chrisvoncsefalvay/vaers-outcomes huggingface dataset:
confused; extremely weak; cold and clammy; barely could move arm; banged head on cabinet; overwhelming nausea; lost consciousness; arm hurt a little bit/throbbing pain; Felt fatigued; A spontaneous report was received from a consumer, who was also a 73-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurt a little bit/throbbing pain, felt fatigued, confused, overwhelming nausea, lost consciousness, banged her head on the cabinet, extremely weak, cold and clammy and barely could move arm .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, the patient received the first of the two planned doses of mRNA-1273 (batch# 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On the night of 13 Feb 20212, the patient experienced arm hurt a little bit and she felt fatigued.  In the early morning of 14 Feb 2021, the patient went to the bathroom.  On her way to the bathroom,  she felt confused and had overwhelming nausea.  She lost consciousness and banged her head on the cabinet.  Within second, she regained consciousness but felt extremely weak.  She could not recall how she got back to her bed.  The patient said she was cold and clammy at that time and she never got back to sleep.  During the day on 14 Feb 2021, the patient felt a throbbing pain on the arm where she got the injection.  She was not sure whether that was due to the injection or due to her fall when she lost consciousness.  She could barely move the arm.  Then she took a nap in the afternoon and was able to recover from her lack of sleep that night.    Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown (although her doctor advised her not to get the second dose given the reaction she had).  The outcome of the events was resolved on 15 Feb 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Additional information has been requested.  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
Low grade fever. Arm pain hurt so bad. Could not move arm. It is now the 25th of September, 16 days after the shot and my arms (both) still are painful to use.
pt had a positive COVID test on 1/10/22 in Assisted Living; was brought to Hospital on 1/20/22 and stayed until 1/27/22 with mental status changes; found to be hypoxic and hypotensive; transferred to ICU with O2 supplementation; DKA; COVID pneumonia; NG tube placed; treated with ABX and steroids; pt improved enough to be dc'd to home where pt passed away
@ 10:38 AM FELT WATERY EYES, NASAL CONGESTION PT USED HIS OWN INHALER AT THIS TIME 2 PUFFS.THEN MOM TOLD ME TO COME SEE HIM. AT THIS TIME THE PATIENT WAS RED RED AND A RASH HAD BEGUN TO COVER HIS BODY  @ 10:43 AM WAS GIVE IM BENADRYL PER DR. GIVEN BY RN. @ 11:15 AM WAS GIVEN 0.4 CC EPPIE BY RN PER DR. @ 11:25 AM WAS GIVEN ALBUTROL BY NEB PER DR. @ 11:30 GIVEN 60 MG OF PREDNISONE BY DR.
Bursitis from immunization (FLUARIX) administered high on the upper arm. Physical therapy and rest as treatments.
Diarrhea shortly after vaccines, called after hours that night. Went to ER on 04/13/18 and was having bloody diarrhea and crying.
Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the shower I became weak, ears started blocking, and started to have tunnel vision. Progressively got worse and was able to sit with head between legs. Took about 1 minute before I didn't feel like I was going to pass out. Shaky and weak after. Pulse 78 and oxygen level ok. Completed virtual visit and no further medical treatment advised unless symptoms got worse, but advised it was likely a vaccine reaction.  Shortly after a bad headache and body aches developed (expected side effects).
Chills and night sweats started at 10pm on 2/18/22 and last a few hours, right arm numbness , pain, tingling , right arm heaviness- started 2/19/22 at 7pm still ongoing
pt recv vax 22MAY96 & 23MAY96 pt exp severe neck stiffness & shoulder pain;
Within 10 minutes of vaccination C10 Right arm tingling/numbness, facial numbness Tx: Vitals monitored Symptoms resolved to received 2nd dose under normal 15 minute monitoring 2nds dose 1/28/2021- no adverse reaction.
Fever for about 24 hours ranging from 99.9 to 100.9 Extreme tiredness
Fever for 24 hours, bilateral arm tingling and numbness, nausea, headache, fatigue, bilateral leg pain.
A couple days after I received my vaccine I had a sinus headache, body aches, and a runny nose. That day I took a COVID-10 test that came back negative.  I did not receive care from a doctor because I felt like it was just a simple cold. I hydrated myself and rested. My symptoms lasted about a week.
Fever 100, swelling, redness and pain to Rt deltoid starting 9/15/15. Mild nausea. Office visit 9/17/2015 - less pain, sl redness.
