chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it took it's toll on her left hand, which doesn't work as well anymore; The grasping & strength in her left hand are not as good; arm is difficulty to move; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (it took it's toll on her left hand, which doesn't work as well anymore), MOTOR DYSFUNCTION (The grasping & strength in her left hand are not as good), HYPOKINESIA (arm is difficulty to move) and MYALGIA (arm sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis. Concurrent medical conditions included Penicillin allergy. Concomitant products included PICOLAMINE SALICYLATE (REFLEX [PICOLAMINE SALICYLATE]) for Chronic UTI, LEVOTHYROXINE for Hypothyroidism, BOTULINUM TOXIN TYPE A (BOTOX) for Spastic bladder, NALTREXONE and GABAPENTIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (it took it's toll on her left hand, which doesn't work as well anymore), MOTOR DYSFUNCTION (The grasping & strength in her left hand are not as good), HYPOKINESIA (arm is difficulty to move) and MYALGIA (arm sore). On 17-Aug-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (it took it's toll on her left hand, which doesn't work as well anymore), MOTOR DYSFUNCTION (The grasping & strength in her left hand are not as good) and MYALGIA (arm sore) had resolved and HYPOKINESIA (arm is difficulty to move) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided by the reporter. The patient has severe MS and was in the wheelchair for years and was not sure whether the events caused by vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: follow up received on 10-sep-21 with New events, outcome concomitant medications was added.
HEADACHE LASTD 2 DAYS. ONE WEEK LATER INJECTION SITE BECAME SWOLLEN, RED, ITCHY THAT LASTED 2 DAYS Narrative:
Patient received J&J vaccine on 4/12/21. COVID positive on 1/28/22.  Presented to ER on 1/28/22 due to being unresponsive. Glucose was 1175, WBC 33.3, temp of 86.9 F.  Fluids, pressors and antibiotics were started. DKA was treated. Septic shock secondary from COVID PNA or diabetic foot ulcer. Did not receive remdesivir due to kidney function. Received vanc and zosyn. He was intubated and extubated later successfully. Discharged on 3/28/22. Prolonged stay mostly due to foot infection, not COVID
Patient reported feeling tired or general ill-feeling for about 2 days after receiving the vaccination. About 3 to 4 days after vaccination, patient reported a blister on the inside of her bottom lip, and resolved after about 6 days. She also reported a thumb-sized itchy red spot on her right hip, that also occurred about 3 to 4 days after vaccination, and it resolved after about 6 days.
This case was reported by a healthcare professional and described the occurrence of sore (nos) in a 55-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to DURAGESIC, codeine allergy and sulfa allergy. Concurrent medications included Lisinopril, Furosemide, Potassium, Pravastatin and Estradiol vaginal cream. On 9 May 2013 at 10:30 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm); Lot number was reported as 432TJ. On 10 May 2013, 1 day after vaccination with BOOSTRIX, the subject experienced "feeling a little sore". On 11 May 2013 the subject had nausea and a temperature of 102 degrees. On 12 May 2013, the subject was feeling sore and clammy. On 13 May 2013, her left arm started to get red. On 14 May 2013 her left arm had become swollen and painful. it was warm to the touch, and she had decreased range of motion. The subject was started on a five day course of Cephalexin 500 mg on the night of 14 May 2013. On the morning of 15 May 2013, after one dose of Cephalexin, the subject was seen at the office. Her reaction, described as red, warm and significantly swollen had expanded to nearly the top of the shoulder and was 22x18 centimeters in size. Compared to the previous day, it had already started clearing at this point. The reporting healthcare professional found it strange that the location of the actual shot was where it began clearing first, described as a big band of red around the shot area. On 16 May 2013, the healthcare professional had not yet spoken to the subject but described the reaction as improving based on the subject's last visit. At the time of reporting the sore (nos), nausea, increased temperature, clamminess, arm swollen, arm pain, warm to touch, decreased range of motion, injection site pain, injection site redness, injection site warmth, extensive swelling of vaccinated limb and red around injection site were improved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.
