chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness in BLE, shallow breathing, elevated B/P (systolic ranging from 213 to 163), this morning B/P 179/89 Went to ER, script from hospital were just painkillers per husband. Recommended to continue taking b/p medications, and to obtain a pulse oximeter, and oxygen tank depending on blood oxygen reading. If symptoms worsen, contact primary provider. 4/19-Completed follow up call on 4/19/2021 at 10:27am: Pt reports that she feels a little weak (she contribute this to her laying down too much), and feeling lightheaded when she stands up to quickly. Otherwise, pt reports she is feeling much better today (BP 149/71, pulse: 79, blood sugar: 78). Pt states she went to the ER as a percauation, tests were done and she was released the same day she went in. Pt reports she is to follow up with her MD,  and no prescriptions was written from ER. Pt also reported that with both of her shots she had some tenderness in her right arm ~1 hour afterwards, the tenderness went away the next day. Recommend pt to regularly monitor her BP and blood sugar at home, keep a log and bring to her follow up visits with MD. Also recommend pt to make sure to get up slowly from sitting or laying down position, and to hold onto something while standing for approx. 30 sec to a minute to make sure stance is steady enough walk to prevent fall risks since she states she gets lightheaded.
On May 13th my right arm (where I got the shot) was in extreme pain as of this report it hasn't gotten much better..
Pt developed a maculopapular rash & fever 9 days after administration of the MMR vaccine.
Tested positive for COVID-19 after first dose; Sore throat; Headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test positive: (Positive) COVID-antigen PCR-Positive.     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.   Treatment medication include Acetaminophen. No concomitant medications were provided by reporter.
12/17/2020 Woke up at about 7am, pain at injection  site, swelling.  At end of day, started to have extreme HA and joint pain. Tried to sleep as much as possible. But 12/18/2020 felt even worse.  Was unable to report to work. Mgr recommended the rapid test for Covid on 12/18/2020.  *drive up test.  Didn't want to take tylenol to mask fever. Rested friday and sat. Felt better 12/19/2020. Symptoms were mild to moderate.  Temp highest was 37.9  12/20/2020 'still feel warm', body aches, joint pain, headache are 'still there' but 'more tolerable'.
The patient called to report local redness , swelling, and pain at the site of injection in the left shoulder.  The patient also mentioned some itching sensation.  No other symptoms mentioned.  Recommended cold compress, benadryl, ibuprofen.
Shot given 4PM; itching around inject site by 6PM; pt reports redness around inject site & swelling fromshoulder to elbow w/egg size nodule under arm; Seen by MD on 23OCT91; given DPH & Keflex;
Rotator cuff tenditnitis - Injected limb mobility decreased. Shoulder pain. Initial report received on 31 October 2008 from a healthcare professional in the United States. A 43 year old female, with a history of rheumatoid arthritis and unknown concomitant medications, received on 08 October 2008 a left deltoid intramuscular injection of FLUZONE (lot number U2832AA). She had no illness at the time of vaccination and had received no other vaccines in the previous four weeks. At the time of vaccination, the patient complained of pain. She continued to have a dull aching pain and one week later she began having difficulty abducting the left arm. At the time of the report, the symptoms were persisting. Follow-up information received from a health care professional on 21 November 2008. The patient had experienced immediate discomfort after the FLUZONE vaccination. Site of pain was confirmed to be the left shoulder with no radiation of pain. The patient continued to have constant left shoulder ache, pain with movements and limited range of motion in forward flexion due to pain. diagnosis was left rotator cuff tendinitis. Treatment included FLECTOR PATCH and six visits to physical therapy. As of 14 November 2008, the patient's condition showed improvement. Follow up information was received on 22 December 2008 from a health care professional in the USA. The patient had a history of hypothyroidism and gastroesophageal disease in addition to rheumatoid arthritis. The start date of the left rotator cuff tendonitis and pain were on 08 October 2008. The patient was medically evaluated on 04 November 2008. As of 15 December 2008 she was 90% improved. She completed six visits of physical therapy. She would occassionally use a LIDODERM PATCH and over the counter TYLENOL.  No further physician visits were needed. Documents held by sender: None.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-OCT-2011, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician/MD for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, Severe varicella pneumonia was determined to be a medically significant event. Additional information has been requested.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 3-Aug-2022 Reporter comment: The nurse reported that the patient was administered a dose of Bexsero on 02th Aug 2022 , which had an expiration date of 31th Jul 2022.   This was the patient's second dose in the series.  At the time of reporting, the dose has not been repeated. Did not consent to follow-up. Additional supportive Information: The patient received vaccine which was already expired which lead to expired vaccine used.
