chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received dose #1 of Pfizer vaccine at 12:48 PM.  After about 10-12 min wait period in waiting area, c/o feeling "whoozy", a metallic taste in mouth and tingling of mouth.  A short time later, reports that symptoms are worsening.    Walked with stand by assist of two to cot.    BP elevated, other VSS.    C/o feeling "whoozy", middle tongue feeling swollen, metallic taste in mouth, mouth feeling numb/tingling.  Symptoms progressed to rest of body feeling "tingling".  Denies dizziness. Symptoms progressing.  Denies SOB, itchy throat or throat swelling sensation.  Denies any itching of skin.  No hives or rash noted.  Due to worsening of symptoms, a First Responder was called at 2:01 PM for transport, monitoring and treatment in ED.
Next day 10:00 - 11:00 AM fever, high fatigue, chills, limited urine stream, sore injection site....slept for the rest of the day and to the next morning 9:30AM and now back to normal outside of a few passing chills which stopped end of day. Urine stream gradually came back to normal by end of day as well.
Receiving her second dose past 36 days; sore arm; Loss of mobility (left arm); No range of motion (left arm)/could not use her arm for 4 weeks; Tenderiness; thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) and MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm). On 27-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) (seriousness criterion disability), MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) (seriousness criterion disability) and TENDERNESS (Tenderiness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Receiving her second dose past 36 days) and MYALGIA (sore arm). On 26-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks that the vaccine may have been administered in the wrong area/vaccine administrator may have administered it in the wrong part of her arm) had resolved. On 15-Mar-2021, INJECTED LIMB MOBILITY DECREASED (Loss of mobility (left arm)) and MOBILITY DECREASED (No range of motion (left arm)/could not use her arm for 4 weeks) had resolved. At the time of the report, TENDERNESS (Tenderiness) and MYALGIA (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Receiving her second dose past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.  It was reported that the patient will be receiving the second dose on 27 Jul 2021.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Address, New events were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Today I woke up with a runny nose, light headache, sneezing, right now I am still the same as in the morning, no temperature. On February 27, 2021 I was at the dentist office, other than that noting unusable.
Inconsolable crying for 8 hrs; Hospitalized because parents were concerned refused feeding; Also exp sl swelling rt thigh, t100.1f;
After receiving COVID-19 Moderna vaccine dose 1 on 1/28/2021, came down with headache and soreness in left arm the next day. Throughout the night on Saturday, 1/31/2021 began having stiff neck and left side, including arm and leg, became weak with numbness throughout. The numbness was mostly felt in fingers and toes of left side. These symptoms continued and progressively became worse throughout the following week 1/31/2021-2/8/2021. In addition to the left side symptoms worsening, numbness and weakness developed in the right side fingers and toes. On 2/8/2021 numbness and weakness in left side became so bad that left leg was very heavy and dragging when trying to walk.  I was unable to work that day and was told to call Employee Health.  Employee Health directed me to go to the Emergency Room. While at the Emergency Room, I received lab tests, XRay, EKG, CT Scans, and MRI of neck. MRI was evaluated by Neuro/Orthopedic Surgeon who diagnosed me with Cord Compression Myelopathy and told me that I needed immediate urgent surgery. ER Doctor, Neuro/Orthopedic Surgeon and Hospitalist all felt that the COVID-19 vaccine could have caused the inflammatory immune response that led to further cord compression.  I had anterior cervical discectomy and fusion (ACDF) surgery on 2/11/2021. The hope of the ACDF surgery was to stop further progression of the symptoms of numbness and weakness, but was not guaranteed to restore normal function of the left side. I am currently still experiencing numbness and weakness in left side postoperatively.
Patient reported having swelling, redness, soreness, and hot to touch reaction in her arm. She said this reaction lasted for about a week and it left her mouth, and lips peeling. The patient reported that today (10/14/18) the reaction has completely resolved and she is fine but she will not be getting this vaccine again.
