chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 7-8 days following his second vaccination via Pfizer he began having symptoms of a knot in his Left leg that then began to painfully spread down the leg. He presented to ED on 26NOV and was found to have "extensive left lower extremity deep venous thrombosis from the level of the proximal superficial femoral vein into the calf".  He then was started on apixaban and the following morning was awaken from sleep 2 hours sooner than expected by 2-4/10 pleuritic chest pain; he then represented to the ED on 27NOV and was found to have 7-10/10 pain in the left lower leg requiring opiate pain management and CT Angiogram Chest PE Protocol showed "bilatera pulmonary emboli".
Local reaction at injection site with erythema 5-6 cm in size. Hard with           Hot to touch. Blister at injection site.
Sudden onset of chest pressure with weakness and numbness in hands and legs. Systolic blood pressure on presentation to the ED was 235, indicating hypertensive emergency.
PC 2pm c/o numbness moved down L arm into fingers. No other problems. Felt numbness at site after injection. No c/o's at tha time. Did light exercise this am after injections. 3:40 numbness is subsiding, much better. 3/6/03 no problems.
Immediately following administration of .5 mL TENIVAC, donor appeared clammy and lost color in face. Then, the donor lost consciousness for approx. 20 seconds. Center Medical Specialist lightly pinched the donor's trap to awaken the donor. Donor's feet were elevated. Donor again lost consciousness for approx.30 seconds. After laying down for approx. 15 minutes, the donor stated he felt well enough to sit up. Donor was given Powerade and a granola bar. From onset of event to time donor was well enough to leave the facility, was about 35 minutes.
Pt. received 4 immunizations on 5/27/08.  DTaP #5,  IPV #4,  MMR #2 and Varicella #2.  DTaP was administered IM in LT.  It developed a knot at the site and later that day became hot to the touch and started to swell.  Next day it was the size of a lemon (7 x 7 cm).  On day 14 post immunization the site has no swelling, reddness or heat, it does however  have a discoloration where the reaction occurred.
Immediate purple discoloration and swelling after administering Typhim Vi, swelling increased over 10 min time to 30x45 mm with defined edges.  No other signs or symptoms while patient was in clinic.  Pt observed for 30 min post injection
I began to feel within 3 hours, fatigued, muscle pain, joint pain, and slept from one until eleven, loss of appetite, and headaches came along as well. I am still experiencing the headaches and contacted clinic to have a telehealth visit. The left side above my nose began to ache. Then I went to the doctors in person who then told me to speak with my ophthalmologist, The doctor prescribed Rizatriptan 5mg.  Appetite has returned, with a history of Rheumatoid Arthritis, I still have joint pain however the main symptom that seems to still linger is the headache.
Body aches, severe nausea, GI upset on 2-13-21 Next day still had severe nausea, GI issues, stomach pain 3rd day, still severely nauseated, frequent stools, pains in stomach even with sips of water.  My stomach is still very sore, headache and nauseated, but getting better.
the patient felt very hot and sweaty shortly after receiving the vaccine.  She also noted some visual impairment as well.  We provided an ice pack and some water and she felt better.  She stayed in the pharmacy for 30 minutes after administration.
Systemic: Flushed / Sweating-Medium, Additional Details: at 12:11pm pt was sweating and very hot, turned on fan whil ewaiting for 15min, pt left with mom at 12:36pm no other issues reported
Rash at injection site 8 days after shot.  ("Covid arm") Rash is slowly going away 3 days after it appeared.
Mild episode of paresthesia and weakness to right arm that resolved after several minutes. Occurred 3 times on different days within 5 days of 2nd vaccine dose. Asymptomatic at this time with no neurological deficits
Fatigue, muscle soreness, body aches, and hives.   Hives were only thing treated, went to ER because it was all over entire body. was given steroids and Benadryl. after follow up was given an additional steroid shot.
pain down left side; SWOLLEN LYMPH NODE IN ARM, SWOLLEN LYMPH NODE IN JAW; feeling run down; ARM SORENESS; FATIGUE; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (ARM SORENESS), FATIGUE (FATIGUE), LYMPHADENOPATHY (SWOLLEN LYMPH NODE IN ARM, SWOLLEN LYMPH NODE IN JAW), FATIGUE (feeling run down) and PAIN (pain down left side) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L201A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (ARM SORENESS) and FATIGUE (FATIGUE). On 27-Jan-2021, the patient experienced LYMPHADENOPATHY (SWOLLEN LYMPH NODE IN ARM, SWOLLEN LYMPH NODE IN JAW) and FATIGUE (feeling run down). On 28-Jan-2021, the patient experienced PAIN (pain down left side). At the time of the report, VACCINATION SITE PAIN (ARM SORENESS), FATIGUE (FATIGUE), LYMPHADENOPATHY (SWOLLEN LYMPH NODE IN ARM, SWOLLEN LYMPH NODE IN JAW), FATIGUE (feeling run down) and PAIN (pain down left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient is on birth control, diuretic for acne. Treatment details are not provided.
