chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a physician in the USA on 05-October-2005.  A cluster of 6 patients was administered Daptacel in error instead of Adacel vaccine. Case 2: A female patient, (the wife of the reporting physician, age not reported) who received the Daptacel vaccine in error, complained of soreness at the injection site. It was unknown if she recovered. Further information is expected. The details of the reporting physician (the husband) who received the Daptacel vaccine in error is provided in case 2005-02037. Follow-up information received on 27/Dec/2005 from a health care professional. The patient received the Daptacel vaccine in the left upper arm intra-muscularly on 21/Sep/2005 at 15:00. At 15:05 she experienced a sore arm that lasted seven days. Per the reporter, the adverse event had resolved at the time of this report. No further information is expected.
Pt recvd vax & that evening exp shakes, fever, anxiety & chills; sx resolved w/in 24 hrs;
Patient fainted. At first felt like she was going to vomit then fainted. Gave Pt water and assisted to chair.
PATIENT STATED THAT SHE IMMEDIATELY HAD SWELLING AT THE INJECTION SITE ON THE LEFT ARM.  THEN 3/23  IN THE MORNING SHE DEVELOPED A RASH ALL OVER THAT "LOOKS LIKE A SUNBURN."  SHE CONTACTED HER DR THAT TOLD HER TO PLACE ON THE SWALLON AREA OF THE ARM. AND HE ADVISED HER TO CONTACT THE PHARMACY
This spontaneous report was received from a registered nurse. Referring that, on an unknown date, one vial of M-M-R II (which had the lot number of L028273, expiration date 28-JUL-2017) was improperly stored in the same place in which was usually stored the sterile water diluent vials (supplied with M-M-R II) at 72F for 18 hours. However, this vial of M-M-R II was not administered to anyone. The reporter also stated that the M-M-R II vial label looks too similar to the sterile water diluent vial. There was not product quality complaint involved. Additional information is not expected, because the reporter declined to provide further information.
About 3 hours after I came home. I was extremely fatigue. I felt as if I just wanted lay down and whine. It stayed this way until about 6pm that night. I was nausea, dizzy and a headache beyond any migraine I've ever had. As I laid there, I felt as if I was having an out of body experience. My fever was 101, which is really high for me. I stayed put all night and was watched by my family. About 2am, I could not move and could not really talk or move. I had to be lifted off the couch and was walked to the bathroom. I had a rash from head to toe. My skin was red like sunburn. The bumps were raised and looked liked little dots. It covered my entire body for 2 days. I had a fever that would not break. I had to consult with doctors, the said to continue with Tylenol and ibuprofen, and the recommended drinking orange juice to help some with the body pain. It was awful I was that entire way for at least a week. Each day the pain was getting better. The next week it was just a headache and rash without the bumps, just red skin. It started to fully all go away after 3 weeks. I want to cry because this was such a terrible experience, I had this happen on the all the doses but this dose 3 was the worst. I have a fear of having to take another vaccine.
Information has been received from a physician concerning a 21 year old female with rhabdomyosarcoma who was on an unspecified date was vaccinated with a second dose of GARDASIL.  Subsequently a couple of days after vaccination with GARDASIL the patient developed mild bruising on both her thighs.  Medical attention was sought at the office.  At the time of the report the patient was recovering.  Additional information has been requested.
patient was administered 5th DTaP to early, 2 years of age, no report of side effects by parent
First shot given 2/7/2021; no side effects out side of a sore arm. Second shot given 3/7/2021; within 24hrs developed advanced memory loss, cognition, conceptualization, relativistic reasoning, spatial disorientation, and recognition issues with family member/s primarily in the evening. The symptoms of NPH, but amplified, now with Alzheimer (DAT) like symptoms accompanying it previously not significantly present. She's lived in this house with us for 33 years (doesn't know where we are and it is no longer familiar to her) and has been married to my father who she failed to recognize in the evening  on multiple occasions since.
Pt devel fever noc of 16OCT91; pt taken to ER t104.4 R, no other sx; CXR showed LL lobe infiltrate; dx poss pneumonia; pt given meds;
Had the 2 shots and have shingles/Suspected vaccination failure; Shingles on the back of neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the 2 shots and have shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on the back of neck). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received two doses of Shingles vaccine in 2020. The patient now has experienced the shingles on the back of his/her neck and it was not picnic. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis, only 3 months after she received PREVNAR 13 (dose, frequency and route of administration were unspecified) also for prophylaxis. On an unknown date, the patient developed a big bump at her injection site for PNEUMOVAX 23, so much so that she could not move her arm "anymore". However, it was also reported that the injection site mass lasted about a week. The relatedness assessment between PNEUMOVAX 23 and injection site mass was not provided. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA009926: US-009507513-1705USA014940.
