chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I still have a large amount of pain when I move that arm in a certain directions and I have been using mostly my right arm since the shot. It is difficult to put on a coat or a shirt. I have to bend totally over to take one off or put one on. Driving is ok. I cannot lift anything with that arm either. There has not been any swelling, bruising or redness in the area of the shot. It feels like it is the joint or the muscle itself. It even aches and has sharp pain occasionally when I am not using it. I have an appt. with a Dr. on another matter on Thursday and intend to ask him what is wrong. I have been applying warm packs and letting the shower run on it to no avail. I cannot take any aspirin, Tylenol or Advil for the pain.
Menstrual changes ? Had 2 periods in the cycle following second dose. Normal for 2 cycles, and then in the next cycle in August had 2 periods again in one cycle.
Received her 2nd dose of the Pfizer COVID19 vaccine, while sitting in vaccination seat she immediately felt faint. Syncopal event, diaphoretic, lost hearing. Pt laid on cot, knees up. BP 92/50 HR 47, unable to obtain Pulse Ox. RR 13.  EMS called, Paramedic evaluated the pt. BP came up to 104/72 HR 79 O2sat 99%. Pt reported feeling much better.  Pt has a history of passing out with vaccines however she did not pass out with the 1st dose. Mom signed refusal for transport with EMS. Mom states she will call the pts pediatrician. ED precautions given to pt and mom by paramedic.
This spontaneous case reported by a consumer, describes the occurrence of bone pain (bone/joint pain), vaccination site rash (rash at injection site) and arthralgia (bone/joint pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 00137959) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 6, 2021, patient experienced bone pain (bone/joint pain), vaccination site rash (rash at injection site) and arthralgia (bone/joint pain). At the time of the report, bone pain (bone/joint pain), vaccination site rash (rash at injection site) and arthralgia (bone/joint pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Injection site soreness and swelling, headache, muscle stiffness and ache, chills, skin sensitivity,  joint pain,  dizziness,  mild congestion, low energy
Sore arm; Hard to lift the arm; No energy; Barely can do any normal routine work / errands; Injection site is very sore; Very drained; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Hard to lift the arm), ASTHENIA (No energy), IMPAIRED WORK ABILITY (Barely can do any normal routine work / errands) and VACCINATION SITE PAIN (Injection site is very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Hard to lift the arm), ASTHENIA (No energy), IMPAIRED WORK ABILITY (Barely can do any normal routine work / errands), VACCINATION SITE PAIN (Injection site is very sore) and FATIGUE (Very drained). At the time of the report, PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Hard to lift the arm), ASTHENIA (No energy), IMPAIRED WORK ABILITY (Barely can do any normal routine work / errands), VACCINATION SITE PAIN (Injection site is very sore) and FATIGUE (Very drained) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
08/14/07 - Mother stated: Patient had reaction to MMR vaccine 10 days post vaccination.
11-26-21 Pt experienced hives occurred all over the body, one foot swelled up and pt had difficulty walking. 11-27-21 Pt went to his doctor and received diphenhydramine, IM steroids, and an oral steroid
Arm was sore; Red,  2x2 circle on my arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red,  2x2 circle on my arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red,  2x2 circle on my arm). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red,  2x2 circle on my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included warm soak  Company Comment: 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.; Reporter'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.
Weight loss, bladder cancer, high blood pressure and new dental issues. 1 month after receiving 2nd shot in October I started losing weight. This continued during the Thanksgiving and Christmas holidays and on into mid-January. I went from 165 (a benchmark weight for many years) to 155. At this point it was discovered I had bladder cancer. I have had excellent health for my first 83 years. My only surgical procedure was cataract removal in 2014. I have refrained from taking many of the vaccines down through the years. I took treatment in 1964. I had to take the flu vaccine in 2019 in order to keep driving. During my annual physical in June 2022 it was discovered my blood pressure was 160/80. I have never been above 130 for a high number during my years of measuring my blood pressure. I usually have a 128/80. Also, in the last 3 months I have had to have 1 tooth extracted, 2 root canals and 2 fillings. I  feel like my immune system has been impacted by this vaccine.