Information has been received from a MA concerning an 81 year old male with no medical history who on 04/19/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). There was no concomitant therapy. The medical assistant reported that in April 2004, the pt developed redness and swelling at the injection site. Unspecified medical attention was sought and on 04/21/04, the pt was given a triamcinolone acetonide (Kenalog) injection as treatment. No lab/diagnostic tests were performed. At the time of this report, the outcome was unknown. The MA also reported that another pt developed redness and swelling at the injection site after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0405USA00169).  Additional information has been requested. Follow-up information inndicated that the patient was doing fine. He was treated with an antibiotic and no further work-up was necessary. He recovered after the treatment. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 11th November 2018, the patient received SHINGRIX (intramuscular). On 12th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in right deltoid and had a 4 inch red area around the injection site. This call was transferred to medical information (MI) for further assistance.
73 year old male with COPD, BPH, HLD, seizures, HTN presented to ER with fatigue, SOB. Recently admitted for leg/hip fracture. His neighbor was apparently covid positive. He started developing sore throat, dry cough, fatigue, SOB, fever. Was found to be COVID + in ER. Admitted to hospital medicine. Completed 5 day remdesivir dose on 10/4. Worked w PT who rec SAR vs home w homecare. Pt prefers DC home w homecare. Pt was feeling well on day of discharge and medically stable for discharge. Pt was present during discharge planning and agreeable to plan.
Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 17-OCT-2013 at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 26-AUG-2016, the patient was treated at the medical center for a painful outbreak that was diagnosed as herpes zoster, or shingles. On or about 04-SEP-2016, the patient was treated again for continued and worsening symptoms of shingles outbreaks. The patient has been prescribed VALTREX for management of his painful symptoms and outbreaks. 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. Additional information has been requested.
Fever, swelling at injection site, irritability, severe eczema breakout as well as hives all over his body.
A FOURTH DOSE OF ROTATEQ WAS GIVEN ON 2/8/07 @ 12:55. FIRST DOSE OF ROTATEQ WAS NOT NOTED OF HIS IZ CARD IN CHART. WHEN THIS WAS DISCOVERED, I CALLED THE CDC TO ASK FOR POSSIBLE SIDE EFFECTS. DR CALLED FAMILY TO NOTIFY. NO KNOWN SIDE EFFECTS REPORTED BY FAMILY. AT TIME OF APPT. T:99.5;CHILD HAD SLIGHT COUGH O2SAT:98%
RED, SWOLLEN, PAIN, ITCHING AT INJECTION SITE, STILL HAVING SAME SYMPTOMS AS OF THIS WRITING
Patient received Pneumovax, and Menactra on right deltoid muscle, and Varivax on righter aspect subcutaneous area on 27May2011. Following day, Pt had swelling on right upper arm, itchiness, redness area and warm to touch, went to ER during weekend. On 31May2011, Patient showed up Immunization. Nurse measured right upper arm red, warm to touch, swelling, length 25cm, width 28cm. temp:98.0F, No itchiness anymore, but "like a muscle soreness when touching" Patient states.  About the "Above Adverse Event Onset Date," since local time is ahead, I put 05/30/2011, but actual onset date is 31May2011.
Wet cough followed next day with highly irregular heart beat. I have some experience with premature ventricular contractions. Generally quite rare and moderate.  This has been incessant all day.