Client states had headache 7 PM 10/28/03. Took Tylenol and 1/2 Ambien and went to sleep. 10/29/03 7 PM, noticed hives on upper right arm and axilla. Complained of tender, swollen lymph glands in right axilla. Used hydrocortisone cream. 10/30/03 12:55 PM into health department to show RN the hives on right upper arm. Complains that it is swollen (arm upper) and complains that she things she is somewhat short of breath; no cyanosis noted. Encouraged her to seek medical attention in light of her increasing apprehension. Client states she felt ok to drive to physician's office. 11/17/03 Client came into health department to complete report. States that she went to the doctor's office on 10/30/03. She states that she became ill and started heaving, vomiting and hyperventilating while waiting in the lobby to be seen by the doctor. She states that they gave her solumedrol and then transported her to the hospital by emergency squad. She was kept in the hospital for one day. States no ill effects following release from hospital. The medical record received on 12/31/03 states anxiety, weakness, achy, itching, tightness in chest and nausea.
This spontaneous report as received from a physician refers to a 17 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. It was reported that the patient received his first dose of VARIVAX (Merck) "as a child". Route of administration and lot number of this vaccination was not reported. There was no concomitant medication. It was reported that the patient had titers drawn on an unspecified date which showed that the patient was low for immunity. The patient was given a second dose of VARIVAX (Merck) intramuscularly on 03-SEP-2013. Lot number was reported as J003705 with an expiration date of 27-MAR-2015. The patient was then administered a PPD test "2 or 3 days prior to 13-SEP-2013. On 13-SEP-2013, the PPD skin test result was "strongly positive". It was reported that no treatment was given for the adverse event. No further information was provided. Additional information has been requested.
Pt developed dizziness and nausea shortly, within 5-10 minutes, post vax. Improved by resting supine and observation for about 15 minutes and then discharged. Within 2 hours, mom called reporting emesis and dizziness. Pt directed to ER where objective finding was tachycardia and mildly elevated blood pressure. Pt was hydrated and discharged within 4 hours.
Information has been received from a healthcare professional concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently, the pt experienced a prolonged seizure. The prolonged seizure was considered a significant medical event. The pt's cousin also experienced a seizure following vaccination with varicella virus vaccine live. No further information is available.
Well circumscribed areas of urticaria on bilateral arms and legs-specifically large areas on back of bilateral thighs, elbows, knees, lower legs above ankles.
PT CAME IN FOR SECOND SHOT. she IS KNOWN TO HAVE FAINTING/DIZZY SPELLS POST VACCINE. wAS LAID SUPINE FOR SECOND VACCINE AND BEGAN HAVING SHIVERS AND DIZZINESS WITH IN 5 MINS. HUSBAND WITH HER, SAYS THIS IS NORMAL. PT REPORTS FEELING MUCH BETTER AND ASKED TO LEAVE. 12:03: BP-136/88 p 64 rESP 18 100%; 12:09-BP 116/65, p 60, rESP 16 100%
When I got the injection, the shot was very easy. I sat in the chair and started to get very warm. The warmth went from my left arm to across my chest. It was hot on my chest, and it went to my heart. My chest started pounding, and I couldn't breathe. The pharmacy called the EMT's, and they gave me two injections of Benadryl. The Benadryl help with my breathing and I was immediately taken to an ER.  They monitored me on an EKG. My heart rate was rapid, and my blood pressure was high. They prescribed me Prednisone for 4 days.  I was released from the ER and have been taking the prescribed medicine. I have been having blood pressure spikes for no reason. It makes me want to pass out. I feel short of breath and feelings of something pushing something inside of me. I think the blood pressure is a symptom of something else going on. I have ended up in the ER 4 times after this event. I am now taking Carvedilol 12.5mg and Lisinopril 2.5mg since the vaccine.
Throat tight, sinus swollen, eyes swollen and matted . General feeling of ache.  I took Benadryl and Tylenol to relieve some symptoms. This morning I still don?t feel very good. I am better than last night.
Felt bad night of 5/24. Increased redness from 5/25-5/26, tender to touch. No fever.
Did not receive 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027-A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd vaccine) had resolved. Not Provided      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.   no concomitant medications are provided.
Vaccine administered on 12/6/2019. On 12/8/2019, patient reports she developed a red raised rash on left arm to left wrist that spread to back and bottom. Rash was pruritic
My head is hurting so bad; My body is aching; My jaw hurts; I am having difficulty breathing; yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever), HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever). On 16-Jun-2021, the patient experienced HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing). The patient was treated with ALBUTEROL SULFATE (tracheal) for Breathing difficult, at a dose of 1 dosage form; VITAMIN D3 (oral) for Pyrexia, at a dose of 1 dosage form; SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]) (oral) for Pyrexia, at a dose of 1 dosage form and ZINC for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever), HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature (97.7-99.5): 99.9 degree fahrenheit (High) yesterday my temperature was 99.9. On 16-Jun-2021, Body temperature (97.7-99.5): 101.9 degree fahrenheit (High) today it is 101.9.     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.   No concomitant medication provided.  Treatment medication included albuterol inhaler, vitamin D3, elderberry syrup, zinc.
Site of inject swollen and hot.  Fever muscle weakness, sore joints, headache, tightness in chest.
