chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cannot walk and cannot move due to the pain.; I cannot move my hip; pain is on the left hip and goes down to / left knee; severe nerve pain; I must have been sleeping wrong / has not slept; This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of neuralgia (1st dose received on an unknown date, refer case US2021AMR062577).   On 5th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced unable to walk, mobility decreased, pain in hip, nerve pain and insomnia. The patient was treated with gabapentin. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the unable to walk, mobility decreased, pain in hip, nerve pain and insomnia were unknown.   The reporter considered the unable to walk, mobility decreased, pain in hip, nerve pain and insomnia to be possibly related to Shingrix.   Additional details were provided as follows: The case was reporter by patient's husband. The reporter wanted to know the adverse reactions of Shingrix vaccine due to her wife dealing with severe reaction with second shot. The patient was vaccinated probably last Friday from the date of reporting. The patient was experiencing severe nerve pain.  Either Monday or Sunday that the patient commented, she must have been sleeping wrong.  The patient cannot move her hip, pain was on the left hip and goes down to left knee.  The patient cannot walk and cannot move due to the pain.  The reporter does not know if the pain started on the same day of the 2nd Shingrix vaccine but did clarify that the pain started on 2nd March 2021. The patient and her husband visited healthcare provider to find out what was causing this pain.  The only thing they could think about was the second those of Shingrix vaccine.  The patient was prescribed nerve medicine that was Gabapentin on Monday from the day of reporting, which started calming the nerve down but started flaring up again.  The patient had not slept in three days and wanted to figure something out.  The patient does not want to wait a week. The reporter gave consent for healthcare provider follow up.
CELLULITIS; HIGH BLOOD PRESSURE; ABSCESS IN ARM; HEADACHE; SEPSIS; PAIN; REDNESS IN ARM; FEVER; This spontaneous report received from a 49 year old patient of unspecified sex and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included seizure disorder but had not experienced since 1998. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-MAY-2021 13:00 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the patient experienced redness in arm and fever. On 06-MAY-2021, the patient experienced pain. Laboratory data included: Pain scale (NR: not provided) Level 8-10. On 07-MAY-2021, the patient experienced sepsis, headache, abscess in arm. On the same date, the patient reported initially low fever and later high fever, body temperature was (NR: not provided) 101.9 (unit not reported). On unspecified date MAY-2021 the patient went to emergency room for fever. Patient went to physician where took blood work .On 10-MAY-2021, patient's White blood cell count was high 18.53 (unit not reported) and the patient experienced cellulitis, was treated with liquid Augmentin and blood pressure was high 159/108 (unit not reported), Heart rate was high 147 (unit not reported). On an unspecified date in MAY-2021, second attempt White blood cell count was high 14.63. diagnosed as sepsis and treated with dose of antibiotic unasyn. Currently on unspecified date in MAY-2021 patient had fever of 101.4 (unit not reported). Patient had to be cautious of fevers due to a seizure disorder. On 12-MAY-2021 patient went to ortho surgeon and went back to hospital to treat arm abscess drained.100 cc was removed and still draining puss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, pain, redness in arm, cellulitis, high blood pressure, headache, sepsis and abscess This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521005-covid-19 vaccine ad26.cov2.s-Sepsis, cellulitis and abscess in arm. 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).
HOURS AFTER MY FIRST MODERNA COVID VACCINE, I DEVELOPED A SEVERE HEADACHE THAT MEDICINE WOULDN'T TOUCH.  I TOOK EXCEDRIN MIGRAINE.  FOR TWO DAYS I WAS BARELY ABLE TO LIFT MY HEAD FROM MY PILLOW.  WHEN I WAS ABLE TO GET UP AND WALK AROUND, I WAS VERY SLOW AND SLUGGISH.  tHE DAY AFTER MY 1ST VACCINE, I felt very very bad but the second day after (the 28th of March), it was a bit better.  For about a week after my vaccine, I would have what felt like a literal butterfly inside of my heart.  This was occasional and best I can remember happened when going from lying or seating to standing position.  The final problem I had was that my elbow hurt pretty bad for nearly a month.  It felt like severe tennis elbow.  Yes, this was in the arm where I had the injection.