This case involves a female patient who experienced headache, chills and flu symptoms (Influenza) after receiving INFLUENZA VACCINE. The patient past vaccination(s) included INFLUENZA VACCINE. Additional medication was reported sulfate allergy. The patient past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious headache, chills, flu symptoms (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Influenza vaccine and sister case (as patient is not sure so the case splitting was not requested). It was reported "The caller declined to provide other demographics. The caller wanted to know what inactive ingredients are in Fluzone Quad and if we can explain why the eggs are soaking in formaldehyde. She reports a history of adverse reaction to flu vaccine in the past, as well as her sister having similar reaction last year and this year with the double vaccine". Details of laboratory data not reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the reported events. There will be no information available on the batch number for this case.
a few pt devel erythema, swelling & dx as suspected cellulitis following inj;caller had no other addtl info to report;
pt started to feel flushed and red, itchy, it subsided ten minutes after zyrtec administration
saw stars;metallic taste;joint pain;low back pain;very pale;nausea;pt felt like was going to die;
The patient had a lot of aching all over the body; Did not slept well; Had a bit of fever; Fatigue/feeling very tired; This spontaneous case was received on 15-Dec-2021 from other non-healthcare professional via agency (reference number: SEQW21-06167) and concerned 46-year-old, female patient.   The patient's medical history and concomitant medication were not reported. The patient had no allergies.  On 14-Dec-2021 05:00 p.m., the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced body aches and fatigue. During the night, she had a bit of fever and she did not sleep well. She managed to work today but had to take a long nap and still she felt very tired. The patient took Tylenol and Advil as treatment for events.  The outcome of events was unknown.  The reporter assessed the case as non-serious.  All events were assessed as non-serious.  Company comment: A 46-year-old female patient experienced general body pain, pyrexia, fatigue and sleep disturbance on the same day after receiving Flucelvax Quadrivalent vaccine. Causality for sleep disturbance is assessed as not related due to biological implausibility. Based on plausible temporal relationship, causality for the other events is assessed as possibly related.; Sender's Comments: A 46-year-old female patient experienced general body pain, pyrexia, fatigue and sleep disturbance on the same day after receiving Flucelvax Quadrivalent vaccine. Causality for sleep disturbance is assessed as not related due to biological implausibility. Based on plausible temporal relationship, causality for the other events is assessed as possibly related.
Very strong tingles on both feet & hands just hours after getting H1N1 vaccine that are still occuring all day.  Went to the doctor on 11/13/09 & he said that it was not serious but to go to the ER if more serious symptoms appear.  On 11/14/09, I went to the ital ER because I was getting cramps in my calves & was worried it was Guillain-Barre Syndrome.  Doctor said I did not have Guillain-Barre at that time but could not explain the tingles on both hands & feet.  The ER doctor did not do extensive tests.  He just checked vitals & asked me to move around to check paralysis.  It has been 5 days since getting the H1N1 vaccine & I'm still feel lethargic & have tingles on my hands & feet.   I'm a very athletic, energetic woman & I KNOW something is wrong with my body ever since I got the H1N1 shot.
GENERALIZED WEAKNESS, SOB, TACHYCARDIA, LE WEAKNESS 8/29/2021 HOSPITALIZATION 8/29/2021 DISCHARGE 9/1/2021
After 1 vaccine Fatigue and headache approx 8 hours after shot - resolved without medication. Did not miss work  After 2 shot, Fever and chills approx 14 hrs after the shot.  Resolved after 24 hours - took fever reducing medication- combination  Advil and Tylenol Headaches, pain at the injection site, arm pit pain missed one day of work
This spontaneous report as received from a physician refers to a unspecified number of patient of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received (Oka/Merck) VARIVAX (lot# K009727 and expiry date: 07-AUG-2015) which was improperly exposed to 22F for 4224 hours. No known adverse effects reported.  No product quality complaint was reported for (Oka/Merck) VARIVAX.     This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. On 14-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009387.
At first on April 23rd, my tongue felt like it was burned and tingling.  By 4/26 I woke up with right side of face dropping, swollen, and paralyzed.  Went to the ER and was diagnosed with Bells Palsy.  ER doctor also performed CT scan which was normal.  Was given prednisone and valacyclovir, instructed to protect and dress my eye.  The right side of my neck under my ear is very swollen and tender.  I have pain in the back of my neck on the right side.  I had a follow up with PCP 5/05/21.  She told me to use an eye ointment.  It has been two weeks and my face is still paralyzed.  Some of the swelling has gone down in my check.
Pain along side for 2 days (shooting pain along ribs). Broke out with blisters 2 days after the pain started. Spot approximately as big as an egg on left back. Small strip 1'' x 1/4'' under left breast.
Almost two weeks later, below the injection site the area is warm, red and hard.  The circumference of the red area is about baseball size.
The adverse event lasted 48 hours, it was just like when I had covid, big time headache, lethargic. A week after I experienced itching , depending upon the day or time it would present itself in different parts of the body. When it started it was horrific on the bottom of my left foot. I went to Urgent Care they gave me hydroxyzine 25 mg, I took it for 2 days, I had to stop taking it because it made me too tired.
receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (patient had received 2 doses of the Pfizer's COVID19 vaccine).    On 26-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine). On 26-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.
3-4mm diffuse macular, blanching rash on the trunk. Myalgia, fatigue, Tmax 100.5F, sore throat, headache.
