chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12:30 pm - Itching noted to upper back. 12:40 pm - Developed hives to back, back side of arms, around torso. 12:45 pm - Zyrtec 10 mg taken 1:30 pm - Developed chest tightness, congestion, coughing and shortness of breath. 2:00 pm - Itching subsiding, hives unresolved for an additional hour or two.  Continued taking Zyrtec for three days due to continued coughing, congestion, and shortness of breath. Symptoms all resolved by 01/09/2021.
Patient was given a booster dose of Pfizer,however, the patient is 2.5 months form her 18th birthday in violation of 18 and above requirement for boosters.  No negative reaction to booster has been reported by patient yet just a violation of age restriction is reason for this report.
Started having fever like symptoms 12 hours after vaccine, chills and whole body shakes started shortly after, spiked a fever of 101, had emesis events x 2, fever lasted until noon on 1/21 before it came back below 100.
cold sore on lips; This case was reported by a consumer and described the occurrence of cold sores lip in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (the patient had cold sore 30 years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown.   It was unknown if the reporter considered the cold sores lip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got first shot of Shingrix and experienced cold sore on lips next day after the shot.  The patient had cold sore 30 years ago, and patient, thought it was connected.  The patient was surprised to see that cold sore was not included into side effects list.  The patient asked if these two viruses were similar? And it would be worse after second dose?
Large red area on right arm where vaccine was given. Patient also complains of pain from shoulder to elbow.
I developed a HPV wart in my nose. I do not have any history of warts at all. I did have chickenpox once in my 20's
Patient is a 62 y.o. female patient of  CNP with history of copd presented to Hospital with sob   Outpatient Pulm Summary 62 y/o female with very severe COPD and chronic hypoxemic respiratory failure.  She also is heterozygous for alpha-1 anti-trypsin deficiency and has been tobacco free for over a year.  She continues on Symbicort and Spiriva along with prn albuterol.  She is very limited from a functional status standpoint.  She is dyspneic from room to room and no longer does any house work.  Her primary goal is to control her symptoms.  She does report significant anxiety for which she has been on short acting benzodiazepines.  She was recently started on buspar as well by her PCP.  She is worried it will not control her anxiety.  I did review her overall code status which she confirmed was DNR and that she would not want mechanical ventilation.  Her shortness of breath is continuous.  She has a chronic non-productive cough .    Per pulmonology she is hospice appropriate but the pt is not ready yet.    Quite dyspneic at baseline.  Very short of breath with moving around her house.  She has Palliative Care following her and continues on her Norco and Xanax.  She is on prednisone, Symbicort, Spiriva, and nebulizers. She refuses BiPAP and states that she is not ready for hospice.  The pt also tested positive for COVID on 11/11. Negative for Flu   COPD exacerbation END stage COPD Acute on Chronic Hypercapnic respiratory failure Per pulmonary notes patient is quite dyspneic at baseline At this time patient is following with palliative on Xanax and Norco.   Pt to consider hospice. But is not ready for hospice.   She does not want routine ABGs for hypercapnic respiratory failure PCO2 94.  Now tolerating AVAPS. Pulmonary has signed off. Continue Symbicort Spiriva along with albuterol every 6 hours. Discharged on AVAPS at nighttime.   COVID 19 infection Noted CXR on 11/13 consistent with COVID and COPD.  On remdesivir and Decadron for 6 days. Was seen by ID. Discharged on prednisone home dose 10 mg daily. Continue 4 L nasal cannula   Hyperkalemia- resolved. K 6.0 on 11/13, sample Hemolyzed.    Hyperkalemia- resolved. K 6.0 on 11/13, sample Hemolyzed.     Pallative Patient under palliative Cont norco and xanax. Per the pt she is not ready for hospice. .
Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Systemic: Other- sob-Medium
Pt recvd 3 doses of Engerix-B & exp no medical problems or reactions; titer results indicated no antibody conversion;
Patient remained in the store after receiving his second Shingrix dose. He did not have a reaction to the first dose. About 10-15 minutes after the dose, he returned to the pharmacy counter complaining of dizziness. He was also breathing heavily. I had him sit down and elevated his feet. I took his blood pressure and it was around 180/110. I continued checking it every 10 minutes for 40 more minutes. It remained elevated between 178/114 and 196/118. The patient had another dizziness episode after about 30 minutes. EMS was called. His blood pressure eventually dropped to less than 160 and the patient was able to stand up and left on his own.
Event occurred after 2nd dose. patient is a 67-year-old female with extensive mass past medical history including asthma, diabetes mellitus type 2, obesity, pulmonary hypertension, anxiety and chronic pain who presents to the ED due to a 1 week history of shortness of breath.  Discharged
Fever of 101, chills, body aches, tired, arm pain.  Fever last for about 10 hours,  felt better by early morning on April 28th.
post vaccine observation session, patient complained of throat tightness/trouble swallowing and voice became raspy. patient has multiple reported allergies and carries epipen. Received 2 doses of epi IM and one dose Benadryl prior to arrival in EC, for throat and tongue swelling again.  At triage, sleepy, on transfer to floor became unresponsive and noted to be seizing (received 3 doses ativan) with no resolution, subsequently intubated for airway protection and transferred to ICU.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported
On 6/27/22 9 year old pt received a Moderna Magenta dose of Covid 19.  Spoke/emailed CDC Ask the Experts as well as Moderna.  Both stated pt can come in and receive the age appropriate Covid 19 vaccine.  We do not have Moderna Teal as of yet so if pt can come in soon pt would receive Pfizer for 5-11 year old.  Or can wait unit we receive Moderna Teal.  Spoke mother on 6/28 informed her of the incident, mother calm and understanding.  Informed her of the 2 options that were advised.  Mom states she will need to speak with dad and call us to let us know what they decide.  Also, left a voicemail on dads number to call clinic.  No treatment is needed, will have to start Covid 19 vaccine over.
Information has been received from a physician concerning a 6 month old male who on 16-NOV-2007, 25-JAN-2008 and 20-MAR-2008 was vaccinated PO with his first, second and third 2.0 ml dose of Rotateq. On 20-MAR-2008 after vaccination, the baby was acting strange and irritable and was taken by the parents to a hospital emergency room twice. Both times the baby was sent home with no conclusive diagnosis. The symptoms continued and the parents called the physician and the baby was taken to a different hospital. The patient was admitted to the hospital and underwent surgery for intussusception. On 08-APR-2008 the patient was seen for follow-up after hospitalization. The outcome was unknown. There was no product quality complaint. Intussusception was also considered to be an other important medical event (surgery) by the physician. Additional information has been requested.  9/22/09 Vaccine records received. According to records doses of rotavirus vaccine were administered IM in thigh.   9/25/09 Hopsital records received DOS 3/30/2008 to 4/2/08. Assessment: Incarcerated, strangulated, intussusception (ileoileal). Patient was seen in ER and discharged, returned with worsening pain, decreased PO intake, persistant vomiting and bloody diarrhea, increased lethargy. Abdomen distended. Unable to reduce intussusception with air contrast enema. Admitted to PICU after distal ileal resection and appendectomy.  ICD-9 Codes: 560.0 Intussusception, 557. Ac Vasc Insuff Intestine.
She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second; She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second".  Clinical course: She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second, and by then (Dec) no one had it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediate itching. Upset stomach. Headache. Body aches and pains.  Right lower leg felt like it was broken. Pain at an 8. Couldn't walk for 15 minutes. Exhausted.  Dry mouth.
received the first dose /on 11/11/2019 and wasn't able to get in to get second dose; This case was reported by a pharmacist via and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th November 2019, batch number 95R52,expiry date 10th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The pharmacist reported that patient was not able to got in to get the 2nd dose.  The pharmacist had concerns of how to proceed with second dose since it was over a year. The reporter did not consent to follow up. The healthcare professional (HCP) stated after call would provide patient with medical information received and would see how patient would like to proceed.
Right axillary lymphadenopathy/pain  one day after 2nd vaccination x3 days. Resolved.
