chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There was no seriousness criteria reported in this case. Based upon appropriate medical judgement the reported event was considered serious: medically significant event (OMIC). From initial information received on 6/28/04 from a physician regarding an adverse event occurring in the he USA, it was reported that a 35 year old female patient received a TD ADS ADULT vaccination for wound management after a laceration, lot number U1185AA, administered IM in the right deltoid, on 6/21/04. on 6/25/04, the patient developed a fever of 101 degrees, trismus, polyarthralgia, body tremors and generalized malaise. The patient was evaluated on 6/28/04 and was diagnosed with encephalomyelopathy. The recovery status of the patient was reported as unknown. From phone call made to the reporter on 6/29/04, it was confirmed that the preliminary diagnosis is encephalomyelopathy. The MRI was reported normal. This patient was not admitted to the hospital. It was the feeling of the emergency room doctor that her symptoms may have been psychogenic. She was treated with steroids. Recovery status is unknown at this time. Patient reported that her mother told her when she was age 10 years old she was unable to walk after a Td shot. Also, the patient had a 4cm laceration of her right arm. From additional information received on 09Aug04, it was reported that no additional information is available at this time. Per the reporter, the pt was lost to follow up. No further information regarding the pt's recovery status was reported. Further information is not anticipated, this case is considered closed.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent history was reported. On an unknown date, the patients were vaccinated with ROTATEQ SUSPENSION 2. On an unknown date, patients were either regurgitated or vomited after receiving a dose of ROTAROTATEQ and may not have received full dose. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the two reports from the same source. Additional information has been requested.
not being able to breathe; Runny nose; congestion; fever; headache; feeling of being sick; flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp.   A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included vitiligo. There were no concomitant medications. 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 experienced runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms on an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on an unknown date. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms (Pain killers, flu medicine). Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
At time of vaccination, it felt like she had thrown a dart into my upper arm and shoulder that was loaded with all the vaccine. The next day my arm was sore but with each day it kept getting worse not better. I called my doctor, and she suggested 600mg Ibuprofen 3-4x/day. Still recovering.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 01/26/2021 and 3/1/2021. Presented to Med Cntr -ED on 1/21/2022 with complaints of shortness of breath. Transferred to another Med Cntr - to be hospitalized for COVID-19, acute hypoxemic respiratory failure, elevated troponin, and anemia. Treated with: dexamethasone, antibiotics, supplemental oxygen, and pressors. Respiratory status continued to worsen on BiPAP. Patient was DNAR and expired on 1/24/2022 at 0113.
Patient reports feeling slight tightness to chest to neck and to the left arm where she got the shot. Patient was assessed by EMS BP:149/79, pulse 81, Patient reports feeling better, symptoms improved. Cleared by EMS.
Pain in arm - swelling - redness traveled around and below shot to elbow. Pain lasted more than 24 hr. Dr. prescribed Clindamycin 300 mg 4 times a day 5 or 7 days redness & pain was gone - about 3 days after prescription.
Hearing loss in left ear around January 24. However, it was treated as infection with antibiotics (Amoxciiian-clav 875mg,Ofloxacin .3%). Hearing came back and the vaccine was taken (February 15) one week after completion of medications. 12 days after (first) vaccine (February 26), I suffered hearing loss again which is still the situation now. I am afraid to take the second vaccine.
On 2/22/00, the pt experienced "poxing" with three lesions on the face and one on the hand. No further information is available.
I went to work to numbness in my left arm, where I received the vaccine. The numbness did not go away, so my boss recommended I go to urgent care, due to the Johnson and Johnson vaccine being in the news for causing blood clots. I went to urgent care, the APNP took some blood samples to be safe. The D-Dimer came back abnormal, so she recommended I go to the emergency room immediately. I then went to the emergency room where they took multiple test. Luckily there was not a blood clot at that time, but it costed my more than $4,000 due to get the vaccine. I have not had abnormal blood samples before, plus was had a physical through my work and scored 99 out of 100 for my health.
This employee reports having "excruciating pain when moving her L. arm up and down in a lateral motion and reports having tingling in her ring finger. Denies swelling/redness reports that the pain is worse with certain movements. The pain started 1/19/2022. This employee states she is continuing physical movements to help with soreness.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented significant pain at injection site during at least 72 hours,
Swelling and knot on left arm with accompanying fatigue and malaise and discomfort at the site of injection; itching in same location days later.
Left thigh with 16 cm circular erythema, warm to touch and tender. BENADRYL 12.5 mg/ 5 ml - gave 5 ml PO in office and cool pack 15 minutes every 6 hrs. Cephalexin 250 mg/5 ml - 9 ml PO 7 d.