On 02/21/00, this patient was diagnosed with severe idiopathic cardiomyopathy. He had an "URI" approximately 3 weeks prior. (The patient understands idiopathic but believes this can be due to the vaccine). FU indicates onset of cardiomyopathy approximately 2/1/00.
about 28hrs post vax devel 103-104 fever lasted 8 hrs; seen in ER w/nl lab results
Large welt and swelling at injection site 3 x 3 inches, rapid heart rate (tachycardia 100+ bpm)
She got admitted to the hospital for stroke like symptoms. The doctors diagnosed her with Bells Palsy. The doctors told her that the Bells Palsy was probably from the covid vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 34-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 between 9:00-10:00  (Lot Number: EP7534) as single dose for covid-19 immunisation at the age of 34-year-old.  No additional vaccines administered on the same date. There is no medical history of patient and family and no concomitant medications. The patient got admitted to the hospital for stroke like symptoms. The doctors diagnosed her with bells palsy. The doctors told her that the bells palsy was probably from the covid vaccine. The event started on 13Apr2021 with outcome of recovering. The patient went to the emergency room and physician office for the event and was hospitalized for the event from 13Apr2021 to 15Apr2021. Everyone in the hospital did not know if she should get the second dose of the covid vaccine. She sucked it up and got the second dose of the covid vaccine on 17Apr2021(Lot number: ER8737) at about 10:30 in left arm..  No follow-up attempts are needed. No further information is expected.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003209:
Severe allergic reaction and swelling of the hands feet groin scalp/neck & buttocks
It was reported that a female patient received a Fluzone SV vaccination on 11/20/2000. Approximately 24 hours after the vaccination, the patient developed a red area at the injection site.
Vaccine #1 at 9:45am on 3/30/21: Started feeling tired in first 12 hours; next 12 hours nausea, diarrhea, aches, fever 2.5-3 degrees elevated; next nine hours same with increasing intensity along with trouble breathing. Went  to ER at 5:30pm on 3/31/21. Blood oxygen was at 72%. Rapid covid test negative.  Chest X-ray described as ?white cracked glass?; 2nd covid test negative. Admitted as non-covid patient at 11:30pm. On BiPAP machine at 100% oxygen for for two days. In hospital for nine days.
08/23/2023 Mom stated that patients arm was red, warm, hard and swollen.  Approximately 3 inches by 3 inches. On 08/26/2023, the arm started looking better and on 08/27/2023 was basically back to normal.  Mom gave child ibuprofen and did ice packs to area, while the arm was so red and swollen.
46th day between doses; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46th day between doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46th day between doses). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46th day between doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Information has been received from a health professional concerning a 16 week old male who on 29-AUG-2007 received a first oral dose, and on 29-OCT-2007 he received a second oral dose of Rotateq (lot# 656379/0505U. Concomitant vaccination on 29-AUG-2007 included Prevnar, (manufacturer unspecified) DTaP and poliovirus vaccine. It was reported that on 16-OCT-2007 he was taken to the emergency room after he had developed screaming for five hours, had bowel movements two to three times a week, and when there were bowel movements it was several times a day with odor and blood in the stool. On 08-NOV-2007 he developed a hard abdomen,was screaming rhythmly, vomited six times, and was hospitalized. Treatment, diagnostics, and current patient status was not reported. A product quality complaint was not reported. Further information was not available. Upon internal review, it was determined that bowel movements several times a day with blood in the stool was an other medical event. Additional information has been requested. 1/9/08-records received for DOS 11/8-11/9/07-DC DX: Intermittent insussusception, resolved. Reflux.  Had a gasping episode on 11/7/07 at 5:00 a.m., appeared to shake his legs and arms and let out a giant gasp proceeded to a shrill cry. Later vomited 10-11 times over 2 hours. Continued over course of next day to have intermitten high-pitched screams.
About 36 hours after receiving the vaccine, felt extreme tenderness under left arm (pit) and found a lump that felt the size of a golf ball.
noted to be lethargic & limp for <1min w/in 24hr of vax;then was fine p/mom's stimulation;nursed well thereafter;had nl exam later in office;mom was counseled as to when to call back etc;no further tx required;
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 637369/1043L). Subsequently, the patient developed a local reaction at the injection site. Medical attention was sought. At the time of this report the outcome of the event was unknown. Additional information has been requested. Related WAES01111227.
