chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seen on 11/9/02 at doctor's urgent care and given Benadryl per mom-seen in PCP office on 11/11/02: temp of 102-104, vomited on Saturday, large local reaction per MD.
Initially had arm pain and body aches.  These went away but now have constant ringing in the ears which started sometime within the first two days of getting the second vaccination.
Onset on 4/2/2021 began with a salmon colored spotted rash on the outside of both thighs and a sore throat. Morning on 4/3/21 Patient went to urgent care. Diagnosed with rash and provide cream for rash. Muscle and joint pain followed on the evening of 4/3/21. On 4/6/21 joint redness and swelling was severe and patient was unable to stand or walk without assistance. Patient went to urgent care and was diagnosed with upper respiratory infection. The evening of 4/6/2021, patient experienced high fevers 103+. The fevers would subside with Tylenol, but would return when the Tylenol's effects would wear off. On 4/9/2021 patient was taken to the emergency department and admitted. Patient was ultimately diagnosed with Adult Onset Still's Disease.
Patient called stating that the vaccination had caused unusual swelling and worsening of her asthma symptoms. These are the same symptoms that she had experienced with last years high dose vaccine. The issues were resolved using her VENTOLIN HFA inhaler and did not return.
flu; Initial information received on 28-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Last time patient had the flu was the last time patient got a flu shot. Been over 10 years, no shot, no flu Imagine.  It was unknown if there were lab data/results available.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on batch number for this case.
On the 8th day a rash developed about 10 cm in diameter  around the injection site.  Extreme itching. Area warm to the touch.
My tendons are loose; Tendon issues/ arch in her right foot has dropped; Congestion; Can I still get the 2nd dose; Pain at the injection site; Redness at the injection site; The bones in my right foot started popping; The bones in my neck started popping /  It would pop with movement; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Charcot-Marie-Tooth disease (The patient's left foot has a brace on it) and Neuropathy since an unknown date. Concurrent medical conditions included Diabetes and Smoker.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (The bones in my right foot started popping), MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping /  It would pop with movement), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose). On 21-May-2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), TENDON LAXITY (My tendons are loose) and TENDON DISORDER (Tendon issues/ arch in her right foot has dropped). On 06-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose) had resolved. At the time of the report, PULMONARY CONGESTION (Congestion), TENDON LAXITY (My tendons are loose), TENDON DISORDER (Tendon issues/ arch in her right foot has dropped), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and LIMB DISCOMFORT (The bones in my right foot started popping) and MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping /  It would pop with movement) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported/ unknown.  Treatment included Vancomycin and Cortisone epidural.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-162325 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-162325:Crosslink
A non-serious report of administration of expired FluMist has been received from a nurse concerning a 28-month-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006659; MEDI-0006684.
Extreme Vomiting for 12 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 09:00 (Lot number: ER8732) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1. Extreme Diarrhea for 12 hours. Somewhere between day 5-7., lot number= EN6207, Administration time=09:00 AM, Vaccine location=Left arm), administration date: 18Mar2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Extreme Diarrhea for 12 hours".  The following information was reported: VOMITING (non-serious) with onset 12Apr2021 19:00, outcome "recovering", described as "Extreme Vomiting for 12 hours". Therapeutic measures were not taken as a result of vomiting.  Additional information: The patient had not received any other vaccine within 4 weeks. The patient had no known allergies. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; devel redness & swelling at inject site; Ice applied at rxn site & all sxs resolved;
rash just below injection site; chest tightness; This case was reported by a consumer via call center representative and described the occurrence of localised rash in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On 18th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced localised rash and chest tightness. The patient was treated with methylprednisolone. On an unknown date, the outcome of the localised rash was unknown and the outcome of the chest tightness was recovered/resolved.   It was unknown if the reporter considered the localised rash and chest tightness to be related to Shingrix.  Additional case details were reported as follows: The patient received first dose of Shingrix and experienced rash just below the injection site, in an area about 3.5 by 3.0 inches in size and some chest tightness. The patient did not consent to follow up.