Sudden hearing loss, left ear.  10/3/2020, 10/3/2020: Treated as blocked eustachian tube, alergy.  10/6/2020-11/11/2020: Oral predisone and five trans-tympanic dexamethasone injections. Still have severe tinitus, severe hearing loss, and only 64% clarity.
Red irritated, raised itchy and rashy (raised bumps)  about a 3X2 spot arm is very sore.
Narrative:  Syncope a few minutes after receiving COVID vaccine  number 1. Went to ER, received 1 L IVF and APAP 1g. Sent home 3  hours later
Pain at injection site. Loss of function of shoulder. Patient claims that injection caused permanent damage to shoulder joint.
Client received Moderna dose 1 on 3/17/21 everything went well. Dose 2 on 4/14 client developed a rash all over body 24 hrs after vaccine. Client denies having SOB, no other symptoms, only itching. Client took Benadryl and subsided after 3 days. Client didn?t go to ER or informed her primary care provider. Client has allergy to shellfish (anaphylaxis). Client has no medical conditions. A medical consult was submitted by RN to Clinical Project Coordinator. Client received approval to receive Moderna Booster COVID vaccine by MD. Client received Moderna Booster Lot#084J21A.  Client reported no symptoms while waiting in observation area for 30 mins. Client left vaccination area in steady gait.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L008660, expiration date 10-NOV-2016) and of an improperly stored dose of ROTATEQ (lot # and expiration date not reported). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA00142, 1509USA001921 and 1509USA001923). Additional information is not expected.
Red, swollen area around injection site. Has become progressively larger since day of injection, as of evening of 12/23 was 5 inches in length. Darker red in middle of circle, lighter red on outside of. Pain is superficial, not deep. No fever. No numb/tingle. Warm to touch. Talked to RN on afternoon of 12/23, as of 12/24 10:55, no return phone call from office.
extreme itchiness all over my body all the time; This is a spontaneous report from a contactable consumer. This 18-year-old female consumer (Patient) reported for herself. An 18-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 21Apr2021 at 12:45 hours as DOSE 2, SINGLE (at the age of 18-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 31Mar2021 at 14:15 hours as DOSE 1, SINGLE (at the age of 18-years-old) for COVID-19 immunization and experienced mild itchiness on back. The patient had no known allergies. The patient had no COVID prior vaccination. The patient was COVID tested post vaccination. The patient took no other vaccine in four weeks. On 22Apr2021, the patient experienced extreme itchiness all over body all the time. The patient would itch so bad that it would draw blood. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and the patient was treated with hydroxyzine 10mg three times a day. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 26Apr2021, Nasal Swab, Antigen testing. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
mom states pt started crying alot & temp up to 101-102 R @ day care; areas of inject are red-not unusually swollen; cry not shrill or unusual; will cont APAP & apply cold, wet compress to inject sites;
Swelling of face; Swelling of walls and bridge of nose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of face) and SWELLING (Swelling of walls and bridge of nose) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced SWELLING FACE (Swelling of face) and SWELLING (Swelling of walls and bridge of nose). At the time of the report, SWELLING FACE (Swelling of face) and SWELLING (Swelling of walls and bridge of nose) outcome was unknown.            No concomitant products were provided.No treatment medication was reported.