Patient was here to receive 2nd dose  of pfizer to complete primary series.  Patient received the bivalent pfizer dose instead.  Patient is not experiencing any adverse effects and was told to contact us if that changed.
her seasonal allergies were terrible like they were when she was a kid; after the second booster she got more spots; This spontaneous case was reported by a patient and describes the occurrence of MELANOCYTIC NAEVUS (after the second booster she got more spots) and SEASONAL ALLERGY (her seasonal allergies were terrible like they were when she was a kid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 058H21A, 017B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced MELANOCYTIC NAEVUS (after the second booster she got more spots). On an unknown date, the patient experienced SEASONAL ALLERGY (her seasonal allergies were terrible like they were when she was a kid). At the time of the report, MELANOCYTIC NAEVUS (after the second booster she got more spots) and SEASONAL ALLERGY (her seasonal allergies were terrible like they were when she was a kid) outcome was unknown.            No concomitant drug information was provided. Patient's year of birth was reported. It was reported that the patient felt that her immune system had messed -up as she experienced terrible allergies.  No treatment drug information was provided.   This case was linked to MOD-2022-629684 (Patient Link).
At first his arm was sore but then it progressed to increased arm pain, splotchy redness across chest, red face. Also Reports Chest Pain. Mom gave Benadryl last 2 days - advised by nurse advice line.  He had his HPV vaccine on Wednesday.  They report that into Thursday he developed arm redness and pain, chest redness, face redness, and they called the nurse line.  They have been using Benadryl and the redness has mainly resolved but he continues to have left arm pain, shoulder pain, back pain, and chest pain on the left.  He is not having shortness of breath, rash, difficulty swallowing, swelling, nausea, vomiting, or other symptoms.  His main symptom is just discomfort on the left side of his body where the vaccine was given.
Lack appetite, sores in mouth, lip blisters, chills, temp 99.3 C/0 increased back pain.
1 day after the 2nd shot I was out in the sun for about 25 minutes and got extremely sunburnt and had bad sun poisoning. I have never experience this before and the only change in my history was the vaccine. Today I was out in the sun again for 30 minutes with 30SPF on and my entire body got sunburnt today and sun poisoning again after only the 30 minutes in the sun. The only places that are red and itchy are places exposed to the sun.
Severe headaches, nausea and vomiting for longer than 2 weeks and unexpectedly became lactose intolerant.  Since my first dose in March, I have not been able to have any dairy when it has never been a problem before.
16 month old arrives to clinic with mother for vaccine update, however patient was administered 12 and older (gray cap) Pfizer ( COVID 19) by error. After realizing my administration error supervisor was notified immediately. Patient's PCP, medical director, director of immunization department and patient's mother where notified of error/incident. VEARS report  was created, mother wrote an incident report, mother of patient was advised by PCP if patient develops any adverse reactions to please head to the emergency room. In case patient has any questions or concerns mother was advised to contact the clinic. Supervisor will be following up with patient.
Blotchy rash; Rash looked like tiny bumps/rash on the underside of her breast; Headache; Did not get the second dose of the vaccine within the recommended period; Swelling at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number T2CS3, expiry date 1st December 2021) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on an unknown date, a year ago from the reporting date).   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and drug dose administration interval too long. On 23rd January 2020, the patient experienced headache. On 24th January 2020, the patient experienced blotchy rash and rash. On an unknown date, the outcome of the injection site swelling, rash and drug dose administration interval too long were unknown and the outcome of the blotchy rash was not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, blotchy rash, rash and headache to be related to Shingrix.  Additional details were received as follows: The patient did not get the second dose of the vaccine within the recommended period and that she was prescribed to restart the Shingrix vaccine series.   On 22nd January 2020, the caller received another dose of the Shingrix more than recommended interval, which led to lengthening of vaccination schedule. She stated that she experienced swelling at the injection site. The patient said that today at the day of reporting when she woke up, she noticed that she has a blotchy rash that spans from her neck and from her chin to her ear She also described having the rash on the underside of her breast.  She stated that the rash looked like tiny bumps, but did not appear to look likes hives and was not raised. She said that she had experienced rashes (not on her neck) before but it was usually associated with a fever and she did not have a fever this time. Caller also mentioned experiencing a headache after the vaccine was administered.  Caller was referred to reach out to her HCP for further guidance. The reporter consented to follow up.
Felt dizzy after the vaccination.   Some features of vertigo, but he was unable to further characterize.  No HA, CP, SOB, Nausea.  No numbness orally or peripherally. He was quite anxious about even coming for the vaccine. Initial BP was 129/78, P 88  O2 sat - 95%. No orthostasis. All VS remained stable. He felt better sitting up than lying down. Felt better after apple juice. He didn't know his symptoms of hypo or hyperglycemia. Ambulated comfortably before discharge to home.  Not classic Vaso-vagal reaction. Suspect anxiety.
