINCE IT HAS BEEN OVER A MONTH SINCE HER VACCINE, I ENCOURAGED HER TO BE SEEN.
drop in platelets after pfizer vaccination; shortness of breath at rest; This is a spontaneous report from a contactable consumer reporting same events under the same suspect products for 13 patients. This reporter reported for one of the 13 patients that a patient of an unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for COVID-19 immunization. Patient medical history included cough from Feb2020 to Feb2020. Patient concomitant medications were not reported. The patient experienced drop in platelets after pfizer vaccination, shortness of breath at rest. The events were assessed as non-serious. The outcome of the event drop in platelets after Pfizer vaccination was unknown whereas the outcome of the event shortness of breath at rest was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB.  Had ST elevation on EKG in ER, taken to Cath Lab- no intervention done.  D/C home 12/22/20.  Previous Hx of COVID per patient
Pt received Pfizer vaccines on 04/20/21, 05/15/21, and 11/05/21. Pt presented to the ED with complaints of confusion, fever, and hypoxia. Pt was found to be COVID positive.
Slight soreness in arm and slight headache day of vaccination into next day.  24 hours after vaccine on 8/14 experienced headache, fever, chills, body aches, extreme fatigue, excessive thirst and sweats for about 12 hours.  8/15 continued with fatigue.
Patient with history of fainting fainted 2 minutes after receiving the J&J COVID vaccine while still siting on the vaccination chair. Patient was carefully lowed to the floor. She regained consciousness while reached floor. She denies any medical history. Her last annual check up was Jan, 2021. Her VS was checked. Her initial VS at 12:49: BP 114/68; P 68, Res 16; O2 sat 100%. She was given water and snack and she rested on the floor mat  for approx 30 mins.  Her VS has been checked several times and has been stable. She left the vaccination site symptom free.
REDNESS ITCHING TENDERNESS MILD RASH MEASURING 107MM X 75MM.
The day after the shot (Saturday), I started getting the chills and I was fatigued.  My temp topped at 102.5.  My arm at the injection site was very sore, hot and hard and had a rash about 3" in diameter. My fever came and went all day and into Sunday morning, then it seems to subside, though I was still tired.  Monday, I thought I was fine and resumed my normal activity of gardening.  At about 4pm, I got the chills again and had a low grade fever, 98.5.  (I usually run about 96.9).  Besides this, my arm was hot and the rash went down my arm.  It was about 6" long and 4" wide.  I marked the borders to make sure it didn't spread any more.  This morning, Tuesday, The rash is still within the border and not as red, but still hot and itchy.  I am also fatigued today.
The event came out of nowhere.  I had excruciating nerve pain in my lower back.  It started in my lower back and ran down my right leg to my foot.  However the pain was in both legs, terrible cramping and tingling in both my feet.  I could barely walk and  I was bent over in pain. There was also terible cramping in my calves on both legs.   I went to urgent care for it and they took Xrays. I was told to alternate icing and heat on my back and take tylenol.  It did not work.  I then went to my Primary Care Physician and she prescribed physical therapy, tylenol and Gabapentin (300 mg).  The physical therapy made it worse and the pain was still excruciating.  I went back to my PCP and she upped my Gabapentin dosage and referred me to a Specialist.  I went to see her and long story short I had 2 epidural steriod injections, spaced about 3 weeks apart.  Now I have only tingling in my feet.  I am going to physical therapy presently.
Information has been received for a physician assistant concerning a 8 year old male patient who on 11-SEP-2001, was vaccinated with VARIVAX (Merck).  Concomitant therapy included DIGITEK.   The physician assistant reported that on 02-MAY-2008, the patient developed herpes ZOSTER.  The patient had a rash under his left eye, which had happened 4 times.  His temperature was 97.7 F.  The patient did not have a rash at the site of the injection post-vaccination.  The patient had no recent exposure to chickenpox and there was no recent exposure to shingles.  At the time of the report, the patient had recovered.  The patient sought medical attention, was seen by the physician.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if is associated with the wild-type (WT) VZV strain or with the MERCK vaccine VZV strain.  The sample of the lesion was collected on 10-JUL-2008.  The sample was taken from dry - crusted vesicular lesions.  The results showed no amplified VZN DNA.  The interpretation indicated inadequate lesion, negative for B-globin, no strain I.D.  No further information is available.
within 6 hrs, baseball size area of redness, warmth and hard area of swelling with itching at injection site- swelling extended down to elbow and including entire upper arm lasting 3 days.  12-14 hrs after injection nausea, severe headache and fever with profound nausea - vomiting shortly thereafter. Temp of 100.2 at that time- may have been higher but wasn't taken immediately.  Dizziness, nausea, muscle aches, and severe headache for at least 36 hrs with intermittent heart palpitations.  Symptoms slowly resolved after 3-4 days.
