chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient mentioned that he and his wife took the initial Pfizer COVID vaccine and the bivalent COVID vaccine last Oct and had a sore arm. His wife started taking Miralax (propylene glycol) and possibly had a reaction to it. He wants to know if vaccines have the same product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA  Extreme stomach distress followed by massive red hives 1' wide surrounding entire torso and back.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 01-JAN-2012, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated in Emergency department for a painful rash that was diagnosed as severe case of shingles. As a direct and proximate result of these malfunctions, the patient 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. Additional information has been requested.
Immediately after receiving Rotateq Oral Vaccine patient suffered from severe colic for 30 minutes.
Low grade fever 99.5 for 2 days. "Covid arm"- swelling, hot to touch, redness, itching, sore to raise arm, chills
It started with congestive in my whole head.  I had a tick in my throat that turned into a sore throat.  I could not talk.   My hands and feet bones hurt really bad.  I develop SOB of breath with my asthma.  I went to the urgent care. They did not help me or do anything.  They did an EKG.  I went to the hospital.  They did blood work. They did a lung test and x-ray.  They did an EKG, normal result.  My blood work that I was getting a blood clot.  They did a CT scan, which did not show a blood clot.  They gave me prescript for it.  They also did a COVID-19 test, negative result.
Not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling good). At the time of the report, MALAISE (Not feeling good) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Concomitant product use was not provided.
pt recv vax 11APR95 & on 29MAY95 devel hives;hives have recurred twice since then;
Diagnosed with COVID-19 01/21/2022. First was severe chills, fever and I got up to go to the bathroom and I was shaking so bad, I couldn't get up. I lost my appetite and I lost about 10 lbs. I could feel that I had stuff in my lungs. My girlfriend said that I lost my color. About a two weeks later I went to the ER and they admitted to the hospital on 01/21/2022 and I got out 01/31/2022 with an oxygen and with a prescription of blood thinners.
Approx 24 h or more after shot had minor contusion from colliding with someone else at site of shot. After that blow to injection site, developed large, red erythematous reaction - 3" diam., itchy, painful, later in the day urticaria on back, chest and neck. Slowly resolving.
pt walked In to get Janssen vaccine. (8-23-21) about 1:30pm pt filled prevaccination checklist for covid-19 vaccine & screening/vaccination Adm. record No to (have you ever received a dose of Covid-19 vaccine). after Administering vaccine, try to report systems, Moderna 1st dose was reported on 8-21. (searched pharmacy & talked to pharmacist, and. confirmed Moderna was Administered on 8-21-21)
Vaccines given on 9/5/13 around 3:30 PM. Pt. awoke 8AM 9/6/13 not feeling well and started vomiting later. Injection sites clear of swelling, bruising, heat, and drainage.
my previous bout with Tinnitus has seed to become more amplified since vaccine shots as well as skin issue on a few fingers since vaccine shots.
First week tiredness,, lethargy and headache. Second week increased tiredness 1-3 hours after lunch . Day 15 called Doctor Pressure on left upper chest , increasing over 3 days.  12: am Sent to ER for work up - EKG,  blood test  for heart attack enzymes. chest x-ray. Repeat EKG and Blood work every 4 hours- with no change. 3:30 pm Admitted for further test next morning  9:am Nuclear non - stress test and 11:30 am Nuclear stress test results: All of  Heart getting blood flow with blockage.  discharged in afternoon
itchy rash on chest and back consistent with urticarial. Given steroids and Benadryl.