This spontaneous report was received from a 55-year-old female patient, who was reporting on herself. The patient's pertinent medical history included chickenpox. Her concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection, in an unspecified arm (dose, route of administration, lot # and expiry date were not reported) for prevention of Shingles. On an unknown date (reported as "a few days after she took her vaccine"), the patient experienced Shingles. Her arm broke into a painful rash and the patient was in so much pain that she "wanted to cut her arm off". Additionally, the patient experienced a hard knot on her arm and she was no longer able to use her arm (onset dates were not reported). The patient went to the doctor, but claimed that no doctor would touch it. She did not receive any treatment for the events and stated she could not receive another shot it that unspecified arm ever again. The outcome of the events was reported as not recovered. The patient considered Shingles to be related to ZOSTAVAX. The causality of a hard knot on her arm and not being able to use her arm was not reported. Additional information is not expected as there was no consent to contact the physician.
Patient states he developed a cough on 1/1/14 that progressively worsened into severe chest congestion. On 1/7/14 he received azithromycin and felt better on 1/9. Still coughing on 1/16 and plans to go back to his MD for recheck. Also small bruise at injection site.
Patient presented with vitals 160/79. Patient approached by clinical observer as a check-in and patient mentioned feeling dizzy. Patient walked to tent and stated dizziness did not worsen. After resting in chair for a few minutes, pt states he is feeling fine and "this usually happens when I get my flu shots too". Repeated blood pressure and went to 146/77 and is feeling better. patient denied dizziness, left at 1107.
Diffuse rash began 2 weeks after first vaccine. Rash continues to grow/spread. Covering her back/abdomen/trunk, arms, legs, and now face. Very itchy.
Patient's father called into the office around 1:00pm on 2/16/21 stating that patient has broken out in hives across her chest and abdominal area.
The day after receiving my booster shot I ended up in severe back pain. I went to urgent care and was told I was having a muscle spasm in my back, something I?ve never experienced. I had to be put on a muscle relaxer for relief. From there I was sore but okay feeling until later that week five days post vaccine I developed dyskensia and my speech has been affected with no improvement. My muscles tremor and contract and I?m unable to properly speak. I have tachycardia often and constant tremors. Spasms now and then still. It?s affected my joints(joint pain) mostly bilateral knees. It?s difficult to walk as my right foot now keeps going tingly and numb. I stumble over my words and my muscles are sore from trying to force words out all day.
Migraine; joint pain; muscle pain; body ache; joint stiffness; muscle stiffness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 03Apr2021 at 10:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy, asthma, atrial fibrillation and tomato allergy from an unspecified date. Concomitant medications included gabapentin (MANAFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN methocarbamol (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took INDOCIN, TAGAMATE, ALEVE, phenobarbital (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00 the patient experienced migraine, joint pain, muscle pain, general body pain, joint stiffness, muscle stiffness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events migraine, joint pain, muscle pain, general body pain, joint stiffness, muscle stiffness was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Patient is a 23 y.o. male with no past medical history who presented to hospital 8/22/2023 with shortness of breath found to AHRF due to COVID, positive Mono and Strep A pharyngitis, discharged on decadron and amoxicillin to complete full 10 days.    1. Acute Hypoxemic Respiratory Failure: 2/2 to confirmed positive COVID and Strep A. No PE. No prior oxygen requirement, requiring 2L since admit. Significant cervical adenopathy. No stridor on exam. VBG and lactate normal. WBC 15. CT PA and CXR consistent with covid. Home O2 eval without qualification.  2. COVID pneumonia: Confirmed positive 8/22. Symptomatic x 4 days. S/p solmedrol 60 mg 8/22. No remdesivir due to LFT elevation. Tesslon pearls for supportive care.  Decadron x 10 days. 3. Strep A: Appears to have been prescribed amoxicillin outpatient and started on Unasyn in ED. Transitioned to oral Amoxicillin 8/24 to complete full 10 days. 4. Positive Mono spot: supportive care, oral hydration / nutrition. 5. Sepsis POA-  related to #2,#3, #4, supportive care, antibiotics, steroids with improvement. 6. Hyponatremia: Unclear etiology. In the setting of poor oral intake and acute infection. S/p 1 L NS bolus in ED w/ 24 hrs of maintenance fluid, normalized 7. Elevated Liver Enzymes: Unclear etiology. Likely 2/2 to recent increased alcohol intake. Last reported drink 8/18. No abdominal pain. Repeat CMP as outpatient to ensure resolution.
This spontaneous case, initially received on 24-Oct-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On 14-Oct-2016, the patient received AFLURIA with Pharmajet Stratis needle-free injection system. Dose regimen: Not reported. Batch number: not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced bruising at the site of injection (outcome: not recovered / not resolved). It was reported that no death occurred, no serious injury occurred. Reporter's assessment: It was reported that it appeared to be bruising from local site reaction to the vaccination and should dissipate on its own in several days. It was not device-related. Follow-up information received 28-Oct-2016: The patient was 61 years of age at the time of vaccination. AFLURIA was administered via the intramuscular route. Site: Right arm. The patient states that the PharmaJet did not work in her left arm, then her right arm was used. On 17-Oct-2016, the patient's arm showed bruising at the site of injection after PharmaJet used and she experienced a bad bruise on her right arm / bruise on arms (outcome: recovering resolving). Reactions are getting better now. The injection was given at work place. The patient has not gone to doctor.