chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful to walk and stand; painful to walk and stand; level of pain has stayed the same since it began; joint and muscle pain; joint and muscle pain; joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments; 2 days after vaccine sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (2 days after vaccine sore arm), GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began) and ARTHRALGIA (joint and muscle pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (2 days after vaccine sore arm). On 10-Mar-2021, the patient experienced GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and ARTHRALGIA (joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments). On 05-Mar-2021, PAIN IN EXTREMITY (2 days after vaccine sore arm) had resolved. At the time of the report, GAIT DISTURBANCE (painful to walk and stand), DYSSTASIA (painful to walk and stand), PAIN (level of pain has stayed the same since it began), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and ARTHRALGIA (joint pain was mainly in his knees and the backsides of his knees running down his tendons and ligments) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. treatment medicine include Ibuprofen but not too often since it causes stomach issues for him.
-LEFT ARM PAIN WARM BUT NOT RED OR SWOLLEN, PAIN IN LEFT FOOT, LEFT SIDE OF TIP OF TONGUE NUMB AND TINGLES, PAIN IN LEFT ELBOW, LEFT RING FINGER ITCHY
At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area post vaccination.  RN obtained V/S: 122/76; pulse 78; resp 18; pupils equal and reactive; skin pink.  Employee was alert and oriented.  She reported slight reaction about 30min. post vaccination.   Dr. was notified and assess the employee.  Dr. ordered Benadryl 25mg PO at 1001.  This was administered by RN.  Employee was monitored for another 20 minutes and then was aloud to leave.  Employee was feeling better before leaving.  She was instructed to seek medical attention if symptoms returned or new symptoms occured.  She verbalized understanding.
Following third dose booster on 30-Dec-2021, patient reports HSV infection reactivation on 01-Jan-2022 with known history of HSV-1 confirmed by laboratory testing in 2005.
Shortness of breath, severe by next day, was admitted to hospital on 10/5/2011. Muscle weakness began within a week and continued to progress until January, when at it's worse had trouble swallowing, difficulty speaking, drooling, arm and leg muscle weakness, difficulty walking. Symptoms began to improve by early February, now muscle weakness is almost completely gone but still have sob, but it has improved.
September 2022 I thought I had pollen allergies, after using Claritin D and ibuprofen for several days I wasn't improving so I took an at home Covid 19 test and it came back positive. The next day I felt like I had the flu, slept a lot, had a burning throat, no appetite . This lastest for approximately 1 1/2 weeks, gradually improving
Initial misuse report received from a healthcare professional on 07 March 2013. An 11-year-old patient (no more information was provided regarding the patient) had received a dose of MENACTRA and ADACEL vaccine in August (year not specified) after the patient turned 11 year old and then received both vaccines again while he was still 11 years of age. No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a consumer (mother of the patient) and refers to an adolescent (also reported as "over the age of 15 years old") female patient. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 injection, intramuscularly in arm (exact dose, lot # and expiry date were not provided) for prophylaxis. Approximately on an unknown date in July 2018 (reported as 7 months ago), the patient missed her second dose of GARDASIL 9 of a three dose regiment. The patient did not experience any reaction.
On 10/15/2003,, administered MMR right thigh and varivax left thigh at 5:00 pm (17:00).  Approximately 17:05, mom noticed welts on both thighs at injection sites.  MD gave Benadryl 12.5 mg at 17:10.  Patient left office at 17:30.
arm was sore for 3 days. then a week later I had intense itching in my arm. It went away and then for a few weeks now I have had sudden onset of diarrhea. I have taken Imodium and it isn't working. I even tried eating a bunch of cheese.
lethargic; chills; fever (99-100); no appetite; body aches (big time); no energy; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite) and MYALGIA (body aches (big time)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite), MYALGIA (body aches (big time)) and ASTHENIA (no energy). On 07-Feb-2021, LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite), MYALGIA (body aches (big time)) and ASTHENIA (no energy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
administration twice to a 12 y/o patient; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA581A, expiry date 31st August 2022) and (batch number AMAVA581A, expiry date 31st August 2022) for prophylaxis.   On 21st September 2021, the patient received Menveo. On 21st September 2021, the dose was an unknown dose. On 21st September 2021, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information was provided as follows: The nurse reported that administration of Menveo on dates of administration of 10th Sep 2021 and 21st Sep 2021 to a  patient. The reporter consented to follow up.