Several small lumps on my arm below where I got the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Several small lumps on my arm below where I got the vaccine) 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 MASS (Several small lumps on my arm below where I got the vaccine). At the time of the report, VACCINATION SITE MASS (Several small lumps on my arm below where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
shortness of breath; coughing problems; chest started tightening; hoarseness; chest hurts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (coughing problems), CHEST DISCOMFORT (chest started tightening), DYSPHONIA (hoarseness) and DYSPNOEA (shortness of breath) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COUGH (coughing problems) (seriousness criterion hospitalization), CHEST DISCOMFORT (chest started tightening) (seriousness criterion hospitalization) and DYSPHONIA (hoarseness) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization) and CHEST PAIN (chest hurts). At the time of the report, COUGH (coughing problems), CHEST DISCOMFORT (chest started tightening) and DYSPNOEA (shortness of breath) had not resolved and DYSPHONIA (hoarseness) and CHEST PAIN (chest hurts) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of these events included an epi-pen, Benadryl, Pepcid, water pill and an unspecified steroid.  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.; 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.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M028553, expiration date on 07-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the unspecifie temperature excursion. Data logger was involved in recording of the temperature excursions. There were unspecified previous excursions reported. Properly stored doses of sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot number and expiration date were not reported) were used to reconstitute the doses of the vaccine. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005237:
Mother reports doctor visit on 03/09/2006 due to redness of upper left arm.  Also several knots in this area.  Noticed this 03/08/2006 at 8PM.  Reports doctor said this was infection from the shot - not a reaction.  Gave him Omnicef.  Spoke with mother this AM, 03/13/2006, states child is fine, redness almost gone.
Redness; Itchiness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness) and SWELLING (Swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itchiness) and SWELLING (Swelling). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itchiness) and SWELLING (Swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional Information received and Reporter details were updated.
Information has been received from a pharmacist concerning a female (age not reported) nurse who was accidentally exposed to Pneumovax 23 about 0.25 ml orally. On 08-NOV-2006, while the nurse was administering Pneumovax 23 to a patient, she accidentally squirted the medication in her mouth (about 1/4 ml) and on her neck. The medication in her mouth (about 1/4 ml) and on her neck. The pharmacist reported that the nurse stated she had a bad taste in her mouth. The nurse brushed her teeth and used mouthwash. The nurse no longer has a bad taste in her mouth. The nurse had sought unspecified medical attention. There was no physician associated with this case as per the pharmacist. Subsequently, the patient recovered. Additional information has been requested.
On 4/20, patient consumed eggs and had rash breakout on trunk of body going down her arms and legs. Patient has eaten egg prior but not reacted.  Mother was treating it as a heat rash--keeping patient cool, dry, and applying lotion. On 4/22 during doctor visit for older sibling and doctor observed the patient's rash and confirmed it was an allergy. Doctor recommended use of Benadryl in case it did not go away on its own--did not need to use any. Rash disappeared 2 days after seeing the doctor. It turned into an eczema rash.  Rash has healed,now and patient is exclusively breastfeeding. However, rash flairs up if mother eats eggs.  Using Eucerin and Aquaphor as needed for breakouts.
Calls 12/4/15 at 10:40 AM. Says on evening of vaccination, experienced chills, feverish on through Saturday 11/28/15 where 5am says symptoms eased up. Calls today and says she has rash (light) on left neck and Rt neck has "swollen gland". Recommended to client that she see her primary doctor for eval.
Multiple unspecified patients were administered improperly stored doses of GARDASIL 9; exposed to 29.3 F for 16 hours; No adverse effect; This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient's were vaccinated with improperly stored doses of GARDASIL 9 lot # M016193 with expiry date of 24-APR-2018 (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 29.3 Fahrenheit for 16 hours and this was logged on a digital data logger. No adverse effects were reported. Product quality complaint was not involved. As of 21-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA000952: MERCK 1610USA003023:Mfr number.
Onset of Redness. Progressively started to swell, headache followed.  Redness is about entire size of bicep and warm to touch. Pt experiences slight pain at red site.
This spontaneous report was received from a pharmacist, regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-APR-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, intramuscularly, lot # L036245, expiration date on 09-FEB-2018 (anatomical location of administration was not mentioned)  for prophylaxis. Subsequently, on 31-OCT-2017 (about 6 months after her first dose) she was vaccinated with the second dose of GARDASIL 9. No adverse events were reported.