Growing red spot at injection site; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Aug2021 at 16:30 (at the age of 48-years-old), as single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Concomitant medications were not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN), clindamycin (MANUFACTURER UNKNOWN) and ketorolac tromethamine (TORADOL); all on unknown dates for unspecified indications and experienced drug allergy. On 09Aug2021, the patient experienced growing red spot at injection site started a week after receiving vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event growing red spot at injection site was not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
got pale and then passed out; got pale and then passed out; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (got pale and then passed out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unavailable) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (got pale and then passed out) (seriousness criterion medically significant) and PALLOR (got pale and then passed out). At the time of the report, LOSS OF CONSCIOUSNESS (got pale and then passed out) and PALLOR (got pale and then passed out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were reported. It was reported that the event happened during the 15-minute waiting period after receiving the Moderna Covid-19 vaccine.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, serious, event Loss of Consciousness which was medically significant. As reported, the patient got pale and passed out after receiving a booster dose of the mRNA-1273 vaccine, this happened during the 15-minute waiting time after vaccination. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the evens was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, serious, event Loss of Consciousness which was medically significant. As reported, the patient got pale and passed out after receiving a booster dose of the mRNA-1273 vaccine, this happened during the 15-minute waiting time after vaccination. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the evens was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
About a half hour or 45 minutes after shot my vision was distorted in both eyes. It was almost as if there was a ripple effect when looking at an object, combined with a rainbow like effect when lights were bright. I could look at a wall and it was as it it was reverberating. When looking at text on a screen I was able to see either side of the text but not the middle. This lasted about an hour and thankfully my vision returned to normal. I now have tiredness, a sore arm and slight headache.
we started the day giving J&J and the pt were suppose to get the second dose of moderna. pt got the first dose some where else and mistakenly were giving J&J instead of second moderna. pt was ok since he is fully vaccinated now.
Chills, Nausea, Vomiting, Fever, Fatigue, joint pain, stomach cramps, diarrhea
A purchasing agent reported that an unidentified child received Diphtheria and Tetanus Toxoids Adsorbed, Purogenated (diphtheria and tetanus toxoids, aluminum phosphate-adsorbed) and experienced an "unknown reaction". The reporter states that the mother thinks it may have been due to thimerosal. No additional information was available as of the date of this report. Follow-up information received on 2/20/02 from pediatrician. The adverse event was identified as a "transient fever". The pt recovered.
Temp of 102.5.   Aches Chills Short breath (spouse opinion)
This spontaneous report was received from a back office lead referring to a 47-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 18SEP95 & 30SEP95 pt devel a rash;no further details were provided;
This spontaneous case was initially received on 16-NOV-2015. This case report was received from a(n) Health Professional and concerns a(n) 40 years old female patient. The patient received AFLURIA, batch number: not provided) last year and no complaints were reported post-vaccination. Weight: not provided, Height: not provided. For concomitant medications and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction9s)/event(s): The patient received AFLURIA for indication Active immunization against influenza disease caused by influenza subtypes A and type B present int he vaccine on 30-OCT-2015 - unknown stop date. Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, AFLURIA was stored correctly. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced Pain in the arm/Pain is limited to the arm of the injections site (non serious, outcome: Unknown, Pain worsens when lifting objects and reaching over her head (non serious, outcome: Unknown). Reporter's assessment: n/a
injection site irritated; injection site warmth; injection site itchy; injection site hard; injection site redness; A spontaneous report was received from a consumer concerning a female  81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site was red, hard, itchy, irritated, and warm.  The patient's medical history was hypertension . Concomitant medications reported were Losartan, Atenolol, Omeprazole for drug use for hypotensive medication.  On 16 Feb 2021, prior to the onset of the events the patient received first dose of two planned doses of mRNA-1273 (lot/batch: MR101434738) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) injection site was red, hard, itchy, irritated, and warm.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), injection site was red, hard, itchy, irritated, and warm was unknown.
Papular, pruritic rash on back 1"x2" area, muscle aches. Using ibuprofen, dyphenhydramine and hydrocortisone cream.
Hives on body, (both sides of body) arms, legs, face, trunk of body; Pt went to physician, dr said it was allergic reaction, prescribed cetirizine and "topical cream".
Woke up from nap was very out of sorts and off balance almost fell, feeling something was not right. This feeling of not being right continued into Monday and his emotions were out of the normal, crying, upset more than usual, feeling off. Tuesday he had a stroke.  We were told by ER Doctor to report. I am just now reporting because my husband has been in out and of hospital with complications from the stroke.
Patient called COVID Nurse Hotline with c/o headache for 3-4/days with pressure, positional and accompanied with nausea. This is day 11 post vaccine