Uncontrollable muscle twitching in face, arms, legs, back, and eye.
first dose of vaccine on 2/11/2021, then hospitalized with covid pneumonia on 2/15/2021
Pt had syncopal episode 5-10 min after receiving 2 vaccines. Had CHI with brief LOC. Transported to ER "found to have 11 mm subdural" concussion. Required 15d hosp/rehab.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.  Company Comment: Based on the 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.
1st dose Oct2019, 2nd 14Nov2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In October 2019, received 1st dose). Concomitant products included INFLUENZA VACCINE.   On 14th November 2022, the patient received the 2nd dose of Shingrix. On 14th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment: The patient had received the second dose of the Shingrix on the day of reporting. The patient also got flu shot that day in the opposite arm.  No other information was reported to the agent by the patient. The reporter did not consent to follow-up. Additional supportive information: The patient did not receive 2 doses of Shingrix within the recommended interval which led to lengthening of vaccination schedule. The Flu shot was administered on the same day as Shingrix, however it was not captured as co-suspect and was captured as agency since the case was reported for medication error for Shingrix only. No follow up attempts possible as no contact information available. The case US2022168165 was identified as duplicate of US2022AMR169180. The case US2022AMR169180 would be voided, and all the future correspondence would be added in this case US2022168165 which stands as a case of record for this patient.
Breakthrough case of COVID, I had a sore throat, stuffy head, foggy head, I had some sweats. Still have some mucus in my chest so the Dr. prescribed promethazine cough syrup. I also took PAXLOVID for five days.
PMR (polymyalgia rheumatica); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004236.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 12Feb2021, for COVID-19 immunization.  The patient had an adverse reaction, an autoimmune condition was triggered, and the patient had to go on steroids for 10 months. She reportedly had high inflammation, a huge inflammatory response, lots of muscle and joint pain, and was diagnosed with PMR (polymyalgia rheumatica). The event was assessed as serious (medically significant). The outcome of the event was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event polymyalgia rheumatica and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Awakened around midnight.  Unable to sleep further. at about 4:00 AM got up for bathroom break and      My eyesight was unfocused (and remained so until the afternoon)      I had trouble moving my eyes; stiff; strange      My equilibrium was very poor and unsteady. Had to touch walls, etc      I was generally very weak and had trouble walking and sitting down, and then getting up At about 7-8AM, wrote my new PCP and as I was writing, I started to get intensley hot, sweat like I had malaria (I've never had), my heart was REALLY racing, and my skin under my t-shirt became so sensitive I felt like the t was pricking me. Very strange. Started to minimize reactions about 6-8 hours after waking up. I was unable to do my morning PT because of the weakness. I typically go to bed around 23:30, but on the 26th I went to bed at 21:00 and fell right to sleep. Next day (today) was back to 99.9999% normal. Did my morning PT (about 20 minutes plus 10 minutes on the bike). What I have is still soreness in knees. Luckily my pacemaker/defib didn't get set off by my heart incident. Feel free to call me, if you want.
Patient complained of metallic taste in mouth after vaccines.  Lasted approximately 4 hours.  Described as "sucking on coins".
This is a spontaneous report from a Pfizer sales representative who reported on behalf of a contactable nurse for three patients This report is the first of the three patients. An elderly female patient of an unspecified ethnicity received PREVNAR 13, on an unspecified date to an unspecified date at single dose. Two of the patients received vaccines were of Lot# J20343 and expiration date 31May2016 and the other dose was of Lot# L13519 and expiration date 01Jun2016. The patient medical history and concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown, injection site was hot to the touch and swollen on an unspecified date with outcome of unknown.
6 cm x 7 cm area of redness and swelling at injection site. Painful to touch. Began within 24 hours of injection. Saw provider 3 days after injection.