85 year old male who presents with 2 episodes loose black stools, weakness, decreased appetite, increased lethargy and subjective fever today, 02/22.  Again admitted and had further rheumatological and infectious work up with negative results  He was initially admitted to Hospital on 02/12 with fatigue, atypical chest pain, melena. He had received 2nd dose of Pfizer vaccine on 02/10. He was hospitalized from 02/12-02/15 and  thought to have viral pericarditis.  Diagnosis at discharge: SIRS DUE TO NONINFECTIOUS PROCESS W ACUTE ORGAN DYSFUNCTION.   He was started on celebrex in addition to the the colchicine as an anti-inflammatory.  After initiation of the anti inflammatory medications, patient's fever resolved, he started feeling better and his inflammatory markers decreased.  He was monitored for another days and was feeling better.  He is therefore being discharged home.  In view of the negative work up, there is suspicion that these may be a hyper inflammatory response to the COVID vaccine since his symptoms were temporally related.
I received my second COVID vaccine on 5/13/2021. My arm got intensely sore and it keeps getting bruised around the area randomly and it is still very sore weeks later. I can?t sleep on that side of my arm because it hurts and my arm is constantly ?falling asleep? . It hurts a lot and isn?t normal.
Information has been received regarding a case in litigation for Recombivax HB concerning a female who on 23-MAY-2000 was vaccinated with a dose of Recombivax HB.  Suspect vaccination included a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  Around 10-JUN-2003 the patient developed severe lower back pain and the following day experienced difficulty urinating.  On 20-Jun-2003, she was diagnosed with transverse myelitis, multiple sclerosis and neuropathy, but "different doctors suggested that the patient suffered from different diseases".  Upon internal review, transverse myelitis and multiple sclerosis were considered to be other important medical events.  No further information is available.
Dizziness and ringing of ears. For about 2 minutes. VS checked BP 118/74 heart 88 Temp 96.7 Patient recovered and able to responded alert and oriented. The father was present. Nurse watched for 15 minutes no further symptoms occurred.
apnea 12 hours after pediarix, prevnar, oral rotavirus.  apnea and cyanotic x 2 requiring emergency transport and near intubation, perhaps pending intubation 10/16/08-records received for DOS 10/14/08-presented to ED with apnea times 30 seconds with spontaneous breathing. DX Apnea. ALTE.  Transferred to another facility.  10/27/08-records received for DOS 10/14-10/16/08-DC DX: Pneumonia.  Fever.
has some soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got her shot yesterday (11Jan2021) and had some soreness in the arm but that was it. The outcome of the event was unknown.  Information on the lot/Batch number has been requested.
