chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated 2/3/2021 and 3/3/2021 and tested positive for Covid-19 on 6/11/2021.  Client is Asymptomatic.  Sample will be sent for genomic sequencing.
Development of right arm itching and redness at injection site approximately 8 days s/p immunization. Treatment with Benadryl 50mg PO x 1 on day 2 of reaction and Augmentin 875mg PO bid x 10 days (started on day 2 of reaction; currently on day 6 of Augmentin Tx).  Slow central clearing started within the area of skin redness within 24-48 hrs s/p initiation of oral medications with almost complete resolution of redness within about 96 hours of Tx. Residual itching remained for approximately 5 days even after reduction of skin redness. Only a very minimal amount of muscle soreness developed on day two of the skin eruption and subsided within about 24-36 hours. Sx isolated only at the injection site. No systemic Sx.
Fever 100-101 degrees F; Severe chills at night; Irregular urination; Rusty colored urine; Fatigue; Kidneys felt sore; This is a spontaneous report from a contactable other healthcare professional reported for himself. A 32-year-old male patient received first dose BNT162B2 (reported as PFIZER BIONTECH COVID 19 VACCINE, Lot number: EL3249, Vaccine location: Left arm), via an unspecified route of administration on 16Jan2021 15:45 at single dose for covid-19 immunization.  The patient had no medical history. The patient did not have allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Roughly four days after vaccination (21Jan2021 04:00 AM) the patient developed a fever 100-101 degrees F, severe chills at night, irregular urination (including rusty colored urine), fatigue, and his kidneys felt sore. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient did not have been tested for COVID-19. The patient was not received treatment for the adverse events. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the events was resolving.
I just did not feel well for a couple of days. I was tired, body aches and nausea 5 to 6 month later I got COVID.
above/below temp excursion / Might have administered to pt during the excur period; This case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in a unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Havrix, Shingrix, Boostrix and Engerix B. On an unknown date, unknown after receiving Havrix, Shingrix, Boostrix and Engerix B, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse was unaware of above or below temperature excursions that happened since January 2021. Temperature excursion information was reviewed and the cumulative time of exposure was 30 hours, which led to intercepted product storage error. The vaccines that were administered were still viable. The consent to follow-up was granted.
Swelling; Sensitive; Headache; general malaise; chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2019, the patient received the 2nd dose of Shingrix. On 9th June 2019, less than an hour after receiving Shingrix, the patient experienced swelling. In June 2019, the patient experienced headache, general malaise, chills and injection site hypersensitivity. On an unknown date, the outcome of the headache, general malaise and chills were recovered/resolved and the outcome of the swelling was unknown and the outcome of the injection site hypersensitivity was not recovered/not resolved.   It was unknown if the reporter considered the headache, general malaise, chills, swelling and injection site hypersensitivity to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that she received Shingrix vaccine and developed a headache, experienced general malaise, and chills on and off through and then these symptoms resolved.   She also had swelling below the injection site that started within an hour of receiving the vaccination.   At the time of reporting, the injection site was sensitive. The reporter consented to follow up. This case has been linked with case US2019106971, reported by same reporter.
L rash, hematoma approximately 2 in diameter rash - demarcated erythema approximately 5 in diameter.
Developed hives 30 minutes after Vaccine, administered PO Benadryl observed an additional 30 min. and hives resolved.
no adverse event; improper stored vaccine was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-MAR-2021, the patient was vaccinated with an inappropriately stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 milliliter, lot # S037820 expiration date 24-NOV-2021, albumin status: rHA; route of administration not provided) for prophylaxis.  It was reported that the vaccine had a temperature excursion at 11.7°C for 75 minutes due to a data logger issue.  There were no previous temperature excursion and no adverse events were reported.
The symptoms lasted 14 hours and included fever of 100.9, chills, headache, muscle and joint pain, cramps in calves and feet
Did not return for their 2nd dose after 28 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
Fever and chills for 24 hrs, swollen lymph nodes in armpit of injection site still ongoing
Patient had a heart rate above 100 for more than a minute. then went back to normal. patient did not faint.
A sales representative reported that a 2 year old child received an injection of Prevnar on 3/9/00. Later that day, the child developed a rash. The rash worsened and became generalized on 3/10/00. No further information was available at the date of this report.
Information has been received from a health professional concerning a 4 year old male, with no known medical history of allergies, who on 5/30/2001 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that the patient was seen on 5/5/2005 for a rash that began 1 day ago, on 5/4/2005. The rash was described as red and spreading, located on his neck and chest. There were no complications. The patient was treated with Avena Aveeno bath and diphenhydramine hydrochloride Benadryl for itching. On 5/5/2005 the patient recovered. There were no laboratory or diagnostic tests performed. Follow up information from a health professional indicated that on 5/4/2005 the patient developed a rash located on his neck and chest. The rash was red and spreading. It was diagnosed as a varicella rash by the physician. The patient was reported as recovered on 5/5/2005. Additional information is not expected.
