chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The medication was very painful. I could feel the fluid in my arm causing severe pain.  I called my doctor on 10/3 & she suggested an ice pack with Ibruphrophen every 4 hours/24 hours.   I went to a Med Center on 10/15 because it was still painful, swollen, warm to the touch, & red. They prescribed Benedryl & a daytime allergy med.   on 10/18 I went to my doctor?s office & saw Dr who prescribed physical therapy which I?ve been to 4 times. On 11/10 my doctor prescribed Lidocaine patches which I am using. Also on 11/11 I had an Ultrasound ?. O blood clots found.
Hospitalized (1.22.22 - 1.30.22); COVID-19 positive (1.18.22); Fully vaccinated PLUS booster Admission Date: 1/22/2022 Discharge Date: 01/30/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: DKA, type 1, not at goal (HCC) [E10.10] Type 1 diabetes mellitus with hyperglycemia (HCC) [E10.65] Intractable vomiting with nausea, unspecified vomiting type [R11.2] COVID-19 [U07.1]  HOSPITAL COURSE: 27-year-old female with history of diabetes mellitus and gastroparesis presented to Community Hospital with complaints of intractable nausea and vomiting.  She had been tested on January 18 and was found to be COVID positive.  She was managing at home until worsening nausea and vomiting led to her presentation at the hospital.  During her hospital stay she had persistence of her nausea and vomiting and only very gradually was able to show signs of improvement.  Multiple times she was on IV insulin due to little to no oral intake.  She gradually did show signs of improvement with use of antiemetics and by the day of discharge felt that she was able to manage reasonably well at home.  She was discharged under usual anti nausea medication as well as her usual insulin dosing.  She number required significant treatment for her COVID infection.  She did not need steroids or other intervention. She had high blood pressures during hospital stay and was started on oral lisinopril 5 mg daily at discharge.  She is instructed to follow up with her primary care provider within the week post discharge.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On 26-Jan-2021, the parent received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Jan-2021, the elderly was diagnosed with PAIN IN EXTREMITY (Sore arm). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported by reporter.    Reporter did not allow further contact
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously in the tricep area (drug administered at inappropriate site). It was reported that the recommended area was the deltoid region. No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Tested positive for COVID; Headache; Cough; sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), COUGH (Cough) and COVID-19 (Tested positive for COVID) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PHENTERMINE HYDROCHLORIDE, TOPIRAMATE (QSYMIA) and PAROXETINE.    On 22-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Dec-2020, the patient experienced HEADACHE (Headache) and COUGH (Cough). On 01-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID). On 23-Dec-2020, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, HEADACHE (Headache), COUGH (Cough) and COVID-19 (Tested positive for COVID) 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.   No treatment information provided.
Information has been received from a health professional concerning a patient who was vaccinated with Rotateq. Subsequently, the patient received the second dose of Rotateq late, the dose was given 28 weeks and 1 day after the initial dose. Unspecified medical attention was sought. Additional information has been requested.
Moderna COVID-19 Vaccine EUA.  Intense deltoid pain started that evening and lasted for 2 days. Ongoing occasional intense deltoid pain.
1/30/21 patient felt dizzy, had a fever and nausea with some confusion so stayed at work for awhile due to not feeling well enough to drive home.  Became worse during the night and was sent to the hospital ER.
3 year old patient was inadvertently administered a third dose of Havrix today on 9/28/23; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   Previously administered products included Havrix (received the first dose on 13-OCT-2021) and Havrix (received the second dose on 14-OCT-2022).   On 28-SEP-2023, the patient received the 3rd dose of Havrix. On 28-SEP-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: 3 year old patient was inadvertently administered a third dose of Havrix today on 9/28/23).  The outcome of the extra dose administered 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: 28-SEP-2023 The reporter was Medical Assistant. The reporter called to inquire how to proceed and what to look for. The reporter explained the first dose was never recorded so they thought the patient only received one dose. Then healthcare professional noticed the first dose was administered after this extra dose was given in error. The reporter did not consent to follow-up. The patient received the 3rd dose of Havrix, which led to extra dose administered.