Pre-syncopal event - pallor,  sweating, wooziness - swaying from side to side.  Patient reported "tunnel" and "black" vision with the event.  On arrival, I noted the patient looked pale, and had sweating along his forehead, and appeared woozy - he was swaying from side to side slightly. I asked him to stand slowly, then to take a few steps slowly, then to step up on to the bed slowly, then to scoot back and lie down at a 30 degree angle (with 30 - 60 second pause with each new action). I applied a cold compress to the back of his neck (ice pack) and wet cool paper towels to his forehead and asked him to lie still. I stayed and observed for an additional 5 minutes (two BP/pulse measurements) and he stated he was feeling better. He was able to drink a little water and a little juice during this time. His color returned to baseline and the sweating resolved. He stated that he had no further vision changes - it was back to normal. He was conversing with me normally, answering questions appropriately; at this time it had been 15 minutes since the vaccine was given. I asked the patient and Mom to stay an additional 10 minutes for further monitoring, and they agreed. At the end of 25 minutes, he was able to sit up slowly, then stand slowly, then take a few steps (30 seconds between each new activity) without any return of pre-syncopal symptoms. I advised Mom to notify medical personnel that he has a h/o presyncope/syncope with vaccines in the future so we can administer the vaccines with him lying at a propped angle in the bed (to prevent falls).
SWELLING AT SITE OF INJECTION AND HEADACHES THE DAY AFTER ADMINISTRATION. SWELLING AND HEADACHES SUBSIDED 2/1/16.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2015, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Acute stroke 2 days after receiving vaccine.  Second stroke 7 days after that despite being started on aspirin and statin
Patient complained of body aches, chills, and nausea occuring a few days after the vaccine was administered.
post-herpetic neuralgia; skin lesions developed on his head and forehead; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not reported. In or around February 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) being administered, the pt developed skin lesions on his head and forehead, and this resulted in post-herpetic neuralgia in his upper body, particularly the shoulders, that also persisted to the present. The pt first learned of the link between zoster vaccine live (ZOSTAVAX) and injuries such those from which he (also reported as she, conflicting information) suffered, on or about 22-DEC-2018, when a friend shared information found on website. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered as related.   Skin lesions and post-herpetic neuralgia were considered as disabling.
HYPOTENSION 2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Received above vaccines on 4/6/12. Infant holding head & seen in peds on 4/9/12. Peds said infant was WNLS. Rash developed on 4/11/12. Temperature from 4/6/12 - 4/9/12. Infant extremely irritable. Infant had another fever & rash - seen in peds on 4/19/12 - diagnosis - viral infection.
Child broke out with hives on arms, and from groin down. Benadryl given my mom 2 times. Hives gone next AM.
Headache, chills, all over body aches. Began around 8PM 1-1 and as of 7:48 AM on January 2, effects still occurring.
p/vax lt leg red & swollen all of thigh;if just touch foot pt cries;T97.3, T98;
This spontaneous report was received from an office manager via a company representative referring to a 65 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 01-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # N025384 with expiration date 19-APR-2019), for prophylaxis (dose and route of administration were not reported). It was stated that no other vaccine was administered to the patient on the same date. On 08-MAR-2018, the patient went to the physician's office with swelling and pain at the injection site. On the same date, the patient was diagnosed with cellulitis (injection site cellulitis). At the time of reporting, the outcome of the event was unknown. The causality assessment between injection site cellulitis and PNEUMOVAX 23 was not provided.
Patient had a headache, red and swollen injection site, and lethargy beginning the evening of vaccination.
A Pfizer Bivalent vaccine was already administered to this individual on 9/22/22. at our office. We administered an additional pfizer bivalent vaccine on 4/28/23 by mistake. The individual who received the vaccines has not had any health issues.
Per parent child had staring episode several hours after vaccine, lasting a few seconds. Taken to ER for evaluation.
My daughter has red facial breakout that is tender to the touch and continues to spread. It is now covering her entire face to the hairline and going under the chin. She also has red breakout on the injection site.