Sedation, Arthralgia, Fever, Diarrhea & NauseaVomiting Narrative:
Red Swollen and hot injection site, Hives on neck bilateral and under Left breast and rib area.
Have a little redness & bruising at injection sight (upper left arm).  Left arm was sore late in day of injection.  Early morning of 3/26/2021 I had numbness & tingling in left hand which kept me awake on & off all night.  Was extremely tired when I woke up.  Later in the day on 3/26/3021 had a rash around elbow bone.  Starting to fade now (early 3/27/2021).  Mainly concerned if this was an adverse reaction & if it would affect effectiveness.
This spontaneous report was received from an unspecified source, concerning unspecified girls from unknown ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was reported that on unspecified dates, an unknown number of girls experienced multiple sclerosis and encephalitis, (also reported as ''brain inflammation''), after vaccination with GARDASIL. The outcome of the events was not mentioned. The relatedness between 'the events and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1507ZAF012830.
Redness and swelling around site of immunization on right thigh. Treated with AUGMENTIN BID for 10 days.
Initial report received from a health care professional on 11 September 2012. A 29 year old female patient whose medical history and concomitant medications were not reported, had received first dose of intramuscular ADACEL vaccine (Lot number: U4393BA) at right deltoid region on 07 September 2012. The patient's date of last menstrual period was 13 December 2011 and the estimated date of delivery was reported 18 September 2012. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the patient's outcome was unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon information received, this case now meets seriousness criteria and has been upgraded to serious. The patient experienced oligohydramnios. Maternal history included one previous pregnancy. The patient delivered a normal infant on 07 September 2012. Outcome was not reported. Documents held by sender: none.
Patient expired 11/15/2021.  HOSPITAL COURSE: PRESENTING PROBLEM: Shock [R57.9] Colon cancer metastasized to multiple sites [C18.9] Septic shock [A41.9, R65.21] Small bowel cancer [C17.9]  Patient is a 62 y.o. male with history of metastatic stage 4 colon cancer who presented to the emergency department with new bowel perforation of a known right colonic mass. He was hypotensive and unstable at the time of presentation. He was taken for an emergent exploratory laparotomy with a right colectomy and small bowel resection. During the case, he had increasing pressor requirements and worsening hypotension. Decision was made to transfer to the SICU and leave the patient in discontinuity with an abthera for temporary closure.    Patient was therefore transferred to the SICU. He was started on multiple pressors including norepinephrine, vasopressin, and epinephrine to maintain his blood pressure. Despite these interventions, he continued to be unstable. Family made the decision to make him DNR/DNI, however with continued aggressive care and interventions on 11/14. He continued to be on the ventilator with progressively increasing pressor requirements. On the morning of 11/15, family made the decision to transition to comfort care measures. Propofol was stopped, and pressors were stopped shortly after. Family desired extubation and patient was extubated at 0625. Time of death was 0647 on 11/15/2021  Preliminary Cause of Death: Colon cancer metastasized to multiple sites
I received the vaccine on 03/22/2022.  On 06/16/2022 about 10:00pm I started feeling sore throat , coughing, weakness and shortness of breath. I took motrin the next morning and went back to bed. 06/20/2022 i tested positive for covid.
This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9810 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 27Feb2021 (at the age of 42-year-old), as dose 2, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included penicillin allergy. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 06Feb2021 (at the age of 42-year-old), as dose 1, single, for COVID-19 immunisation. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced dry cough, was feeling chest congestion, headache, fever, tiredness and muscle pain on 28Feb2021. Patient did not receive any treatment for the events. The outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.
Patient experienced hives, sweating, extreme nausea, and vomiting on the evening that she received the vaccine. She has had a heart attack in the past. Daughter was afraid that her symptoms resembled a heart attack.
Developed Alopecia Areata 2 months after second vaccination in series.  Never before any such problems.
Fever (102): body aches, chills, nausea, lightheaded (vertigo) All symptoms have subsided EXCEPT Vertigo/dizziness
received 1st dose of Engerix on 18June2023 and is late for the 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: received 1st dose of Engerix on 18June2023 and is late for the 2nd dose.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-SEP-2023 Health care professional (HCP) was at home and did not have any patient and vaccination details other than the date. Patient received 1st dose of Engerix on 18th June2023 and was late for the 2nd dose. Till the date of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The HCP consented to follow-up via email.