21 y/o reports swollen muscles of his right arm "twice as big as normal and rock hard" and of his upper body within 48 hours of receiving his 2nd anthrax injection. He states no chronic health problems, has no drug allergies and was not taking any other medications at the time he received he injection. He reports receiving a steroid injection in Fen 03 for a sever case of poison ivy. His symptoms are as follows: Anthrax # 1 tenderness and a nodule that resolved in 2 weeks. Anthrax # 2 he received the injection the morning of 22 Mar 03 SQ in the right deltoid, with some localized redness and tenderness. He engaged in PT that evening. Upon awakening 24 Mar he states "I couldn't move, all the muscles of my upper body- both arms, shoulders and upper back- were swollen". He self medicated with OTC Motrin and was seen by his PCP, where he was given a steroid injection, advised to discontinue Motrin and started on a Medrol Dose Pac (twenty one 4 mg tablets to be tapered daily until gone). He also reports that his urine specimen was brown in color and high in protein.   Assessment: Myalgias bilateral upper arms and back temporally associated with receipt of anthrax vaccine. Proteinuria. Advised temporary exemption from anthrax injection until all swelling is resolved and UA is free of protein. Recommend change in route of next injection(ie give injection IM in deltoid muscle). Recommend pre treatment with topical steroid before next injection
We are using Aventis flu vaccine, Fluzone, Lot #U1127AA administered by employee health nurse caused extreme burning and pain. Many patients swell with heat coming off it. Some patients had welts and streaking. Called company.
Client given second booster dose of Pfizer Covid 19 vaccine with no accompanying immunocompromising condition noted.
Patient developed a fever (high) and had to be hospitalized, apparently there was signs of sepsis and she was in the hospital for 5 days. Dr. is quoted as saying environmental exposure is the cause.
PATIENT LEFT VOICEMAIL ON 10/14/18 AT 2:19PM. PATIENT STATES: "I DON'T NEED A CALL BACK NECESSARILY, BUT I WANT TO TELL YOU AFTER GETTING FLU SHOT, BY THE NIGHTTIME I WAS NOT FEELING WELL AT ALL. MY LEFT ARM WAS SWOLLEN AND HURT, I GOT A BAD HEADACHE, I WAS ACHING ALL OVER MY BODY, AND MY TEETH HURT. I HAVEN'T STARTED FEELING BETTER UNTIL A LITTLE WHILE AGO (MEANING TODAY, 10/14). I NORMALLY NEVER HAD AN EFFECT FROM THE FLU SHOT BEFORE, AND I JUST WANTED YOU TO KNOW THAT."
Information has been received from a certified medical assistant concerning a 32 day old female patient with jaundice who on 31-OCT-2010 was vaccinated with a first dose of RECOMBIVAX HB (Lot# unknown). On 30-NOV-2010, the patient received IM the second 0.5 ml dose of RECOMBIVAX HB (Lot# 666187/1484Y) (Expiration date: 11-SEP-2012). There was no concomitant medication. The medical assistant reported that there were no side effects reported after the first dose. Next day after the second dose, on 01-DEC-2010, mother of child called the office stating child had fever. The same day child was taken to the emergency room and was admitted with fever of 101 F. It was unknown what type of treatment was given. Child was discharged from hospital on 03-DEC-2010, and had recovered. The reporter considered the event to be an other important medical event because the child went to the ER and was admitted. Additional information has been requested.
9 year old child received age-inappropriate Tdap licensed for age 11-64. No history previous vaccines. Vaccines were tolerated well per child's mother.