After getting her COVID vaccine, patient complained of feeling lightheaded.  VSS.  She then reported tightening to throat and was given 0.3 mg epinephrine.  Ambulance called.  She reported ease in breathing after epinephrine.  She was monitored until ambulance arrived to transport her to the Emergency Department. She was stable, alert oriented and communicating when ambulance arrived.
On September 24 about 2 hours after the shot, I just wasn?t feeling well - no appetite and a bit nauseous. About 10 PM of the injection day I began to shiver although I wasn?t cold. My teeth were shattering and I couldn?t stop shaking. I woke my husband up worried that I was having an adverse reaction. I took Benedryl and Tylenol and around 11:00 PM, the shaking subsided. Then I began to run a fever for the next 32 or so hours. After the fever broke, I finally felt better on the28th.
Developed a red rash to injection site that soon spread across upper back and neck.  No shortness of breath. No difficulty breathing. No loss of consciousness.  10:25 pm - Epi pen 0.3 mg IM given x 1 . Benadryl 50 mg x 1 dose given.  EMS called and arrived within 4 minutes. Patient transported to local ER for further evaluation and treatment.
Numbness on left side of face lasting from 3pm to after midnight on 3/8/21.  It subsided on 3/9/21 during the day, but again felt numbness on left side of face at 10:00pm on 3/9/21.  Continue to feel nausea, no appetite, and extreme fatigue.
PT CALLED COMPLAINING OF EXCRUCIATING PAIN THROUGHOUT HER BODY FROM HER HEAD TO THE BOTTOM OF HER FEET REQUIRING HER TO STAY IN BED FOR THE LAST 5 DAYS
02/08/22 presents to ED for "Abnormal Labs". PMHx of "hypertension, BPH, chronic anemia"
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 16Jan2021 21:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Jan2021, the patient experienced right side of her eye was completely blood shot. This morning 17Jan2021 there seems to be a raised vessel which is dark red in the same eye. The patient was not in pain, nothing scratching. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt. had a reaction to COVID-19 vaccine dose #2.  Pt. states symptoms of having headache, blurred vision and dizziness, also states having blood work done prior to coming to receive COVID-19 vaccine.  No meal consumed prior to vaccination.  Pt. verbalized having a reaction to flu vaccine, having symptoms of being ill with nausea and vomiting.  Pt. has current allergies to codeine, latex and shellfish.  No hospital care provided as per patient request.  Pt. boyfriend will provide transportation as requested by EMs.  Pt. verbalizes that she feels better and wants to go home.  No hospital care provided.  VS 129/94, 100% O2Sat, 80 P, 174/84, 91P, 98 O2Sat.
Pt woke up with blister on palm of her hand, & 2 spots on back. Dermatologist diagnosed it as chicken pox. Pt had chickenpox at 7 years of age.
DROP IN HEMOGLOBIN; DROP IN HEMOGLOBIN AND WHITE AND RED BLOOD CELL COUNTS; DROP IN HEMOGLOBIN AND WHITE AND RED BLOOD CELL COUNTS; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EN6202), via an unspecified route of administration in left arm on 26Feb2021 at 15:00 (at the age of 53-year-old) at single dose for COVID-19 immunisation. Medical history included Crohn's. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, the patient experienced drop in hemoglobin, white blood cell and red blood cell counts. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events included iron infusion. The clinical outcome of the events was recovering. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207) via an unspecified route of administration in left arm on 22Mar2021 at 11:00 at single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: lab data added.
Patient developed chills, nausea, headache, body aches, loss of appetite. She went to the emergency room and received Benadryl and a bolus of normal saline,  She is feeling back to her baseline today,
PATIENT HAD RECEIVED PFIZER COVID VACCINES, Dose 1 date: 01/12/2021, Dose 2 date: 02/02/2021. PATIENT TESTED POSITIVE.
Pt given flu vaccine on 10/4. Pt reached out to clinic on 10/26 stating shoulder was still sore with certain movements. Pt was seen virtually by one of our physicians and then followed up with our physical therapist.