chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site pain; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (fever) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A) and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection, Allergy and Appetite disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (fever) and HEADACHE (Headache) had resolved.            Concomitant medication included medications for  blood pressure, HIV medicine, allergy pills, appetite pills, stomach pills. Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-054219 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event resolved and Patient declined FU; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054219:First dose
experiencing redness at the injection site (left arm)./redness started to spread to the top of her arm over; experiencing itchiness at the injection site (left arm).; pain at the injection site (left arm).; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2022, the patient received the 1st dose of Shingrix (intramuscular). On 11th February 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix and less than a day patient experienced redness, itchiness, and pain at the injection site into left deltoid (left arm). The patient reported that redness started to spread to the top of her arm over the next eight days and eventually retreated.  The patient reporter that all symptoms had resolved. The reporter consented to follow up.
Myalgia, Fever,  freezing head to toe, uncontrollable shaking, 101 degree F temp, sour stomach, body aches, fatigue Narrative:  Patient took OTC advil and omeprazole to treat reaction
Patient received vaccines, as noted below, on 10/16/07. Mother called office nurse and reported that patient's (R) arm was red and swollen (10-17-07). Mother called office nurse on 10/22/07 and reported patient's arm, (R), swelled to approx. softball size around site of injection. Additionally, blisters formed around injection site, since initial phone call on 10-17-07. Today, 10-22-07, swelling gone, blisters gone, and there is slight bruising only.
Information has been received from the patient's parent via the Merck Corporate Twitter page on 02-FEB-2015 referring to the 21 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (strength, lot number, expiry date, route and dose were not reported). On an unknown date when she was 21 year old, the patient was disabled by GARDASIL, also reported as "she's one-less". The outcome was not reported. Additional information has been requested.
Pneumonia; Shortness of breath (SOB); Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). an unknown date, the patient experienced DYSPNOEA (Shortness of breath (SOB)) and BACK PAIN (Back pain). At the time of the report, PNEUMONIA (Pneumonia), DYSPNOEA (Shortness of breath (SOB)) and BACK PAIN (Back pain) outcome was unknown.            Concomitant product use was not provided. 2 weeks after receiving 2nd injection, the patient developed shortness of breath (SOB), back pain, and was diagnosed with pneumonia, never had it before.  Treatment information was unknown.  Company comment:Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Mother states child had mild cold with no fever at time of vaccination. Mother states child started with a fever of 102F on 1/27/04 at 12am. Saw pediatrician on 1/30/04. Pediatrician diagnosed child with upper respiratory infection. Child given 5 day perscription of Zithromax. Mother states did not mention to MD that child had immunizations on 1/26/04.  Fever gone as of 2/2/04, but rash on back and abdomen started that day. On 2/3/04, rash gone and child recovered. Rash did not require MD visit.  Note: This was child's first immunization using Pediarix, but child did have 2 previous doses of DTaP, 2 previous doses of IPV, and 2 previous doses of Hepatitis B. Child also has had 1 previous dose of Hib, but was given as Comvax previously. Child has had no prior reactions to any vaccinations.
Severe fatigue, muscle and joint pain, headache, low grade temp, could not get out of bed or work. Sx not resolved with 48 to 72 hours. Sought medical treatment.
Passed out after standing up 10 mins after receiving HPV#2. Hit head on floor. Was despondent for 30 secs to 1 min. When awake & alert attempted to get up on own and became weak again, almost passing out again. C/O head hurting, ice applied.
the pain went into his right shoulder& now is in his legs & toe; the shot area was painful; the pain went into his right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the pain went into his right shoulder& now is in his legs & toe), VACCINATION SITE PAIN (the shot area was painful) and ARTHRALGIA (the pain went into his right shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 024C21A and 016C21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Svere arthritis in spine & all joints.).   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain went into his right shoulder& now is in his legs & toe), VACCINATION SITE PAIN (the shot area was painful) and ARTHRALGIA (the pain went into his right shoulder). At the time of the report, PAIN IN EXTREMITY (the pain went into his right shoulder& now is in his legs & toe), VACCINATION SITE PAIN (the shot area was painful) and ARTHRALGIA (the pain went into his right shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No Concomitant medication was reported. After his booster dose the patient  shot area was painful.  As that declined the pain went into his right shoulder & now is in his legs & toe.  He also mentioned being stuffed up sometimes due to his lifestyle.
Patient was given vaccine that was expired one week. Unknown at time of vaccination. No adverse reaction at time of vaccination.
Swollen lymph nodes on left side for a few days, then 1 week after getting vaccinated, broke out in hives on left side only.  Did not take medication for hives, they subsided within a couple hours.  The left side is the vaccinated side.
Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 8/25/2022 Discharge Date: 8/28/2022  PRESENTING PROBLEM: Atrial fibrillation with RVR (HCC) [I48.91] Acute respiratory failure with hypoxia (HCC) [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: The patient is an 87 y.o. male with h/o paroxysmal A-Fib/Flutter (on chronic Eliquis), essential HTN, NHL and recent diagnosis of COVID-19 infection via home test, who presented on 8/25 with c/o 2-day h/o sore throat, myalgias, and fatigue.  More recently, he has developed an accompanying cough and sinus/nasal congestion.  Cough has been increasingly productive.  He has measured intermittent fevers at home.  Family sought advice from his PCP, who referred them to the ER for additional evaluation.   In the ER, he was afebrile, borderline hypotensive, tachycardic, and tachypneic, hypoxic to 89% on baseline room air and maintained a SpO2 in the low to mid 90's on 2-3L via NC.  His initial labs were mostly unrevealing, with unremarkable CMP and CBC, and with only mild lactate elevation to 2.2.  CXR was limited but showed no clear intrathoracic processes.   EKG initially showed a wide complex tachycardia but he converted spontaneously into a sinus pattern with premature SV complexes. He remained comfortable and chest pain-free.  He was maintaining stable BP and HR's consistently in the 80-90's at rest and with ambulation to use the restroom.       While in the ER, he was given 1L of IV NS, a dose of IV labetalol, and started on dexamethasone. He was admitted with acute respiratory failure with hypoxia related to covid-19 for supportive care and monitoring.   The patient was weaned to room air on arrival to the inpatient floor on 8/26. He was placed on oxygen during the night into 8/27. He was observed for one more night and an overnight sleep study was completed as well as a walking sat study; he did not need supplemental oxygen. His Covid symptoms were minimal, an occasional cough, and fatigue. His appetite improved and intake was adequate.    He had three episodes of short duration wide complex tachycardia observed on telemetry while inpatient, he was asymptomatic. His metoprolol was increased from 25 to 50 mg, and no further tachycardia was noted. He will be discharged with a 14-day CV patch and recommended follow up with cardiology.   He was discharged home in stable condition, prescriptions sent to his pharmacy for tessalon and metoprolol XL 50 mg. Follow up appointment to be made by patient with PCP and Dr. from cardiology.
Date of Awareness:  8/13/21  73 y/o male who takes Pomalyst, dexamethasone and daratumumab for MM.  Pt was fully vaccinated against Covid-19 but presented to ER on 7/14/21-7/22/21 with SOB and was subsequently admitted for treatment of Covid-19.  Upon admission he was started on dexamethasone and Remdesivir.  He also received a dose of convalescent plasma.  His IGG level was found to be low, and after consultation with immunology he received two doses of IVIG and also treated with azithromycin and ceftriaxone for possible superimposed CAP.  Patient was eventually d/c'd home in stable condition but next cycle of chemo was delayed several weeks to allow patient to recover.  Patient will resume next cycle on 8/16/21
pt recv vax 4APR97 & on 18APR97 started devel bumps all over head to toe;seen in ER 22APR97 because rash/hives kept spreading;MD dx allergic rxn to MMR;given med;allerg response resolved 28APR97;
Resident went out of facility to the Fairgrounds  on 2/25/21 for an appointment at 11:30 to receive second dose of Moderna vaccine. Someone from the local Fire Department came to the facility and administered another dose to the patient on 2/25/21 at 3:30pm but actually administered to the wrong patient. on 2/25/21 at 6:20pm, the patient experienced respiratory distress. Pulse oximetry was 85%. BP 175/86. Pulse was 102. Temperature was 102.2. Nurse  manager at the facility was notified and when she and the nurse spoke to each other, the patient stated he had two vaccines today. This was when the double dose was discovered.  The patient was sent out to the hospital emergency department and was admitted. The patient was on a bipap overnight. Condition has improved this morning.
Redness & warm to touch below site. Itchy at and bellow site. Tingling / pins & needles and pain left arm and armpit. Shoulder, arm feel tight/ swollen. Bump / induration apx 5+ cm across.
Patient received Kinrix instead of Infanrix. No harm to patient. No adverse outcomes.
Muscle under arm sore & feels swollen, neck shoulder & behind ear hurts, swollen & painful when sleeping or moving on left side.
On 01/21/2022 at 15:46 nurse administered second dose of the Pfizer pediatric vaccine to 8 year old patient. Pfizer pediatric dose of 0.2 ml was administered prior to reconstitution of the vaccine vail.
Severe electric shock to left side of temple.  Initial diagnosis is left trigeminal neuralgia.  Diagnosed on 6-21-21
administered a dose of GARDASIL 9 during her pregnancy; This spontaneous prospective pregnancy report was received from a 36-year-old female patient reporting on herself. The patient did not have any concomitant medications and pertinent medical history. The patient's concurrent conditions were not reported. The patient was allergic to penicillin, bupropion hydrochloride (WELLBUTRIN), dust and tree nuts. On 16-DEC-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, anatomical location, lot number and expiration date were not reported) during her pregnancy as routine vaccination (exposure during pregnancy). The patient was not aware that she was pregnant when she received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 23-DEC-2019, the patient had office visit  to discuss birth control options. During that visit, standard pregnancy testing (urine pregnancy test) was performed, and the patient was found to be 7 weeks and 5 days pregnant with Last Menstrual Period (LMP) of 30-OCT-2019 and Estimated Date of Delivery (EDD) of 05-AUG-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 6 weeks of pregnancy. The pregnancy outcome was outcome pending. The fetal outcome was unknown. The patient reported that she was not experiencing any symptoms so far and had not sought medical attention for her pregnancy yet. No product quality complaints were involved.