I was given the vaccine on a Friday night and by Sunday, I was unable to get out of bed without assistance. My husband helped me with his arms to get to the bathroom. I had severe pain in my body from the neck down. I had to walk by holding onto the walls. Continuous testing was initiated and continues on a monthly basis.
I got my vaccine on the 8th and it is now the 10th. I've been having the runs since the 9th.
Since  second dose, unable to enter deep sleep cycle to stay asleep. Sleep was very light and unable to stay asleep. Sometimes waking up early in the morning due to unable to enter deep cycle.; Since  second dose, unable to enter deep sleep cycle to stay asleep. Sleep was very light and unable to stay asleep. Sometimes waking up early in the morning due to unable to enter deep cycle.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 09Apr2021 at 14:00 (at the age of 37years-old) as a single dose for COVID-19 immunisation. Medical history not was reported as no. The patient had no known allergies to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate (FLONASE) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 23:45, since second dose of vaccination, the patient experienced unable to enter deep sleep cycle to stay asleep and sleep was very light and the patient was unable to stay asleep. Sometimes the patient  woke up early in the morning because he was unable to enter deep cycle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events unable to enter deep sleep cycle to stay asleep and sleep was very light and the patient was unable to stay asleep. Sometimes the patient  woke up early in the morning because he was unable to enter deep cycle was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
EXPERIENCING TICS (BELOW CHEEKS) AFTER 2 HRS FROM THE FLU SHOT WITH PRESERVATIVE. THIS IS THE FIRST TIME SHE IS GETTING FLU SHOT WITH PRESERVATIVE. LAST YEAR SHE HAD FLU SHOT WITHOUT PRESERVATIVE.
PT. DEVELOPED SWELLING AT SITE OF INJ. SOON AFTER ADM. AND STATED FEELING DIZZY. PT. PLACED IN SUPINE POSITION WITH LEGS ELEV. ICE PACK APPLIED TO SITE AND VS TAKEN. B/P 104/68, HR 64, 0XYGEN SATS 100%. AFTER 12 MIN. PT. STATED FEELING BETTER AND WANTING TO SIT UP. ASSISTED TO SITTING POSITION AND VS MONITORED WHILE SITTING BEFORE BEING ALLOWED TO STAND. B/P 113/70, HR 68, 02 100%. NO DIZZINESS STATED, NO SOB NOTED, NO RASH PRESENT. SN AND DR. PRESENT WITH INSTR. TO CALL 911 OR GO TO ER IF SOB, SWELLING OF LIPS, OR WORSENING OF S/S,AND TO CONT. TO USE ICE PACK TO AREA Q 20 MIN ON AND Q20 MIN OFF AS NEEDED.
RAPPID HEART RATE, TROUBLE BREATHING, SHAKING, HOT AND COLD SWEATS, DANGEROUSLY HIGH BLOOD PRESSURE, PANIC ATTACKS
Red rash around injection site for 6 days (2/1-2/6/21).   It was hot to the touch and had some burning and itching. toward the last couple of days of the rash.
Fever 101, chills, headache, joint pain, body aches. Duration: 48 hours
Case number PHEH2014US004355 is an initial spontaneous report from the nurse received on 28 Feb 2014. This report refers to a 08-year-old male child. The patient was vaccinated with FLUVIRIN (batch number: 1301P) intramuscularly on 25 Oct 2013. It was reported that the FLUVIRIN vaccine which was given the patient was exposed to temperatures down to 32 F for an unknown period of time before vaccination. No adverse event occurred to the patient after this medication error.