The next morning after my shot, I had a lump on my right side of my neck. It is still present today. I went to my doctor and she checked it out. She also checked me for an ear infection. She gave me medicine and it did not help the lump on my neck.
This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of GARDASIL 9 lot # L043213 with expiration date 28-AUG-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
3 hours post vaccination violent vomiting, rapid heart rate, high blood pressure, abnormal ekg
Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.). On 16-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided No Treatment medication was provided.
Three days after the second dose, started experiencing severe upper G.I. issues which including severe burping, discomfort, loss of appetite, nausea, etc.
Approx. 7 hrs post Menomune injection, developed red indurated lesion at site measuring 3 inches with 3 inches of erythema surrounding it. Area itches, was warm to touch. Lasted 24 hours.
PATIENT SAID DAY AFTER SHE FELT DIZZY, HAD BLURRY VISION, NAUSEAM AND BAD HEADACHE.  THE NEXT DAY SHE WAS FINE.  A WEEK LATER ON DAYS 8 AND 9 POST VACCINE THE ABOVE SYMPTOMS RETURNED WITH A VENGENCE.  PATIENT WAS UNABLE TO GET OUT OF BED, COULD NOT READ A BOOK DUE TO BLURRY VISION.  OVER THE COUNTER MEDICATION DID NOT RELIEVE HER PAIN
Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in arm left on 01May2021 13:15 as 1st dose, single dose and patient also received other vaccination on the same day as dose 2 via an unspecified route of administration, administered in arm left on 01May2021 13:15 (Batch/Lot Number: EP5733) as 2nd dose, single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not take any other medications in two weeks. Patient did not receive any other vaccine within 4 weeks. Patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. On 04May2021 02:00, the patient experienced stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands and lumps in the neck. Patient was not received any treatment for the events. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
SUFFERING BLOOD CLOTS; NERVE PROBLEM; This spontaneous report received from a patient via a company representative via Social media which concerned a patient of unspecified age and sex The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total, administered , start therapy date were not reported 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 an unspecified date, the patient experienced suffering blood clots and nerve problem. Patient stated J and J should pay for my side effects suffering blood clots, nerve problem and Johnson and Johnson vaccine mess me up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suffering blood clots and nerve problem was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211139414 -covid-19 vaccine ad26.cov2.s- suffering blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced shingles, discomfort and painful rash. On an unknown date, the outcome of the shingles, discomfort and painful rash were unknown. It was unknown if the reporter considered the shingles, discomfort and painful rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient contacted via call back and stated that after receiving SHINGRIX vaccine, he had a full case of shingles. This rash was exceptionally uncomfortable and painful. The patient was very unhappy that there was no warning that he would actually got shingles from this vaccination. It was not mentioned as a side effect on any documentation. The patient provided the vial kit number and asked to contact him and advice on next step. The patient was contacted and the phone rang and rang and disconnected itself. Limited information was available.
Fatigue; Sore throat; Congestion; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 10Dec2021 (Lot number: FJ8757)at the age of 22 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing).Concomitant medications included unspecified birth control pills. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8732, Route of administration: Unspecified, Anatomical location: left arm), administration date: 19Apr2021, when the patient was 22 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0161, Route of administration: Unspecified, Anatomical location: left arm), administration date: 10May2021, when the patient was 22 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Dose number: 3"; FATIGUE (non-serious) with onset 05Jan2022 at 22:00, outcome "recovering", described as "Fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 05Jan2022 at 22:00, outcome "recovering", described as "Sore throat"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 05Jan2022 at 22:00, outcome "recovering", described as "Congestion". Therapeutic measures were taken as a result of fatigue, oropharyngeal pain and respiratory tract congestion.  Additional information: The patient's known allergies were reported as none. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. The patient received Mucisinex as treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Patient first reported to Nurse on 04 Jan 2021 that for the past four weeks post vaccination he had been experiencing periodic red itchy hives on legs, torso, arms, neck and face. Patient states that he believes the hives started in a window of three to seven days post vaccination. He does not report introducing any new foods, herbs, supplements, detergents lotions or soaps etc. The patient has been taking benadryl PO as needed but the hives have continued to reappear through out the last month. Patient is not experiencing any life threatening allergic response, was educated on what to look for, and instructed to go to the ER immediately if those symptoms appeared. Patient was told to make an appointment with his primary care for further evaluation, treatment, and investigation into his potential allergy.