After receiving the vaccine, I have become intolerant to many foods. I was already lactose intolerant, but am now intolerant to gluten, corn, soy, egg, seasame seed, cocoa, tomato, and am still figuring out the rest.   My digestive and other issues began after getting the first vaccine shot.
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. On 17-JUL-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at physician office as recommended by her physicians for the long-term prevention of shingles. The vaccine did not prevent shingles as intended; instead the patient contracted a persistent strain of shingles  or herpes zoster. On or about 16-APR-2016, the patient was treated for and was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Pt went to ER on 1/4/00, with 5 days of abd pain, 3 days of vomiting & diarrhea, was jaundiced. Hepatomegaly, 1/5/00. Pruritus, 1/11/00. Resolution of sx's by end of mo. No one else in family w/hepatitis.
Pt w/ hx of sulfa allergy (trouble breathing/anaphylaxis) and acetazolamide allergy. PMH significant for Osteopenia, HLD, Lumbar spondylosis, and thrombosed external hemorrhoids. Known medications include fosamax and statin 25mins post vaccination, pt reported mild chest tightness. MAR announced approximately 9:14 am.   Airway: patent Breathing: WNL, RR 24/min, 02 sats 97 to 99%RA.    MD auscultated lung fields   Circulation: normal skin color, warm and dry, pulses palpable with regular rate and rhythm   Pt cc started discomfort, left side neck pressure, chest tightness, light headed, 12 LEAD EKG completed, NSR HR 60s.  Pt denies resp distress.   Pt AX0 x4, responds to verbal commands   Vitals:  9:20 am R side arm, lying down BP 139/74, HR 77 9:22 am R side arm, lying down BP 146/75, HR 68 9:35 am R side arm, lying down BP 140/68, HR 62, RR 24/min   MD counseled pt, ER precautions given, follow up w/PCP, and to inquire in future, if more boosters/vaccine future for COVID-19, discuss w/ PCP if alternative then   Pt assisted ambulation, pt no distress.  Pt refused to go ER/further evaluation.    Pt assisted to car, will drive self home.
Starting 06/14/2022, I took her to the ER due to her coughing and having 4 rectal hemorrhages. They diagnosed her with an upper respiratory infection due to a positive COVID test. She was hospitalized for four days (until 06/17/2022). The doctor said he was very happy that she had all the vaccines and boosters for COVID because she reacted very mildly to the infection. He was surprised of how mild her COVID infection was given her age. She did not have trouble breathing. She was treated with antibiotics and responded well. Also, she had some blood transfusions due to the hemorrhoids. She's slowly recovering back to her normal self. 2 weeks after being released, I took her to see her primary care doctor. Bloodwork showed she had become anemic but likely due to the hemorrhoids. She has started an iron rich diet and will follow up next month for another blood test. She is still fatigued and has a slight loss of appetite. Gets slightly out of breath upon exertion.
She got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported ILLNESS (non-serious), outcome unknown.  The seriousness of the event was reported as non-serious. The reporter reported that she got sick but it had nothing to do with the COVID shot.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  Patient received the Jansen COVID 19 vaccine in May 2021. The patient tested positive for COVID 19 on 12 August 2021 and was hospitalized with hypoxia and COVID pneumonia. The patient was treated and discharged on oxygen on 23 Aug 21. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
pt devel fever & abdo cramps p/each dose of vax w/sx inc w/each dose; last dose high fever-nausea accompanied all doses;
Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Patient received vaccine at 0935 and reported approximately 10 minutes after vaccine experienced itching to arms and face, progressing to the Bilateral arms and back.  Alerted observation staff @ 25 minutes and patient was taken to the first aid station.   Patient denies any SOB, Swelling, no CP and Patient is A & O x 3, VSS at B/P 1238/76, HR 76, RR 18, SaO2 at 95% on RA.   1025-Itching had improved.  1030-B/P 126/68, HR 80, RR 16, SaO2:96% on RA.   1045-Itching improved but residual itching continues-repeated Benadryl 25mg Oral liquid.  11:00-Observed patient for 45 minutes and discharged patient after itching had improved with instructions for the patient to follow up with PCP.  Patient communicated understanding and had no further question prior to discharge home today.   1019- Patient given Benadryl 25 mg Oral liquid.
t105 R w/sz approx 5 hrs p/vax; unresponsive p/sz; ER MD dx ear infect; THis not visualized in clinic;