At ~9:30 p.m. that night, my right arm became increasingly sore.  By the time I got to bed at around 1:30 a.m., it was so sore I could not put pressure on it and avoided sleeping on it.  By the next morning, my arm was so sore that I couldn?t raise my right arm without significant pain.  I took my BP at 11:48 a.m. and it was 109 over 76 (although I think that this BP machine reads too low), and my heart rate was 100 BPM which is high for me.  By around 1:30 p.m. I began feeling tired, feverish, and achy, particularly in my lower back.  By 2:30 p.m. I knew I was feverish.  I finished lunch and sat in my rocker/recliner for awhile.  I had planned to go for a 1-mile walk, but was feeling so rundown, that I decided not to do that.  I laid down in the recliner instead for awhile.  By about 4:45 p.m. I decided to go out to the field by my house and stand and do bird photography. I didn?t think that it would cause me any problems since it is rather sedentary and the temperature was ~77ºF.  I still felt chilly, so I wore a light sweatshirt over the long sleeve shirt and t-shirt that I was already wearing.  I did feel though that it was all a little taxing.  At 5:17 p.m. as I decided that I should go in and lie down, my smart Watch gave me a warning that for the prior 10 minutes my heart rate had been over 100 BPM, and it knew that I wasn?t exercising.  I went inside and tried lying in the recliner.  I checked my heart rate and it was 109 BPM.  I decided to try some calming guided meditation to bring my heart rate down.  After 15 minutes of meditation, my heart rate was down to 96 BPM.  By around 5:50 p.m. I decided to go upstairs and take a nap.  I got up at 6:30 p.m. and decided to take my temperature.  It was 99.8ºF.  (My basal temperature is usually ~97.6ºF  Spoke with Dr. (my Primary) at 7:26 p.m.  He suggested hydrating, taking tylenol, and making an appt. with the Nurse Practitioner at 8:00 a.m. if I wasn't feeling better by the next morning.  Took my pulse at ~8:00 a.m. 10/22/2021 using my smart Watch.  It was back to normal at 78 BPM.  Soreness in arm was almost gone, and I didn't feel feverish anymore.  Friday afternoon (10/22/2021) noticed an itchiness on my right arm 4?-5? below the deltoid muscle where the shot was administered.  No apparent rash, but the itching persisted through Sunday (10/24/2021).
HOT & COLD FEELING; HEAVY PAIN IN LEFT CALF WHEN TOUCHED IT; FEELING LIKE GETTING SICK/LAYING IN BED MOST OF THE TIME; PAIN IN ARM AT INJECTION SITE; SLIGHTLY STUFFED UP NOSE; CALF LITTLE HOT TO TOUCH; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and  expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced calf little hot to touch. On 25-MAY-2021, the subject experienced slightly stuffed up nose. On 25-MAY-2021, the subject experienced hot & cold feeling. On 25-MAY-2021, the subject experienced heavy pain in left calf when touched it. On 25-MAY-2021, the subject experienced feeling like getting sick/laying in bed most of the time. On 25-MAY-2021, the subject experienced pain in arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm at injection site, had not recovered from heavy pain in left calf when touched it, feeling like getting sick/laying in bed most of the time, slightly stuffed up nose, and hot & cold feeling, and the outcome of calf little hot to touch was not reported. This report was non-serious.
chills; Fever of 103 degrees Fahrenheit; Exhaustion; This is a spontaneous report from a contactable consumer.  A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, in right arm on 23Feb2021 at 16:45 (at 29 years) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. Previously on  02Feb2021 at 04:45 PM (at 29 years) patient took the first dose of the vaccine in right arm for covid-19 immunisation.On 24Feb2021at  01:00 am (also reported as approximately 12 hours after receiving the vaccination) the patient displayed symptoms of chills, exhaustion and a fever of 103 degrees Fahrenheit.No treatment given an outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
20-25 mins p/vax pt stood up to leave fell backwards onto floor; 334PM on 0.2cc Epi 1:100; skin very pale at diaphoretic, lethargic, very drowsy et difficult to keep alert; opens eyes when spoken to; t97.8; pupils enlarged slow to react;
some kind of reaction; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and ADVERSE REACTION (some kind of reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea) and ADVERSE REACTION (some kind of reaction). At the time of the report, NAUSEA (nausea) and ADVERSE REACTION (some kind of reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
lost a little bit of action in the limbs of my legs; This is a spontaneous report from a contactable consumer. This consumer (patient) that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter was just calling discuss side effects of the shot. Patient got a little bit of confusion going on and patient have lost a little bit of action in the limbs of his legs. Consumer asking is that possible? Is it actually FDA approved?" Consumer also added, "I had it back 5 days ago. "Consumer was informed about Pfizer Medical Information Department. Consumer stated, "It is FDA approved you say? So, who do I talk to about the side effects of the shot that I have so this not FDA approved?". The outcome of event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
7 years old patient was given Fluzone High Dose by mistake/ No AE; 7 years patient was given Fluzone High Dose by mistake/ No AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA257547 same reporter.  This case involves a seven years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ246AA via intramuscular route in the right thigh on 09-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
had chest pain - was admitted to hospital with elevated troponin and was ultimately diagnosed with acute myocarditis.  Was admitted on 4/25 and discharged on 4/27 - symptoms resolved within a week.