This spontaneous report as received from a consumer refers to her 64 years old husband with diabetes and no Drug Reactions/Allergies. The patient's medical history included stent. The patient was vaccinated SC with a dose of ZOSTAVAX 0.65 ml (Lot number not reported) on 02-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. Consumer reported that on 03-OCT-2012, after getting ZOSTAVAX the patient noticed a red spot larger than a quarter at the reaction site. It did not itch and has started going away as of 04-OCT-2012. No treatment information was reported and no lab diagnostics were performed. At the time, the spot was getting smaller and the patient was recovering. The patient did not seek medical attention. The relatedness for red spot larger than a quarter at the reaction site is unknown for ZOSTAVAX. Additional information is not expected.
sweating/dizziness in 10 mins after shot. Extreme chills/fatigue - next 24 hours. Day 1 after shot silver dollar sized bump-red, painful formed near elbow. Whole arm from injection site down swelled up. Radiating pain off and on from armpit down rib cage. By Monday following, doing better.
Wife called 5:17pm on 10/16/11, husband since mid afternoon had a fever, felt nauseous, pain in arm, rash on arm & body. No SOB. Advised apap or ibu for fever and BENADRYL for rash. Released to primary MD or ER if SOB occurred.
Patient got the injection on Friday 9-7-12 and noticed her arm getting red where the shot was given and by Monday 9-10-12 the whole arm (back of arm) was red, warm, & a little swollen from elbow to arm pit.
Pt tested positive for COVID 9/21/21 s/p fully vaccinated w/ J&J vaccine on 4/7/21. Pt admitted to hospital 10/11/21 with CVA - d/t coagulopathies from COVID.
MILD NAUSEA INITIALLY. ONSET WAS IMMEDIATELY AFTER VACCINATION. OVER THE NEXT 5 HOURS, NAUSEA INTENSIFIED, ALONG WITH WEAKNESS, PALIPITATIONS, BREATHING ISSUES.
he doesn't feel right, kind of numb; within 2 hours it put him in bed, completely exhausted; Headache; Muscle ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:50 (Lot number: ER2613) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "they took his upper right lobes, lungs", start date: 2018 (unspecified if ongoing), notes: Verbatim: they took his upper right lobes, lungs; "COPD" (unspecified if ongoing), notes: Verbatim: COPD. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for chronic obstructive pulmonary disease; INCRUSE taken for chronic obstructive pulmonary disease. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "within 2 hours it put him in bed, completely exhausted"; HEADACHE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Muscle ache"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "he doesn't feel right, kind of numb". Therapeutic measures were taken as a result of headache.  Clinical course: The patient stated that he called about the COVID 19 vaccine. He said that he had the vaccine on 18Mar2021 and of course within 2 hours it put him in bed, completely exhausted. He reported a headache, muscle aches, he said that these side effects were expected but what he did not expect was that he still had the headache. He reported that he was partially recovered by 19Mar2021 because he still had achy muscles for a couple of days and still had the headache. He said that he ended up taking a couple of extra strength Tylenol, that eases it, he took a couple more hours later and it would almost dissipate it but before completely gone it was banging again. He then clarified that completely got rid of it. The muscle aches lasted a couple days. Specific outcome unknown. He said that there were a couple days where he just do not feel right, kind of numb: Date: it was one day of that a week and a half ago, it happened a couple of times up until now-could not really gave an onset date for that. Headache treatment was extra strength Tylenol, 500mg each tablet, he takes 2 initially generally in the morning, 2 in the evening if still having a problem. LOT number SCA040, expiration date Feb2024. UPC: Not provided. AE did not require a visit to Emergency Room, Physician Office. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Family Medical History Relevant to AE(s). No Additional Vaccines Administered on Same Date of the Pfizer Suspect. He said that he was leaning towards not getting the second dose.  No follow-up attempts are possible. No further information is expected.
Approximately 20 hours after vaccination, patient had an extreme dizzy spell at work along with cold sweats and nausea.