Anxiety; Depression; Patient was unable to work because of the symptoms; Horrible fever; Chills; Neuropathy; Pins and needles/paresthesia; Not being able to walk; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020f21a and 052e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles/paresthesia), GAIT INABILITY (Not being able to walk), PYREXIA (Horrible fever) and CHILLS (Chills). On an unknown date, the patient experienced ANXIETY (Anxiety), DEPRESSION (Depression) and IMPAIRED WORK ABILITY (Patient was unable to work because of the symptoms). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), ANXIETY (Anxiety), DEPRESSION (Depression), PARAESTHESIA (Pins and needles/paresthesia), GAIT INABILITY (Not being able to walk), IMPAIRED WORK ABILITY (Patient was unable to work because of the symptoms), PYREXIA (Horrible fever) and CHILLS (Chills) had not resolved.            Concomitant product not reported  Treatment medications also included unspecified depression and anxiety medications  Noted discrepancy in Date of Birth (19-AUG-1997) and Age at time of onset of reaction/event - 34  Company comment: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Neuropathy peripheral, Paraesthesia, Gait Inability and the expected events Pyrexia and Chills approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The events Anxiety, Depression and Impaired wor ability occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Neuropathy peripheral, Paraesthesia, Gait Inability and the expected events Pyrexia and Chills approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The events Anxiety, Depression and Impaired wor ability occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
only liquid CYW-135 component was administered; only liquid CYW-135 component was administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA687A, expiry date 31st October 2022) for prophylaxis.   On 14th March 2022, the patient received Menveo. On 14th March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAR-2022, 24-MAR-2022 Reporter's Comment:  The patient received a partial dose of Menveo as the nurse only administered the liquid CYW-135 component. The reporter consented to follow. Additional supportive information:  The patient received only liquid component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case US2022053914 is identified as duplicate of case US2022053915. All future correspondence would be added in case US2022053914, which stands as case of record for this patient and the case US2022053915 would be deleted. This case has been linked to the case US2022053912 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053912:same reporter US-GLAXOSMITHKLINE-US2022053915:same patient, same reporter - FU1 - Deleted
Information has been received from a doctor of pharmacy concerning an approximately 63 year old female with a history of shingles 6 weeks before vaccination (approximately on 06-DEC-2010, who on 17-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number not reported). The doctor of pharmacy reported that on 17-JAN-2011 after the vaccine was given the patient's entire arm from the shoulder down to the elbow became red and swollen. Time frame to start of the swelling after the vaccine was administered was not specified. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
developed shingles, mild case in one dermatome 3-5 days after the vaccine
I didn't really have anything the day of except for a sore arm. Then in December I had a very bad headache, lots of sinus pressure, exhaustion, and very little appetite. I had a slight fever around 100 degrees. The headache, sinus pressure, and fatigue were the worst of it. I also had a cough. It lingered for about 4 weeks. I started to feel better after taking Paxlovid but a few days later I felt the rebound and felt worse than before. In early February, I was still having sinus issues so I went to urgent care and had a number of tests done. They told me that I had what looked to be a sinus infection.
0.3 ML DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 63 year old male. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced 0.3 ml dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 0.3 ml dose of vaccine administered was not reported. This report was non-serious.
irritable & vomiting 2 hrs p/vax administered sz @ 2PM; pt taken to hosp & admitted to ICU x 3 days;
Body felt like "I" was getting over Flu; Easily out of breathe; Nausea and vomiting started wednesday at 6 am; Vomiting started wednesday at 6 am; could not hold down anything.; Body aches; Exhaustion/ body drained and was overexerted easily; Woke up at midnight freezing with chills/shivering and could not warm up; Ran 100 plus fever from then until 7pm Wednesday.; After a few hours after vaccine, had headache; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 04May2021 at 10:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 14:00, the patient experienced headache. On 05May2021 at 00:00, the patient woke up at midnight freezing with chills/shivering, could not warm up, ran 100 plus fever from then until 19:00 Wednesday. On 05May2021 at 06:00, the patient had nausea, vomiting and could not hold down anything. On 05May2021, the patient had body aches and exhaustion. On 06May2021, Thursday, the patient's body felt like getting over flu; body drained, was overexerted easily and out of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 00:00, the patient underwent body temperature test and the result was 100 plus (units unspecified). The clinical outcome of the event ran 100 plus fever was resolved on 05May2021 at 19:00. The clinical outcome of the events headache, woke up at midnight freezing with chills/shivering, could not warm up, nausea, vomiting, could not hold down anything, body aches, exhaustion, body felt like getting over flu; body drained, was overexerted easily and out of breath was resolved on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
ERYTHEMA, LOCALIZED EDEMATOUS AREA AT INJECTION SITE GRADE 3; 75CM WIDE X 111CM LENGTH MEASURED ON 1/13/2021
The next day there was a large, round, red, inflamed area at injection site. It was the size of a tennis ball and warm to the touch.
5-6 hours after injection I woke up due to shortness of breath, mild nausea, and body ache. Shortness of breath was most concerning. Was awake for several hours trying to find a position that helped my breathing. Used Albuterol inhaler, which is extremely rare for me, and that seemed to help. In the AM I was tired from lack of sleep but symptoms had subsided. I don't think there is a longer term issue, but I have never had an adverse vaccine reaction before and wanted to flag it. This is the first time I have received the High Dose Quad version of flu vaccine, which I try to get yearly.
Red spots on torso in various locations and various sizes. Slightly raised but not irritated or itchy. Slightly sensitive and can become irritated after exercise or warm shower. Continuous development of spots, initial spots growing in size. Abnormal and oval shapes.