abdominal pain since vaccine, found to be pregnant.  headache 1 week after vaccine. normal exam. no change in vision. no personal or family history of clots. better with reglan
This spontaneous report was received from a Registered Nurse refers to a 7 unspecified patients of unknown age and gender. The nurse reported that between 27-AUG-2013 and 06-SEP-2013, the patients received unspecified doses (in schedule) of GARDASIL (lot # H021861, expiry: 09-OCT-2015) 0.5 ml, intramuscularly. Nurse stated that the GARDASIL doses were exposed to 31F maximum for total of 1.5 hours cumulatively on 27-AUG-2013. No adverse effects reported. Follow up information has been received from the registered nurse, who stated that after reviewing office records, 4 patients (previously reported as 7 patients) had received the vaccinations. The patient identifiers were given and dates of birth. The patient had 15 years old. This case is related with MARRS 1309USA003768, 1309USA012208, 1309USA012209. Additional information has been requested.
I started experiencing symptoms of sinus pressure, headache, chills, congestion, and weakness. I took an at home COVID test that was positive. I called my doctor and she came to my house and I received the anti-body infusion yesterday.
Swollen at injection site with redness and itching. Palms on both hands are red and itchy. Arm is a little sore.
pt recv vax & taken to ER because was breathing funny;nurse @ hosp said no distress noted & low grade temp;although reported to clinic nurse that t101.8 R;MD @ ER wrote that pt had fever secondary to DTP & thrush;
This spontaneous report has been received from a physician referring to a 17 year old male patient. The patient had no history of allergies and other medical history was not provided. On 12-NOV-2012, the patient received the first dose of GARDASIL (dose, route, lot number and expired date unknown). On 12-AUG-2013, the patient received the second dose of GARDASIL (dose, route, lot number and expired date unknown). There were no reactions after receiving first and second doses. On 21-APR-2016 the patient was vaccinated with GARDASIL 9 (dose 3, 0.5 ml, intramuscular, lot number and expired date unknown) (inappropriate schedule of vaccine administered and interchange of vaccine products). There was no concomitant therapy. After the third dose of GARDASIL 9 on 21-APR-2016 (inappropriate schedule of vaccine administered), the patient experienced hives at the injection site and numbness, specified to his face; these symptoms had lasted about 4 weeks and continued. No laboratory test was performed. On 19-MAY-2016, the patient visited physician's office and no treatment was employed, but she was considering recommending unspecified antihistamine. The outcome of adverse events was reported as not recovered. Additional information has been requested.
severe headaches on almost daily basis toward end of day, have needed to take my migraine perscription medication to alleviate pain
Excessive bruising in the last 2 weeks.  Patient initially noted red spots on her bilateral lower legs which has now spread to her torso. She was found to be thrombocytopenic with a platelet count of 3000.  Her CMP was notable for mildly elevated alkaline phosphatase of 316. Coags were normal.
Pt experience soreness on back torso, low grade fever and profuse runny nose. Advise pt to take antihistamine (CLARITIN or ZYRTEC) pt have available and take TYLENOL for fever. Advise pt to see medical attention if worsen or doesn't subside in next few days.
Moderna COVID-19 Vaccine EUA: Developed an area of rash with swelling, erythema, warmth, and pruritus to the vaccine injection site on the left arm, which was first noticed on Saturday 1/16 (8 days after receiving the vaccine). Visited urgent care on 1/17,  believed to be an infection; was prescribed oral antibiotic as well as an antibiotic cream. Later visited ER,  site of vaccination, where it was diagnosed as a delayed localized reaction to the vaccine. Recommended Benadryl and hydrocortisone cream for supportive treatment; prescribed an Epi-pen just in case. Rash currently appears to be improving.
Patient received only the adjuvant; Patient received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   On 16th March 2022, the patient received Shingrix. On 16th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The Medical assistant reported that the patient received only the adjuvant of Shingrix, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
Vaccine used is recommended for adults less than 64 years old. Patient received vaccine is 67 years old.