The Monovalent COVID-19 vaccine was inadvertently given to the patient who was scheduled to receive the Bivalent COVID-19 vaccination as per the recent FDA approval of the Bivalent COVID-19 vaccines. The patient was notified of the error on the same day of the incident and written communication is being drafted and sent to all patients reiterating what was discussed over the phone with the patient. Further action is underway with the guidance of the CDC Interim Clinical Considerations for using COVID-19 Vaccines. All patients were instructed to follow up with their primary care physician and were offered the opportunity to receive a booster dosage in line with the recommendations of the FDA.
This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: highly susceptable to nausea, and highly susceptable to motion sickness. The patient experienced drug allergy when treated with sumatriptan. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) first dose dose was not reported, 1 total, administered on 08-APR-2021 on left arm for covid-19 prophylaxis. On an unspecified date, the patient experienced covid-19 infection (dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (Pfizer) (dose number in series 2) (form of admin and route of admin was not reported, batch number: FE3690, and expiry: UNKNOWN) second dose, dose was not reported, administered on 30-OCT-2021 on left arm for covid-19 prophylaxis. Concomitant medications included desvenlafaxine succinate monohydrate, and gabapentin. The patient received non-company suspect drug included paxlovid (form of admin and route of admin, batch number, and expiry were not reported) dose was not reported, administered from 03-JUL-2022 for the treatment of covid 19 (coronavirus disease). On 03-JUL-2022, the patient experienced nausea, and vomiting (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and for paxlovid was treatment discontinued on 04-JUL-2022. The patient was recovering from nausea, and vomiting, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
PATIENT HAD COVID VACCINE ON 03/26/21 FOR A FEW DAYS AFTER VACCINE PATIENT HAD FEVER CHILLS. PATIENT ALSO REPORED REDNESS AND SWELLING TO INJECTION SITE. ON 04/01/21 PATIENT WOKE UP WITH A ITCHY RASH FROM HEAD TO TOE THAT PROGRESSIVELY BECAME WORSE DURING THE DAY.  PATIENT WAS SEEN AT URGENT CARE BY APRN. PATIENT WAS INSTRUCTED TO TAKE BENADRYLY 2-3 TIMES A DAY A FOR 2-3 DAYS AND IF NO IMPROVEMENT NOTED TO RETURN TO URGENT CARE. PATIENT REPORTED HAVING RASH FOR SEVERAL DAYS WITH IMPROVEMENT NOTED WITH BENADRYL.
High fever of 104 degrees for 3-4 days, small red bumps throughout body and face. Red bumps also developed at injection site at this time.
Left shoulder intense pain on moving arm in any direction. Limited range of motion. Unable to sleep through night. Unable to use arm full range.
pt recv vax 7OCT97 bilat deltoid rt arm swollen red & hot to touch, inc temp, neck glands ax flank pain (all glands swollen @ 1030PM 7OCT97 went to hosp Er because of pain;
left upper arm pain; persistent itching in that arm; couldn't raise my arm above my shoulder; felt very weak; wanted to lay down all the time.; arm was sore that day at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak) and FATIGUE (wanted to lay down all the time.) in a 44-year-old female 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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore that day at the injection site). On 18-Apr-2021, the patient experienced PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak) and FATIGUE (wanted to lay down all the time.). At the time of the report, PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak), FATIGUE (wanted to lay down all the time.) and VACCINATION SITE PAIN (arm was sore that day at the injection site) outcome was unknown.            No Treatment was received by the patient.   No Concomitant medication was received by the patient   This case was linked to MOD-2021-265825, MOD-2021-265816 (Patient Link).
RN administered hepatitis A intranasal when should have been given intra-muscular.  The patient was to receive a FluMist vaccine that is given intra-nasal.  Patient states that her nose is sore but is not having any other problems.
trembling in my chest area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: ENG201) at the age of 75 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Percodan, reaction(s): "known allergies: Opiods (percodan,etc)"; Aspirin, reaction(s): "known allergies: aspirin". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: e11283, Location of injection: Arm Right), administration date: 21Jan2021, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 14Feb2021, outcome "recovered with sequelae", described as "trembling in my chest area". The event "trembling in my chest area" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor.  Additional information: Three days after, trembling in her chest area that didn't go away. Went to the doctor at the time Dr. [Name withheld], who did an EKG that was normal. He could "feel" the tremor. He said he contacted Pfizer and if it didn't go away in 3 weeks, she should come back to him. She still have it from time to time but have moved to another State. He told her not to get any more vaccinations. Her current doctor agrees. No other vaccine in four weeks. No other medication in two weeks. No covid Prior vaccination. No covid tested post vaccination.
Mom states child's L/leg swollen w/knot, 1/15. Started w/redness about 2" around thigh. Gave Tylenol. No fever, sob, just hot to touch & red. By 1/16, still swollen, increasing to 4" around. Used no ice just cortizone cream.