itches which last 9-10 days / itchy; COVID arm / Red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches which last 9-10 days / itchy) and ERYTHEMA (COVID arm / Red and itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (itches which last 9-10 days / itchy) and ERYTHEMA (COVID arm / Red and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at a dose of UNK dosage form. At the time of the report, PRURITUS (itches which last 9-10 days / itchy) and ERYTHEMA (COVID arm / Red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unspecified blood pressure medication and 7 other medications that the patient didn't want to specify.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: liver transplant (17 years ago. Patient had given birth to a second and it was something to do with the bile ducts of liver, they became exposed. It became known after patient gave birth that had this disease. Within 7 years patient was too toxic in body and had to find a donor. Patient's body rejected the first transplant and had a second transplant), and covid (Patient had COVID in 2019), and other pre-existing medical conditions included: The patient had never been hospitalized. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included sirolimus for liver transplant.  On an unspecified date, the patient experienced suspected covid-19 infection. Laboratory data (dates unspecified) included: Laboratory test not reported, and Protein total high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
PT STATES THAT THE FOLLOWING DAY SHE STARTED TO EXPERIENCE ABDOMINAL PAIN, DECREASED APPETITE, BLOATING, ACHES, AND SEVERE PAIN. STATED THAT SHE HAD RECEIVED INJECTION FOR XOLAIR 1 TO 2 WEEKS PRIOR TO VACCINE AND HAD A HISTORY OF MODERNA COVID VACCINES. SHE WENT TO HER DOCTORS OFFICE ON THAT FRIDAY FOLLOWED BY A HOSPITAL VISIT THAT SUNDAY. CURRENTLY WORKING WITH PCP AND GI RE SYMPTOMS AND HAS BLOOD WORK AND A SCOPE SCHEDULED
patient that is under 50 years old received the first dose of Shingirx; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2021, the patient received the 1st dose of Shingrix. On 27th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient was under 50 years old received the first dose of Shingirx, which led to inappropriate age at vaccine administration. No further information was reported. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054978:same reporter US-GLAXOSMITHKLINE-US2021042056:same reporter US-GLAXOSMITHKLINE-US2021030891:same reporter
The client stated that 3 hours after receiving the second COVID vaccine Moderna she developed nausea, sweating, and headache that lasted 24 hours.
Around 7-10 days after the 2nd Pfizer Covid vaccine I began to develop severe muscle and joint aches. Along with this I also began to experience tinnitus. At first the tinnitus was subtle but over the past 4 months it has become extremely bad. I have never had any ear or hearing issues, never had tinnitus and have extremely good hearing all my life.
Hives and wheezing. Received shot in morning; went to hospital at 12:30AM; received cortisone shot and allergy pill to take at home.
10-15 minutes after receipt of influenza vaccination to his right deltoid, he developed a "bright red rash to left arm" described as a flat pink rash to left hand, fingers, forearm, arm and swelling to left hand only. This rash did not itch and there was no other systemic or anaphylactic-like symptom. Pt had been on VICODIN and FLEXERIL for herniated discs. He denied any new food, clothing, soaps, detergents, shampoos, medications, etc. Oral BENADRYL provided partial resolution of rash. The rash spread to his left chest/back shoulder region later that evening. Left arm rash was resolved 24 hours later and the rest of the rash resolved within the next 48 hrs. There was no focal reaction at the vaccination site on his right arm. No brand name for the influenza vaccine given was recorded. A year later he received FLUZONE in his left deltoid. He reported approximately 10-15 minutes later he felt "his skin was on fire" and that his "body was burning and itching". He was unsure if his skin was red or not and there was no documentation in this event in his medical records. He again denied any new foods, exposure to chemicals, lotions, cleaning agents, clothing, fumes, medication, etc. He received two shots of BENADRYL 45 minutes apart, sleeping for 2 hours and awakening with resolution of symptoms. He has not had any reaction similar to this since and not with any other vaccinations.
pt had severe cold symptoms, and on the second day, work to parasthesia of right lower extremity, with drop foot.
Patient was given 0.5ml instead of 0.25ml of booster 3rd dosage vaccine, patient called on 1/18/2022 and denies any probllems since vaccination. Letter sent to patient informing of dosage given.
This spontaneous report as received from a health care worker (pharmacy technician) refers to a patient of unknown age and unknown gender. On 20-MAR-2015 the patient was vaccinated with an expiry dose of ZOSTAVAX (lot # K000996 and expiry date: 13-MAR-2015). No adverse experience was observed or reported. No product quality complaint was reported for ZOSTAVAX. Additional information has been requested.