GREEN PHLEGM; EARS HURTING; PRESSURE/PAIN IN CHEST; SORE THROAT; TINGLING, BOTHERSOME, HURTING NECK GLANDS; HURTING NECK GLANDS; DISCOMFORT; SWELLING OF THE GLANDS IN THE NECK AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included diagnosis of covid-19, and lost smell in one nostril. The patient was previously treated with ibuprofen for lost smell in one nostril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 11:15 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 MAY-2021, the subject experienced discomfort. On MAY-2021, the subject experienced swelling of the glands in the neck area. Treatment medications included: salbutamol sulfate. On 26-MAY-2021, the subject experienced tingling, bothersome, hurting neck glands. On 26-MAY-2021, the subject experienced hurting neck glands. On 27-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced pressure/pain in chest. On 29-MAY-2021, the subject experienced green phlegm. On 29-MAY-2021, the subject experienced ears hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from discomfort, and the outcome of tingling, bothersome, hurting neck glands, sore throat, pressure/pain in chest, green phlegm, ears hurting, hurting neck glands and swelling of the glands in the neck area was not reported. This report was non-serious.
fainting spells ( feeling warm/hot and dizzy) 5 minutes post vaccination no loss of conciousness she was  alert and coherent the whole time.  treatment done  placed on supine position with elevated legs- Felt a lot better few seconds after. Prior to vaccination she verbalized she is scared of shots
The patient reported a history of syncope episodes with injections in the past. He reported that he vomited and passed out with his last four vaccines- flu and pneumonia. This time he was given his vaccine at 9:45 am and was sent to "high risk" observation and was monitored for 30 minutes. He experienced hypotension and tachycardia but did not faint. He was evaluated by the EMS at 10:10 and transported to the ED at 10:39 am. Upon arrival, his systolic BP was 90 mmHg with normal heart rate. He was monitored and discharged home with the final diagnosis of vasovagal syncopal response.
05/01/2003: Telephone call from mother of patient- states patients right arm, red, warm and swollen to elbow.  Seen by PMD on 05/01/2003 and patient started on augmentin/amoxicillin.
Information has been received from a health profesional concerning a 10 year old male who on 09/26/96 was vaccinated with one dose of Varivax. On 02/05/2002, the patient presented to the physician's office with 100 vesicular lesions and low grade fever. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, titers for measles, mumps, and rubella were drawn and serologic testing showed immunity to measles and mumps and equal to rubella. Outcome of the event was unknown. The relatedness for the event was unknown for MMR II. Additional information has been requested.
Caller reporting temperature excursion. Vaccine has been administered.; This spontaneous report has been received from other regarding a patient of unknown age and gender. Patient's pertinent medical history, concomitant medications, drug reactions and allergies were not provided.  On 12-OCT-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliters (lot# X006982 is a valid lot for varicella virus vaccine live (oka/merck) (VARIVAX) , expiration date was reported and stablished upon internal validation to be 07-MAR-2025), administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (product storage error).
Pt complained of numbness/ tingling in the left arm. Vitals signs are taken 110/73 pressure/ Temperature: 98.4 oxygen 100%   and provider checked on Pt explain is a normal reaction she will be fine in hours, o days. Advised to call the clinic if worsening persists.
Moderna COVID-19 Vaccine EUA  Injection site rash and skin discoloration, has lasted for 8 days. Slight itching and warm to the touch.
Patient started with total body itching--flank, feet, hands -everywhere.  When he scratched the areas--he immediately got welts.  Only after taking Allegra did the itching subside.  He saw a PA and then a dermatologist who both agreed he should stay on the Allegra.  When he has tried stopping the Allegra, the itching and welts returned.  He did get the Moderna Booster  Oct. 23rd 2021 .  The Pharmacist told us to report what had happened. He is still taking Allegra.
Tested positive for covid upon routine admission testing for Labor and Delivery at our hospital per department policy. Patient is asymptomatic for COVID.
Patient developed a marble-sized lump under his skin in the injection location. This lump has persisted to date, over a year.
PATIENT EXPERIENCED SWOLLEN EYE AND RASH/HIVES ON BODY. NO TROUBLE BREATHING.
The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had Juvederm lip injections for almost 2 years but had recently gotten a touch up on only my top lip last November of 2020. Bottom lip is fine. Consulted with my doctor. Took Benadryl and was prescribed Claritin and steroids.
Vaccine given at 1457 hrs. Fifteen minutes later patient started feeling L arm became numb down to fingertips, face flushed & hot, BP 140/80 pulse 88 Temp 96.4.  Seen by Dr.  Benadryl 50 mg po given at 1525 hrs. 1548 hrs patient feeling better, flushing cleared arm numbness improving.
Left arm sore, feeling run down, running nose, congestion, headache, fever, chills, fatigue. Called nurse 7/24/17. Did not seek other tx.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    Concomitant medications were not reported.   Patient received full dose.They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions.  Treatment medications were not reported.
Chills, nausea, fatigue, right side chest pain, hard to breathe, excessive seizure like shaking.