This spontaneous report as received from an 78 year old female patient with high cholesterol, high blood pressure and allergies to sulfa. On 21-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot # and route were not reported) in the left arm. Concomitant therapies included NEXIUM and unspecified cholesterol blood pressure medications. On 12-JUL-2013, the patient experienced right eye swollen and right side of the face was also red and swollen. The patient wanted to know if the events could be a side effect of the ZOSTAVAX vaccination given on 21-JUN-2013. Blood work up was performed in June 2013. The patient did not seek medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
pt recv vax & devel a fever of 103, aches, chills, nausea & dry heaves; No further details were provided;
This spontaneous report as received from a physician refers to a 7 year old child patient. Current conditions and medical history was not reported. On 03-DEC-2014, the patient was vaccinated with GARDASIL injection, 0.5 milliliter, intramuscular. Concomitant medications were not reported. On 03-DEC-2014, 7 year old patient was vaccinated with GARDASIL injection. No adverse effects were reported. The outcome was unknown. Product quality complaint was not reported. No further information was provided. Additional information has been requested,
Developed rash on left armpit and back first noticed on Saturday December 1st.  Emergency Room visit was made and shingles was diagnosed by visual assessment.  Prednisone and another medication was prescribed.  Child also having recurring ear infections, bronchitis, and possible MRSA infection for 1 month or so before shingles diagnosis.
On 2/4/2021 @ 11:10 am, 2nd  Moderna Vaccine,  Lot Number 057G20A, administered at the Facility. (First shot administered at same location on 1/7/2021.)  Feb 5, 2021,  3:46 am Temperature 100.4. feeling unwell   7am  Temp: 102.2, nausea, extreme achiness in muscles and joints, base of spine, headache, tired, swollen lymph nodes;  redness, hardness and swelling at injection site plus the site felt very warm. Felt extremely sick. Sicker than a bad flu.  9:30 am Temperature 102.7. Husband reread handout on side effects and thought I should not take medication to reduce fever. I asked him to read it because I couldn't think well. I decided to take 500 mg of of acetaminophen at 10 am.   10:25 am temp 100.4 11:30 am temp 101.3   Took 500 mg more of acetaminophen 12 noon Temp 100.4 2:57 pm  Temp 100.7 5 pm Temp 101.4 feeling very weak tired, nauseous, achy all over 6:24 pm Temp 102.5    Took 500 mg of acetaminophen 7:14 pm Temp 100.0 9:28 pm Temp 99.5 Feb. 6, 2021 12:55 am (00:55) Temp 101.8   Very nauseous achy, Took 1000 mg acetaminophen 10: 05 am Temp 97.5   a normal reading for me. BP 141/83, a bit high.  Feb. 7, 2021  12:38 pm it was 117/81 which is normal for me lately. Temp 98.6.
three "bypass" procedures; aortic valve replacement; 99 days have past since first dose in the series; This spontaneous case was reported by a pharmacist and describes the occurrence of VASCULAR GRAFT (three "bypass" procedures) and AORTIC VALVE REPLACEMENT (aortic valve replacement) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VASCULAR GRAFT (three "bypass" procedures) (seriousness criterion hospitalization), AORTIC VALVE REPLACEMENT (aortic valve replacement) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (99 days have past since first dose in the series). At the time of the report, VASCULAR GRAFT (three "bypass" procedures), AORTIC VALVE REPLACEMENT (aortic valve replacement) and PRODUCT DOSE OMISSION ISSUE (99 days have past since first dose in the series) outcome was unknown.        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.   Concomitant medications were not reported. Treatment information in response to events was not provided.  Company comment: This case concerns a 73-year-old male who missed 2nd dose more than 99 days (MISSED DOSE).  The other events of aortic valve replacement and Bypass surgery are interventions for pre-existing conditions and as such are considered unlikely related to mRNA-1273 vaccination.  The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 73-year-old male who missed 2nd dose more than 99 days (MISSED DOSE).  The other events of aortic valve replacement and Bypass surgery are interventions for pre-existing conditions and as such are considered unlikely related to mRNA-1273 vaccination.  The event of missed dose is assessed as not applicable.