Adolescent/Adult presentation for ages 12+ years was administered to a 10 year old patient.  Dose was incorrect for age.
First dose 2018. Has not received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose 0.5 ml, in February 2018 ).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). 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 case was reported by patient herself The age at vaccination was not reported. The patient stated that she received her first dose of Shingrix in February of 2018. She had not received the second dose till the time of reporting, till the time of reporting which led to incomplete course of vaccination.  The reporter did not consent to follow-up.
chills; Severe; Soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 30Mar2021 at 09:00 (at the age of 43-years) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) taken from unknown date and for unknown indication. The patient had no allergies to medications, food, or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 11Mar2021 at 09:00 (at the age of 43-years). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced soreness at the injection site and on 31Mar2021, at 02:00 the patient experienced chills and severe fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events soreness at the injection site, chills and fatigue was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
Late in the day of the vaccine, 10/12/17, my left arm hurt as expected from my previous experiences. Pain subsided only slightly the next day but then began to get worse. On 10/16/17 and following, definitely could not lift my arm more than 50% and with moderate to severe pain. I decided to give it time to see if it would go away but as of 11/6, the pain is getting worse and decided to seek medical attention.
A week after vaccination, I felt pain in my right forearm while at work in the morning from around 9:00-11:00 a.m.  Around noon I had realized that the pain had stopped and when I rubbed my right forearm, I realized there was no feeling in my forearm.  I did not immediately go to the urgent care, as I did not want to over react.  I tried to make myself feel pain, to include pinching with my nails as hard as I could with my left hand and and also scratching, thus triggering my dermatographia.  This numbness lasted until about 2:00 p.m. and I had read online that Guillain-Barre Syndrome had been associated with the Janssen vaccine and I left and went to a medical provider to be seen, even though feeling had returned in my arm.
12 hrs p/pts first dose of vax devel severe wheezing; was hospitalized for 3 days + required aggressive resp therapy, oxygen, IV fluids, & IV steroids; @ this time, no correlation to the Hep b vax was made;
Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine; Horrendous cough; Went to ER with high fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine), COUGH (Horrendous cough) and PYREXIA (Went to ER with high fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Obesity and Pancreatitis. Concurrent medical conditions included Diabetes.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine), COUGH (Horrendous cough) and PYREXIA (Went to ER with high fever). On 07-Sep-2021, COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine) and COUGH (Horrendous cough) had resolved. At the time of the report, PYREXIA (Went to ER with high fever) had resolved.            It was reported that the patient had Hormone Replacement Therapy , also Concomitant medications include chronic hormones, as patient is transgender. on 27-Aug-2021 the patient received monoclonal antibody treatment.   This case was linked to MOD-2021-311283 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Followup document contain no new information.
lt upper arm swollen, erythematous, tender to touch;tx elevation, warm packs, APAP for discomfort; sx resolved p/48hr;
Patient received the injection approximately 1:27PM on Friday, February 26, 2021.  She felt fine until about 8PM Friday, Feb 26. At that time, she had feeling of malaise but did not check for fever.   She went to bed and fell asleep. Upon arising on Saturday, February 27, 2021, she felt feverish and had a backache.  Her fever was first checked about 11:30AM by her son and it was 101 degrees.  During the afternoon, about 3PM, she ran a higher fever (102 degrees).  The family consulted her primary care physician, who advised hydration and a Tylenol.  After talking with the physician, about 4pm,  the family gave her a 500 mg Tylenol, which brought the fever down to just under 100 degrees by 8pm Saturday night.  She also had aching legs at that time. but no longer had a backache. She slept Saturday night and awakened on Sunday, Feb 28, with a fever of 99 degrees.  Around Noon another Tylenol 500 mg tablet was administered.   During Sunday afternoon, the fever dropped to around 98.2 (Patient has a normal temperature of 97.3 or 97.4, well documented).   On Monday, March 1, 2021, at 11:00am, her temperature was normal, 97.4.  She said she still felt tired and her legs "don't feel quite right".  However, our family feels she is doing much better and she has enough energy to do some of her normal activities and participate in conversation.
Donor received injection on 07/02/17 and two days following, on 07/04/17, a red, raised rash developed. Area is warm to touch, tender, and measures 4.0 x 4.0 in.
(translation) high temperature 101.4, not hungry, sleeping more than usual, pale, nausea, excessive sweaty hands was taken to the pediatrician and was recommended to be evaluated by neurologist. At the moment of the interview he looks alert, looks well-neurologically speaking, with good color evaluation was made by Dr.
Pt c/o Rt arm started hurting later that evening. The pain radiates from Rt shoulder down to hand. Pain is intermittent. No redness or swelling at site or arm was noted by pt and family members. Pain intermittent x 1 week. Spoke to pt several times during week but did not mention during those times.