Severe headaches never get headaches; Whole body aches; Fever; Diarrhea; This is a spontaneous report received from a contactable consumer or other non hcp(patient). A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO191) via an unspecified route of administration in Arm Left on 04Jun2021 at 10:30 AM (66-years-old age at vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Heart arithmia from an unknown date and unknown if ongoing, covid-19 from Jan2021 to an unknown date. Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 13:00, the patient experienced severe headaches never get headaches, whole body aches, fever and diarrhoea. I had covid in january and felt like I have it all over again. Treatment was received for the events. I called Dr and got advise on meds to take. The events was reported as non serious. The outcome of the events was reported as not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
he did not get dose 2 yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 14th September 2021 into left arm).   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 Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The patient's wife reported this case. The patient did not have any side effects after first dose but he did not get dose 2 yet. They were aware he should have gotten it between 2-6 months after dose 1. The reporter did not want to file adverse event or provided patient's information education provided per content. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to Incomplete course of vaccination. This case has been linked with case US2022063353, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022063353:same reporter
Significant swelling of L>>R anterior cervical lymph nodes. No SOB or wheezing, but given acuity and severity of swelling, she was given give epinephrine, benadryl, and solumedrol. She was monitored for 30-40 minutes after treatment.
At 12:00 PM on Thursday February 7, 2013, I checked patient's temperature and it was 100.8 degrees Fahrenheit. I gave her 2.5 ml of Children's Tylenol. I started to notice her right arm was flailing like she was having an spasms. Around 3:30 PM I called facility and made an appointment to see Dr. that same day at 4:30 PM. At 4:00 PM I rechecked patient's temperature and it was 99.1 Degrees Fahrenheit. I brought her to see Dr. who was unsure why her arm was flailing like that. I was then advised to give it a couple of days to see if it would subside and if it did not stop come Monday February 11, 2013 to contact the Neurology Department of Hospital. She continued to flail her arm the rest of the day. The next day Friday, February 8, 2013 after patient was still having this problem I contacted the Neurology department and spoke with a nurse who said to be on the safe side bring her in to be seen. I immediately brought her in and was seen by several doctors including neurologists and specialists. Tests were performed and we were admitted at 7 PM for further testing.  On Saturday February 9, 2013 after further testing we were discharged and waiting for pending results. Was diagnosed with Acute Chorea of February 14, 2013 with additional bloodwork ordered.
2nd dose received late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old male patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 1st September 2021).   On 19-MAY-2023, the patient received the 2nd dose of Twinrix. On 19-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-AUG-2023 The pharmacist reported that patient received the first dose of Twinrix then a late second dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The reporter consented to follow up via mail The vaccine administration facility is the same as primary reporter.
Red small pimply red rash on front of chest & under arms, itches mildly; began eve p/vax (yesterday) & peaked this AM-receding now (10AM);
Patient was administered booster dose of Pfizer Covid-19 vaccine after completing primary series of Moderna (3/11/21 & 4/8/21); he was aware he was receiving Pfizer vaccine. He claimed to have experienced dizziness after previous vaccinations. After administration, patient sat down in waiting area and was given a cold cloth after feeling hot and anxious; no observed hives or difficulty breathing. 911 was called after observing when going from hunched, seated position to sitting up straight, the patient lost consciousness for approximately ten seconds before becoming aware of his surroundings. Paramedics arrived to assess patient and he refused to be transported to hospital.
Side effects experienced included fever of 101, restlessness, deep soreness in arm, light headedness, fatigue. All symptoms began around 1AM, 12 hours after vaccination.
Case number PHEH2013US026272, is an initial spontaneous report received from the nurse on 20 Dec 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13015, expiry date: Sep 2014), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 10 Dec 2013. No adverse event was reported following this administration error.
Baby broke out in rash all over back and stomach and partial face and had swelling around area Of injection   and ran a fever for alil over a week and didn?t eat or drink anything except pedalyte  and dr & nurse said it was normal for him to be like that and to continue with Tylenol and motrin
Vertigo began the evening of 4/26. Multiple bouts of vertigo per day since then, often upon waking/going to bed, exercising, showering (hot water), or moving too quickly. Spinning and sometimes feeling close to passing out/fainting. Loss of balance with incidents. Have started taking emergen-C daily.
lt arm (upper) edematous & pruritic w/ 3" diameter erythema lasted couple days;used cool compress & DPH;resolved w/o further tx;
Only noticed a warm, raised, red area tonight, only slightly tender when touched. About 5 cm long by 3cm wide (elliptical shaped).
Swollen upper arm and the arm's warm. Lump formed on the same arm towards inner arm. Very, very sore.
Patient had a rash and discomfort on the arm the vaccine was given on later that day. 2 or 3 days later the patient had hives swelling on his legs and arms and pain at the injection site.