I received fever; runny nose; fatigue for 6 days and I took PAXLOVID.
Started itching a little and was sort of pink. 10/26/2012 is sore like a bruise and is red in an area about 2"x1" down from the injection site. This is not severe but thought I'd report anyway.
Lips feeling tight, itching, burning sensation like pepper feeling. (24 hrs later felt like this). Also dark spots on lips. Not yet going to ER.
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: isopropanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Vaccine didn't work, still got shingles/Suspected vaccination failure; Shingles; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-NOV-2022 Reporter's Comment: The patient self-reported this case via interactive digital media and described the occurrence of suspected vaccination failure. The patient stated that the vaccine didn't work for him/her. He/she still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Experienced very severe tinnitis after 2nd shot.  Continuing from beginning March until now.  We participate in Vsafe, but did not report this because we did not realize it might be related to the 2nd shot.  Therefore, reporting through this systen,
9 days later (02/21/2010) centered on vaccination site:  Erythema, swollen raised itchy rash, warm to touch,  approximately 2 inches by 3 inches appeared . Over several days, itching reduced , grew to 2- 1/2 inches by 3- 1/2 inches with well defined raised border. Rash started fading by 10 days later (03/02/2021)  and was mostly gone by day 13 (03/05/2021).
Provider Summary: "79 YO female with history of Type II Diabetes, HTN, HLD, CVA, and breast cancer presenting from hospital with fever, cough, fatigue, and several recent falls. On presentation to the ED the patient was hypertensive and febrile and saturating at 94% on room air. She was found to have sepsis secondary to COVID-19 infection. She had an elevated lactate of 4.1 and a mild anion gap of 16. A CT head demonstrated no acute intracranial abnormality. There were senescent changes as well as old infarctions present. A chest x-ray demonstrated no acute disease. The patient was started on a three day course of Remdesivir as she was not hypoxic at the time of admission but had risk factors for severe disease. She soon required 2L nasal cannula for respiratory support. She was started on Decadron and her course of Remdesivir was extended. With initiation of steroid, hyperglycemia was anticipated and insulin was titrated up appropriately. The following day the patient was no longer requiring supplemental oxygen support. She was feeling back to her baseline aside from her productive cough and fever free for >48 hours. She was treated with an additional day of Remdesivir and Decadon and she was discharged home on her home medications with glucometer and appointment with her primary care physician."
Rash developed approximately 2 weeks after vaccination. Rash is located about 6 inches above right wrist. Rash is raised and is itchy.
This spontaneous report received from a patient concerned a 65-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, controlled high blood pressure, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced became slower at work. On 2021, the subject experienced felt really weird. On MAR-2021, the subject experienced constantly sleepy. On 13-MAR-2021, the subject experienced very tired. On 15-MAR-2021, the subject experienced fog/not remembering conversations, directions, not as conscious about her work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constantly sleepy, became slower at work, and felt really weird on MAY-2021, and fog/not remembering conversations, directions, not as conscious about her work, and very tired on 08-MAY-2021. This report was non-serious.
L thigh redness of 1cm diameter & small papular lesion in center.  No fever.  These occurred about 48 hrs after shot.  No treatment.
Around 11am the 23rd I starting having chills, low grade fever, severe body aches. Went to walk in clinic (Urgent Care) around 6pm that evening and had Covid and Flu test, both came back negative. Body aches lasted thru the night had to take medicine, body ache and head ache last two days.
Patient received a booster dose of Moderna in the amount of 0.5mL vs. 0.25mL
My mother received doses of the Pfizer vaccine.  She received the first shot on Friday March 5, 2021 at 12:15 PM and the second vaccine on Friday March 26, 2021 at 11:45 AM. Both vaccines were administered at the pharmacy. Early Tuesday Morning she was incoherent and suffered a stroke. She was taken to the hospital  and spent the entire week  at the hospital. Her primary doctor,  was out of town and Dr was the covering doctor. While in the hospital she was under the care of another Dr