This case was reported by a healthcare professional and by a healthcare professional via a sales representative and described the occurrence of septic shoulder in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 5 February 2012 at 14:30 or 15:00 the subject received a dose of BOOSTRIX (.5 ml, shoulder injection site) and experienced wrong injection technique. One of the reporting healthcare professionals believed that injection technique played a role in the events. He reported that the vaccine may have been administered too closed to the shoulder joint. On 12 February 2012, 7 days after vaccination with BOOSTRIX, the subject experienced septic shoulder ("developed sepsis in the shoulder joint of the arm in which the vaccine was administered") and in February 2012, the subject experienced abscess at injection site on shoulder. The subject presented to the emergency room "last night" (12 February 2012) and was hospitalized overnight. The subject was scheduled for surgery to remove abscess. This case was associated with a pharmaceutical product complaint. One of the healthcare professionals reported that the vaccine lot had been used with no other complaints since December 2011 and the he was 99 percent sure there was not a problem with the vaccine, but was waiting on the vaccine culture results. Another healthcare professional reported via the sales representative that facility put a temporary hold on this lot of vaccine and was having the lot cultured because they think there maybe something wrong with the product. The subject was hospitalised and the healthcare professionals considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Developed circular lesion on right cheek immediately after receiving Prevnar. Size larger than a quarter, initially red, then turned purple. Duration 1 week. No pain.  Resolved by itself.  Discussed with MD at 6 month visit.
Physician spouse brought dose of Fluzone home from the clinic he worked at and administered to left deltoid about 7:30 pm. Shortly afterwards I noticed my lips burning which I did not then attribute to the vaccine.  By the next morning I had such severe facial angioedema as to be unrecognizeable.  Over the next 24 hours I developed red hot swollen wrists and w/in 48 hours I developed urticaria and erythema multiforme and painful swollen knees. On the presumption of serum sickness I  started myself on prednisone 60 mg. (I am also a physician)  Symptoms started to resolve the next day and prednisone was discontinued on the 4th or 5th day due to gastritis.  While joint symptoms and angioedema resolved completely, I continued to experience evanescent urticarial eruptions mostly on my upper extremities and posterior neck, almost nightly for the past four weeks, responsive to diphenhydramine 25-50 mg.  Last night while sitting quietly and reading I experienced worse than usual hives on my left shoulder and then, abrupt onset of excrutiating pain in my left shoulder in an anterolateral distribution.  Any motion of the UE intensifies the pain to the extent that I cannot actively abduct or elevate the arm. I have no history of problems with this shoulder, no trauma or overuse and there are no symptoms of cervical radiculopathy.  I believe I now have brachial neuritis which apparently can develop as a post vaccine reaction.  The recurring hives makes me suspicious that there is an immunologic basis for this presentation.  I am awaiting evaluation by my personal physician later today.
Child struggled during vaccine administration Tdap squirted on (R) arm. Child had immediate rash, swelling to arm, ice pack placed, Benadryl given. Pt stable.
vaccine is too painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. Reporter stated that the vaccine was too painful. Additional supportive information: Follow-up would not possible, as no contact details were available.
Grandma noticed red & flushed face at first. Then mom noted a large hive on left arm. Within min patient began to be covered in red hive warm to touch bumps. Hives on face came last. C/o red & swollen eyelids, c/o green drainage from eyes over the next 2 days. Started BENADRYL q6hr x24 hours. Rash started to fade late 5/26/12 Saturday. No resp problems. Called Dr. on call has instructed to give BENADRYL.
Nearly immediate extreme dizziness, blurred vision like going to faint, rapid heart, profusely sweating