administered dose of improperly stored VARIVAX; This spontaneous report was received from Other and refers to a 13-months-old (also reported as 14-months-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot # W002596, expiration date: 24-JAN-2024, administered in left vastus lateralis for prophylaxis (strength, exact dose, and route of administration were not provided). Prior to being administered to the patient, the vaccine experienced a temperature excursion for a total of 32 minutes. The temperature of the freezer was higher than the recommended temperature (exact temperature of excursion was not provided).
Tested positive for COVID-19; Feels very ill; Feeling tired; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling tired, feeling very ill, and tested positive for COVID-19.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 07 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient felt tired and sick.   On 13 Jan 2021, the patient was admitted to the hospital where he tested positive for COVID-19. He felt very ill.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was not reported.; Reporter's Comments: This spontaneous report concerns a male patient who experienced feeling tired, feeling very ill, and tested positive for COVID-19. The events of feeling tired, feeling very ill started one day after the administration of mRNA-1273 vaccine (Lot number: unknown, expiration date: unknown) and  6 days after the vaccine administration, the patient tested positive for COVID-19. Based on the information provided, the known etiology of the disease and the timing from vaccine administration to COVID diagnosis, a causal association between the reported events and mRNA-1273  vaccine administration is unlikely.
30 min after the injection, patient had local swelling and erythema, pain at the right deltoid as an injection site. no other associated symptoms. It took her about 7 days recovering form the swelling and the pain. today when she came to the office ,she reported the problem has completely recovered, so did the physical exam.
Patient received GARDASIL vaccine, then when performing FS for Hgb pt. became lightheaded and decreased BP 86/40. Pt. laid down, given juice, vitals monitored. Fully recovered, increased BP. Monitored for 1/2 hour then sent home.
Systemic: pt did not pass out but like....fell forward out of chair-Mild, Additional Details: Pt was nervous about vaccine... about 45 seconds after vaccine fell forward out of chair onto ground (caught himself). we called 911 and they checked him out. he was fine. no allergies, first dose was fine, no headache, didnt pass out.... pt hadnt eaten since last night.
No adverse effects reported.; VARIVAX was administered too soon after MMR II; This spontaneous report has been received from a registered nurse referring to a 20 months old patient of unknown gender. The patient's concomitant medication included sterile diluent. Pertinent medical history and drug reactions/allergies were not reported.     On 06-MAR-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot# R028225, expiration date 02-OCT-2020; dose number and route were unknown) for prophylaxis.  On 26-MAR-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R023735, expiration date 20-AUG-2020; dose number and route were unknown) for prophylaxis. The nurse reported that varicella virus vaccine live (oka/merck) (VARIVAX) was administered too soon after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of vaccine administered). No adverse effects reported. The outcome of the events was unknown. No product quality complaint presented.
Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial; patient received Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number BT479, expiry date 15-SEP-2025) for prophylaxis.   On 25-SEP-2023, the patient received Shingrix. On 25-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial) and inappropriate dose of vaccine administered (Verbatim: patient received Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that patient received Shingrix reconstituted with 2 lyophilized vials and 1 adjuvant vial, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The reporter consented to follow up.
This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of PEDVAXHIB injection (lot # L009649 with expiration date 29-NOV-2017, lot # K026532 with expiration date 07-AUG-2017 and lot # L030864 with expiration date 07-JUN-2018; doses and route were not provided). There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.