Information has been received from a consumer concerning his 11 year old grandson with no pertinent medical history who on approximately 06-OCT-2010 (reported as "about the sixth"), was vaccinated with GARDASIL (lot # not reported). Drug reactions/allergies was reported as "not sure possibly something". There was no concomitant medication. On approximately 06-OCT-2010 the patient "had dizziness, tiredness, upset stomach, loose bowels and developed acid reflux". Another reporter reported that the patient went to the doctor yesterday on 14-OCT-2010 and was prescribed an unspecified medication for acid reflux. The patient was seen by a nurse practitioner. The patient took a "blood test not sure". The patient's dizziness and tiredness and upset stomach and loose bowels and acid reflux persisted. Follow up information has been received from the nurse practitioner and medical records concerning the 11 year old male patient with no known drug allergy and the left fourth finger sprain and Gastrointestinal symptoms upset stomach 2 days before vaccination who on 28-SEP-210 was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly and a 0.5 ml dose of VARIVAX (Merck) (manufacturer unknown) subcutaneously. On 14-OCT-2010 the patient was seen in the office stating that since having GARDASIL vaccine 2 weeks ago, he experienced heartburn, diarrhea, gas, dizzy. The symptoms of Gastrointestinal symptoms upset stomach worsened 2 days after vaccination. The patient reported drinking more protein drinks and more chocolate milk in the last 2 weeks. Recently changed protein shake brands 2 weeks ago. The patient denied any previous issues with dairy. The patient had belching more frequently and nausea occurring in late afternoon. No vomiting. RLQ abdominal pain and in the LL! x 2 weeks. No radiation abdominal pain. Flatus more frequent and diarrhea. Patient reported "softer than normal but not liquid/watery." There was on change in color of stool or blood observed. The patient had body temperature 98.5 degrees Fahrenheit. Physical examination: The bowel sounds were hyperactive in all 4 quadrants and abdominal palpation revealed abnormalities. Direct tenderness mild, in the RLQ of the abdomen, negative McBurney's and in the LLQ of the abdomen but no acute tenderness in either RLQ/LLQ. Others were normal. The patient was assessed with heartburn and abdominal pain. The patient was given omeprazole 10 mg capsule delayed released, take one capsule daily might increase to twice daily if no relief in 2 weeks. Trial off protein shakes completely or switch back to previous brand as patient able to tolerate without difficulties. The patient was advised follow up for worsening or failure to improve. Additional information has been requested.
Moderna Covid vaccine booster of 0.5ml was given instead of the CDC recommended 0.25ml
pt recv vax 26FEB98 230PM &  235PM hive apparent @ site;hands swollen;240PM to MD instructed by MD to take DPH PRN;
She got her vaccine, started to have chills and a slight headache but not bad.  A few hours later throughout the evening had a low grade fever.  Around 8:00 AM had trouble breathing, wheezing, low grade fever and asthma.  When she gets sick with her asthma the first thing that happens that her lungs hurt, and hurts when she breaths and tightness.  This lasted for the entire day with shortness of breath.  She called her doctor and he said to use the inhaler every 3-4 hours, and she did some nebulizer treatments at home.  She took them every 4 hours the entire day and started to feel better around 4:00 PM.  Her lungs did not hurt anymore and had some relief, but still had some wheezing, and is much improved from yesterday.   She called her pulmonologist several times, and her PCP, Dr. trying to get a telehealth apt with her.  Her pulmonologist wanted her to go to the ER but with her symptoms and her autoimmune disease she decided to go to the UR but was a 3 hour wait and had to wait in her car so she went home and continued to take her breathing treatments.  The treatments started to improve her symptoms and by 10:00 PM she was feeling like herself again and was able to sleep last night.  She did have some trouble at 5:00 AM and had to give herself another breathing treatment.    Did call her doctor to see if she should take the steroids that she had, but continued with the breathing treatments and is improving.    She has some swollen lymph nodes underneath her left arm where she got the vaccine, which she feels is an autoimmune response, but it is something new and painful.  She does have an appointment to see her doctor on Monday to make sure that everything is OK.  She is a teacher and she has missed 2 days of work due to this response to the vaccine.
new onset HTN, generalized edema heavy menstrual cycle  continued sob and fatigued, activity intolerance enlarged heart as shown on imaging  studies completed on 2/21/22
This spontaneous report was received from a health care worker refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot number-K023159, expiry date-26-JUL-2016, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered to be not related to ROTATEQ. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
104 fever 7 days after shot. Fever lasted 4 days body broke out in rash all over for 7 days, loss of appetite and crankiness.
injection given 4/16 late morning and by the morning of 4/18, I had swelling of my ankles, wrists and hands. Both sides, stiff, loss of range of motion, pain and weakness.  Plus fatigue.  Now in my elbows and shoulders but not as bad. I have been to PT, my primary physician, a naturopathic clinic and have an appt with a rheumatologist.  The arthritic blood panel came back negative.  My thyroid panel shows high levels of antibodies.  I had COVID in march 2020.   it's a work in progress.