On March 18, 2021 the patient started experiencing right-sided tongue numbness and loss of taste. It progressed to his face tingling and feeling sore. This went on for a week or so and progressed to absolute right-sided face numbness and face droop from forehead to neck.  Patient's mother is a registered nurse and conducted a full stroke assessment on him with no findings indicating stroke at all.  Patient saw his dentist between the time symptoms started and the full face droop happened thinking maybe he had something going on in his mouth and the dentist didn't find any issues, even with an x-ray. The patient went and saw a physician and was prescribed antibiotics in case he had an abscess that wasn't seen on the x-ray because everything was tingling, numb, or hurting in his mouth at this point. When the right-sided face droop happened, he went back to the physician and was diagnosed with Bell's palsy.
Today the site for the first time decided to swell; Today the site fir the first time decided to get red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Today the site for the first time decided to swell) and VACCINATION SITE ERYTHEMA (Today the site fir the first time decided to get red) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Today the site for the first time decided to swell) and VACCINATION SITE ERYTHEMA (Today the site fir the first time decided to get red). At the time of the report, VACCINATION SITE SWELLING (Today the site for the first time decided to swell) and VACCINATION SITE ERYTHEMA (Today the site fir the first time decided to get red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.
one week (7 days) after injection - left radial nerve palsy - hospitalized for three days still currently in therapy
inc temp unk how hi; also fussy-cries doesn't want to play when held;
rt arm swollen double-swollening to neck; t  unk but has one-crabby-hurts under both arms -rt leg burning-throat hurts rt p/having inject; c/o arm numb when got in the car and stinging;
I want to advise you that I had a very painful sensory and motor post (11 days post vaccine; lasting about 3 months) Pfizer #2 vaccine for Covid. I am a generally healthy 69 years old. The presenting symptoms (day 11) were a left foot drop, severe burning pain in all 4 extremities and a transient (about 3 weeks) unilateral supraclavicular (sensory) complete sensory loss.  My post vaccine neuropathy was a painful exacerbation of my underlying idiopathic slowly progressive idiopathic length dependent neuropathy. Now 6 months later, the underlying neuropathy has a new worse pain at baseline and decline in balance, motor control and sensation in my hands and feet.  I realize that there may be a much larger group of patients with peripheral neuropathy; many of these patients (like myself) have not had their reaction documented by the FDA or CDC.
pt exp a 1min episode of shaking @ daycare on 10/12/99;was not postictal;pt examined in office shortly after;MD did not feel this event represented a sz, however mom & grandma felt it was likely d/t vax;
caller mentioned she is allergic to Pneomovax; This report was received from Pfizer and was assigned manufacturer report number 2021070603 for PFIZER-BIONTECH COVID-19 VACCINE. This was originally reported by a female consumer of unknown age regarding herself.  There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (allergy to vaccine).  At the time of the report, the outcome of the event was unknown.  The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
hot at injection site; left arm swollen; itchy at injection site; felt feverish; injection site hot; Soreness in left arm; left arm swollen; red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot at injection site) and PERIPHERAL SWELLING (left arm swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot at injection site) and PERIPHERAL SWELLING (left arm swollen). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (hot at injection site) and PERIPHERAL SWELLING (left arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter.
A report was received from a health care professional on 9/29/03 concerning a 36 year old female vaccinee who experienced arm pain within 2 hours of receiving Fluvirin on 9/26/03. On 9/26/03, the vaccinee's entire arm, from the injection site to the fingertips hurt. The event resolved on 9/27/03. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300731 and PJP200300730. Follow up pending.
p/vax pt exp shoulder tightness; p/36hr pt devel nausea, fever & enlarged lymph nodes;pt outcome is unk;
Several hours after receiving the second vaccine, I started having a dull ache in my chest.  By morning, it went away.  7 days later it came back and was consistent.  I went to the ER after 5 days of consistently having a dull ache in my chest.  On March 12th, I had a CT scan of  my chest and the result was as follows: Pulmonary Embolism: a filling defect along a branch point of a right lower lobe segmental pulmonary artery with decreased opacification of the distal subsegmental pulmonary arteries at this location.
Woke at 6am  to feeling fatigue and nausea.  Shortly after fever started to climb, highest was 99.7.  I took Tylenol at 10am and it started to go back down.  Entire body hurts.  Head feels like a head cold but no runny nose.  Throat very dry, feel dehydrated but not.   Now it is 5pm temperature normal, extreme fatigue and entire body aches.
Pfizer 3/3/21, 3/24/21, 11/27/21. Positive on 1/17/22
doses were very painful; This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband via voicemail. The age at vaccination was not reported. It was reported that the Shngrix was very painful. The patient received Shingrix and experienced very painful. The patient's husband was told that it was normal, but was calling to find out why it was so painful. For the tolerance of 2nd dose, refere case US2019AMR122634.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On an unknown date, in or around December 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, 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 of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered disabling.