Vaccine administered 6/21 about 15:30. By 22:00, pt experiencing headache (5 out of 5 on pain scale) muscle and joint aches. Fevers & chills. Documented temp 103 at home. Vomit x one. Neck pain. All symptoms resolved by 6/22/11 at 16:00.
pt brought to ED with extreme weakness; obtunded; found to be positive for COVID; admitted; given Decadron, Remdesivir, ABX, O2 supplementation; AKI; found to have hepatocellular carcinoma and Hepatitis C; respiratory status worsened; transferred to ICU; Pt had a PEA arrest requiring cardiac resuscitation/intubation with mechanical ventilation; pt's condition worsened; developed pulmonary infarct hemothorax and empyema; thoracotomy and decortication; family made pt a DNR; condition deteriorated and pt passed away in the hospital
4/10 Vaccination. Within 4 hours I had body aches, fatigue, chills.  4/11 Migraine upon waking up. I took Excedrin. I had been out of my migraine medications. Rested all day. Pattern continued.  4/13 My BP had increased (200/140), racing heart, not well. I went to urgent care. They gave me migraine cocktail. I was having all over global pain and concentrated pain. Lidocaine Q-tips in nostrils as a nerve block to help with pain. The rest of the night I was ok but the next day the migraine was back. The medication was for onset of migraine but it was already there and didn't work.  4/13-4/18 migraine persisted 4/18 contacted PCM. They told me they needed to see me. I was having high BP due to the increased pain per dr. They did the same migraine treatment that day. The BP medication stayed same as they felt it was a migraine issue. They prescribed oxycodone that day. They couldn't give Toradol because I had had within 24 hours. I went home, slept and didn't work for 2 weeks.  4/18,4/21 I went to ER. Repeat of treatments for migraine. Was never fully gone when discharged.  The migraine was always there, the night of the 20th I was throwing up, 21st my eyes were twitching and shaking which was new symptoms to my migraine.  *This has triggered my history of migraines to flare up again since giving birth to my daughter 4 years ago.
Moderna COVID-19 Vaccine After receiving Moderna Vaccine Tuesday afternoon (01/05/2021), Patient began to have psychiatric symptoms (delusions/hallucinations) Wednesday morning (01/06/2021) and was taken to Hospital ED later Wednesday for treatment and stayed overnight for observation. Patient recovered and went home Thursday (01/07/2021).
Swollen arm - 48 hours to resolve. Headache - gone with in 26 hours. Cough - 48 hours to resolve. Tired - 48 hours to resolve. No prior adverse effects to vaccine.
Tingling/numbness in fingertips and toes; ongoing since late July/early August 2021. I was advised to drink electrolyte-based liquids in case I was dehydrated, but the drinks had no apparent effect.
blood clot in her lungs; shortness of breath; chest pain; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation.  Medical history included obesity and inactivity. The patient's concomitant medications were not reported. On an unspecified date, patient experienced blood clot in her lungs and was hospitalized on 14Mar2021. Patient also experienced shortness of breath and chest pain on an unspecified date. She was treated with anticoagulant therapy for the event "blood clot in her lungs". Outcome of event "blood clot in her lungs" recovered on an unspecified date while for all other events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
This is a spontaneous report from a contactable consumer (Patient). This 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 (at the age of 73-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Mar2021 (a day before reporting), the patient came down with a cold, with the symptoms of sore throat, runny nose. Her doctor told her if it was not COVID-19, then she was ok to get the second dose tomorrow. Patient who was due for her second dose on 03Mar2021 (a day after reporting), wanted to know if it was Ok to get her second COVID-19 shot if she had cold. However, patient reported that she won't be able to get her second shot because of colds. She planned on mentioning it to the vaccination provider. Patient was Ok with further follow-up from Safety. Patient asked how long the second dose can be delayed. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
HPV on 10/16/2007, 12/26/2007, and 04/30/2008.  Patient diagnosed with inflammatory arthritis.  Symptoms started after receiving the first HPV.
pt recv vax 25MAR96 & 29MAR96 pt exp a sore arm, burning numbness & tingling of lt had & wrist;MD indicated that vax had exp inflammation & secondary nerve irritation d/t the vaccine;pt does not have full strength of lt hand;
Additional information received on 6/23/03 from the reporting physician provided patient demographics, vaccination information, medication, concurrent illness at the time of vaccination, and recovery status. A physician reported that a 4 year old male received his first dose of Prevnar on 11/6/00, at the age of 25 months. Medical history included a cerebrospinal fluid leak/shunt. Concurrent medical history included convulsions. Concomitant medication included phenobarbital. On 1/26/03, the child was hospitalized. A cerebrospinal fluid culture revealed Streptococcus pneumoniae, serotype 23F. An anti-pneumococcal antibody test was low for serotype 23F at 2.63. A diagnosis of pneumococcal meningitis was made. On 2/28/03, he was discharged from the hospital. He recovered.