HISTORY OF PRESENT ILLNESS:  SHORTNESS OF BREATH (CHEST PAIN, sob , BACK PAIN STARTING TODAY AT 0900, STATES ADVIL AT 1000, SSENCOND COVID VACCINE YESTERDAY AT 1500) 32-year-old female with past medical history of anxiety, asthma, Hashimoto's thyroiditis, psoriasis who presents the emergency department with chief complaint of body aches and shortness of breath.  Patient is a nurse.  She received her 2nd dose of the Moderna vaccine for COVID-19 the day prior to arriving in the emergency department.  This morning she did feel some mild body aches but otherwise was feeling fine.  Starting later today after her shift at work she developed severe body aches bilateral upper shoulders and down her spine, she also reports some shortness of breath, dizziness.  She felt unsafe to drive home feeling like this.  She had taken some Advil earlier in the day around 10:00.  She denies any fever, nausea or vomiting.  No history of severe vaccine reaction or anaphylaxis.  She has had anaphylactic reaction to Enbrel prior.  She denies any throat swelling, muffled voice, difficulty swallowing, abdominal pain.    patient is mildly tachycardic and hypertensive.  Likely due to pain.  Patient is experiencing adverse reaction to the 2nd dose of the Moderna COVID-19 vaccine.  I discussed with her she is having an immune response to the vaccine.  She does have a history of rheumatoid arthritis which could contribute to the elevated immune response as well.  The patient is given 30 mg of IM Toradol for body aches here in the emergency department.  She is instructed to call PCP for close follow-up, rest, drink plenty of fluids.  She has no signs or symptoms consistent with anaphylaxis at this point.
This spontaneous report as received from a physician refers to a female patient "25 or 28 years" with no pertinent medical history. The patient was vaccinated with M-M-R II (dose, route and lot # not reported) on 31-MAY-2012 and developed adverse event 6 to 10 days later. The patient broke out in head to toe measles rash, and developed joint and muscle aches. These symptoms wax and wane. The patient has had 3 more lighter episodes within the past six weeks. Right now the patient got has rash on her face. In addition, the patient had some tachycardia symptoms and was placed on a beta blocker as treatment given for AE. No other co-suspects were reported. No concomitant medications were reported. The outcome was reported as not recovered/not resolved. Physician thought the Tachycardia symptoms is not related to M-M-R II. The patient had full chemistry panel including CBC and Sed Rate all normal, in addition HIV test negative, Rheumatoid Arthritis test negative, Vitamin A test pending and sought medical attention via physician followup. Additional information has been requested.
Patient experienced flu-like symptoms then felt better. A day or two later patients arm became red. The redness spread from shoulder to elbow and was a little warm to the touch.
Swelling, pain in left armpit and nodes, ice for treatment..pain came on 5 days after shot
felt tingling in my hands; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt tingling in my hands) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ALPRAZOLAM (XANAX) and TRAMADOL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PARAESTHESIA (felt tingling in my hands). At the time of the report, PARAESTHESIA (felt tingling in my hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the 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.
Within 30-45 minutes after receiving the first of a 3 shot series of Hepatitis B vaccine, pt developed hives on his face, was very itchy and also had tightness in his throat. Benadryl 50 mg PO given, and sent to a medical facility for follow up.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 25-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Pt recvd 2 doses of Engerix-B & exp no reaction following 1st dose but 2nd day p/dose 2 pt fainted & then had total paralysis for over 3 hrs; also exp memory loss, was extremely tired, had fever & tried to do bodily harm; 30JUN92 seen in ER
Information has been received from a physician concerning a female (demographics not provided) who on 29-MAR-2007 was vaccinated intramuscularly with Pneumovax 23 (Lot#655290/0959F).  On 31-MAR-2007 the patient experienced an injection site reaction (NOS).  The patient sought unspecified medical advice.  At the time of this report the patient was recovering from the events.  Additional information has been requested.
fever; hand-foot-mouth desease; rash; wrong  vaccine administered; This case was reported by a physician and described the occurrence of fever in a 2-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 24th May 2019, the patient received Havrix adult. On 24th May 2019, unknown after receiving Havrix adult, the patient experienced accidental overdose. On 27th May 2019, 3 days after receiving Havrix adult, the patient experienced fever, hand, foot and mouth disease and rash. On an unknown date, the outcome of the fever, hand, foot and mouth disease, rash and accidental overdose were unknown.   It was unknown if the reporter considered the fever, hand, foot and mouth disease and rash to be related to Havrix adult.  Additional details were provided as follows: The patient had inadvertently received adult dose of Havrix instead of pediatric dose of Havrix, which led to accidental underdose. The patient developed fever and a rash that looked like classic hand foot mouth disease. One of the patient experienced similar adverse event but more mild symptoms.  This case was linked to case US2019AMR104031 (twin's case ), reported by the same reporter