Had high pitched shrill inconsolable crying from 10:30 AM-3:00 PM. Ran temp of 101 degrees. Mother took child to Dr office where they recommended she be monitored.
she is having sinuses; it happened at night time as soon as night comes, my nose are close; because there is no way I can't take sleep like that; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8737) via an unspecified route of administration, administered in arm left on 26May2021 (at the age of 56 years) as 1st single dose for COVID-19 immunisation. Medical history included hyperactive sinus from 2007 about roundabout for a while. Patient stated no family medical history of sinuses. The patient's concomitant medications were not reported. On an unspecified date in May2021, last night the patient had sinused and she took Sudafed. Patient enquired if it was okay that she had Sudafed in the dose of Pfizer Vaccine will this interfere wanted to know more information about this situation. Patient wanted to know if this was gone a affect her vaccine in any way that she took Sudafed other day, because she was going to watch tonight and see what happens tonight, If she can take another one or not. Patient informed it happened at night time as soon as night comes, her nose are close. Patient know it's not from the vaccine, that's just something that happens. Patient just wanted to make sure it was okay with taking Sudafed because she read about taking any Ibuprofen or any Tylenol prior to take a shot. Patient was not able to take sleep like that, so that's why, she just wanted to make sure that's okay. Patient clarified she did not have any sinus at the time of vaccination, just that night and this was something that happened all the time, not all the time whenever feels up, it just happens every now or then it just happened that night. Patient informed that the second dose will be on 16Jun2021. As therapeutic measure patient took Sudafed pill orally night only as per needed. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Returned 2 days later with erythema, swelling, slightly firm, itchy at injection site.
Shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Respiratory abnormality, unspecified.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  Reporter denies reporting this case or this patient. They stated that they have not been in practice for two years.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 and contains no new information.
(102) fever, right leg pain-not weight bearing; present at 2 days follow-up-pending.
This was the second dose given 2 weeks after the first dose. Itchy rash and hives and swollen eyes 2 days after vaccine.
Information has been received from a healthcare worker referring to unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The healthcare worker reported the following dates of administration for doses of VAQTA (lot # L043209, expiration date 17-SEP-2017, dose and frequency unknown) that were improperly stored (incorrect product storage). The vaccines were exposed at 30 Fahrenheit (F) for 13 hours on 01-APR-2016 due to digital data logger and back in store range after that. There was no previous temperature excursion. No adverse effects reported. Dates doses were administered: 13-APR-2016 one dose, 18-APR-2016 two doses, 19-APR-2016 one dose, 20-APR-2016 one dose, 27-APR-2016 one dose, 28-APR-2016 one dose, 02-MAY-2016 two doses, 03-MAY-2016 one dose, 04-MAY-2016 one dose. Additional information has been requested.
Became diaphoretic, pale, clammy, faint B/P 111/71, HR= 50  Stated feeling dizzy, ringing in ears, unable to remain alert/focused. LOC intermittently for several seconds for about 10 minutes total time
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Seizure-Mild.
Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain 5 minutes after the first dose of Pfizer coronavirus disease vaccine. MRI C spine negative for COVID related transverse myelitis.  CT head negative.  His glucose was also low that was treated. He felt better the next day and was discharged.
This initial spontaneous report was received from a physician referring to a currently 23 year-old female patient. There was no pertinent medical history or drug allergies/drug reactions described. On an unspecified date in 2010, the patient completed the GARDASIL series (dose, route, frequency, dates of vaccinations, lot# and expiration dates were not reported). There was no concomitant medication described. On an unknown date after receiving GARDASIL, the patient developed low grade squamous intraepithelial lesion. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the event was unknown. The relatedness between the event to GARDASIL was not reported. Additional information is not expected as there is not consent to follow up.
This spontaneous report was received from a physician via a company representative and refers to a currently 15-year-old female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9, injection, intramuscularly for prophylaxis (dose, lot# and expiration date were not provided). On an unknown date, the patient developed uveitis. The patient visited her doctor and she received a treatment with steroids and chemotherapy (brands and manufacturers were not provided), which was continued at the reporting time. The patient did not recover from the event at the reporting time. The causal relationship between the event and GARDASIL 9 was not provided. Upon internal review, the event of uveitis was considered to be medically significant.
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown.  Information on the lot/ batch number has been requested.
Injection site of ZOSTAVAX given in the back of the left arm SQ is very red, warm and there is a hard lump (feels 100% fine other than her arm).