Received Covid-19 vaccine on March 18 following a temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion). On 18-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact  No concomitant medications were reported. No treatment related information has been reported.
Creatinine levels spiked immediately after (blood tests on 2/18 and 3/01. Portal vein thrombosis was immediately diagnosed in ER on 4/20/2021. Celiac artery stenosis was diagnosed on 4/25/2021. Patient passed away 09/06/2021.
Left arm red, swollen, hot to touch and tender. Patient was seen after hours 48 hours after vaccines, started SEPTRA. On 4/16/18 was seen by Primary Care Provider. SEPTRA was discontinued and Prednisone 20 mg for 5 days was given.
6/12/03 at 8:30 PM Tonic/clonic seizure lasting about 2-3 minutes. In ER, MD prescribed antibiotic for URI.
Moderna COVID- 19 Vaccine: During observation period after receiving the vaccination patient reported headache, nausea, and dizziness. Vital signs: blood pressure: 111/73 mmHg, pulse: 56 beats per minute, oxygen saturation 100%. Patient reports that she is typically hypotensive and does become nauseous somewhat frequently. Patient offered water and snacks.  No loss of consciousness or respiratory symptoms reported. Patient observed for at least 30 minutes and left vaccine clinic in stable condition.
Lightheaded; BP 131/80; HR 88; Patient stable and released from vaccination site
I woke up with a scratchy sore throat, a slight cough and headache. Towards the evening time I started to have the chills, low grade fever of 100, unable to take a deep breath, body aches, and nasal congestion. My cough, and headache got worse that night. The next day I took an at home Covid-19 test on 5/19/22 that came back positive. I had a telephone appointment with my Doctor on that same day, and was prescribed Paxlovid. I currently still have the same symptoms.
1-2 wk p/recvd vax mom noticed episode of head shaking; taken to ER who referred to neurologist; exam by neurologist nl w/no EEG;
Cellulitis below and behind injection site. Visited MD on 10/21/16 and treated for cellulitis. Prednisone 10 y BID and Doxycycline 100 y BIDx5.
body aches; arm pain; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced general body pain and pain in arm. On an unknown date, the outcome of the general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. Age at vaccination was not reported. The patient received first dose of Shingrix on 15th November 2021 and experienced arm pain and body aches which were later recovered. The patient later received second dose on 31st December 2021 within 46 days interval and experienced same symptoms and they were also later recovered on 3rd January 2022. The reporter wanted to know about efficacy when taken early. The reporter was requested to consent for follow up. This case is linked to US2022002058 and for tolerance of 2nd dose refer case US2022002058.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002058:same reporter
no side effects No further AE.; Pediatric dose given to adult.  VAQTA dosed 0.5ml  RECOMBIVAX 0.5ml  7/3/2023; This spontaneous report was received from a medical assistant referring to a 34-year-old male patient. The patient's medical history, historical drugs, concurrent conditions, past drug allergies or reactions, and concomitant drugs were not provided.   On 03-JUL-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (strength was reported as 25/0.5; 0.5 ml, one time; route of administration, lot #, and expiration date were not reported) and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (strength: 10/0.1 mcg/ ml, 0.5 ml, one time; route of administration, lot #, and expiration date were not reported) both for prophylaxis. The dose administered was pediatric dose (incorrect dose administered). No side effects or further adverse events (AE) (no adverse event).