chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at approx 1:00 AM the day after my second shingles booster shot with severe chills. Got worse and could not control the chills unless laying perfectly still. If i moved an arm or leg or tried to roll over, i would just get them worse. Piled on blankets and layed as still as i could and they subsided at about 4:00 am. Finally got some rest and then got up and researched the symptoms and so was somewhat relieved as i had not thought of the shot being  the cause as was fearful of Covid or something else going on. I had pretty bad body aches, headache and had some nausia  feeling , but never did get sick and took IBprofin, etc and that knocked that down. Did have pretty good swelling, soreness and redness about 4 x 6 inches and that remained until yesterday morning. (9-10-21) and it is still sore, but looks and feels much better this morning with no other side effects.
This spontaneous case, initially received on 30-Dec-2016, was reported by a health professional and concerns a 3-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 29-DEC-2016 to 29-DEC-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: WT53606. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Dec-2016, administered AFLURIA to a 3 year old child (outcome: not reported, special circumstances: drug administered to patient of inappropriate age), no adverse effects were noted (outcome: not reported). Reporter comments: The healthcare professional considered all events as non-serious.
DTAP 4th dose administered at 2:55 pm, 3:00 pm child began to break out in whelps and rash on face, arms, and upper torso. V/S B/P 76/50 P100 R100. Epinephrine administered per protocol, child transported by parents to PCP.
Diffuse swelling and tenderness over the left upper chest, axilla, and trapezius area
On Monday, October 30, the patient received a pneumococcal vaccine and over a period of 48 hours he developed a progressive swelling and extreme tenderness over the site of the injection on the left arm.  On November 2 he was seen by M.D. and patch of 7 x 8 cm of erythema and induration that on the previous day had been quite small had enlarged and spread to the medial aspect of the arm.  The patient had significant induration and the overlying skin was warm and despite the fact that the patient had been trying to use cold compress to obtain relief he was quite uncomfortable.  The patient also had a temperature that was documented to 101.5.  It should be noted that all these reactions occurred while the patient was receiving linezolid. 11/28/06 Received medical records from hospital which reveal patient admitted 10/16/-10/30/06 w/Dx: excerbation of cystic fibrosis of increased cough, production of purulent sputum, increased fatigue, renal dysfunction, vomiting/diarrhea & general malaise.  Also had lost approx 20# over past 2-3 mo.  Received IV antibiotics.  Consults by pulm & ID.  Improved significantly.  Was given flu & pneumo on day of d/c to home. D/C DX: acute exacerbation of cystic fibrosis, improved; renal insufficiency, resolved; & electrolye imbalance, treated. Patient was readmitted to hospital approx 48 hours after receiving vax w/severely swollen arm w/pain, limited mobility, fever, redness, induration & edema extending from lower deltoid to elbow.  Admitted 11/2/06 & d/c 11/5/06.  Treated with IV antibiotics.  Developed & was treated for candida.  Improved significantly & was d/c to home on continued oral antibiotics. D/C DX: severe reaction to pneumococcal vax w/cellulitis & sterile vaccine reaction; cystic fibrosis, stable; recovering from recent CF exacerbation; chronic hypokalemia & hypomagnasemia; & candidiasis. Patient was febrile on 2NOV06
I am post menopausal for 2 years , not even spotting in that time, yet the evening  after he vaccine , I started heavy vaginal bleeding for 4 days , along with severe headache , body aches and exhaustion , the body aches lasted 1 day ,  i continue to have a mild headache and exhaustion .
Achy left ear, paralyzed left side of face, left side of mouth paralyzed, left eye would not close or blink.  This started the day after the vaccine injection.  The facial paralysis lasted 5 weeks.  The leg pain started 3 weeks after injection.
Patient was sitting on a chair in the recovery area after receiving the vaccine and slumped over and fell off the chair (seeming to have fainted) He hit his head when he fell off the chair and bit his tongue. He regained consciousness immediately and was talking and coherent. We monitored pulse and breathing and kept him talking. We called an ambulance immediately and his parents. Ambulance personnel came and evaluated the patient and released him to his parents with the recommendation to monitor the patients and have him further evaluated if necessary.
Red rash on left arm; Warm rash on left arm; Itching on arm; Rash on face; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on left arm), SKIN WARM (Warm rash on left arm), RASH PRURITIC (Itching on arm) and RASH (Rash on face) in a 65-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on left arm), SKIN WARM (Warm rash on left arm), RASH PRURITIC (Itching on arm) and RASH (Rash on face). At the time of the report, RASH ERYTHEMATOUS (Red rash on left arm), SKIN WARM (Warm rash on left arm), RASH PRURITIC (Itching on arm) and RASH (Rash on face) outcome was unknown.            No concomitant medication was provided by the reporter. No treatmrnt medication were provided by the reporter.
HEADACHE; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 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 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 08-APR-2021. This report was non-serious.
Injection site reaction- Pt had redness, swelling and pain beginning approximately 48 hrs after administration; swelling was larger than golf ball and spread down back of arm. Pt was diagnosed w/ cellulitis and given Abx tx.
Patient reported swelling of the face.  Swelling was more on the left side.  Treated with Benadryl and Ice.  Pt will follow up with Primary Dr or go the ER if worsening of ADRs.  Pharmacy faxed Dr about ADR.
a fluid filled blister appeared the next day at injection site, no redness or other symptoms, as of day 6 after vaccine the blister has burst and is scabbed over.  no other symptoms
Pain, swelling, redness on right thigh at site of injection, 3-4 hours after. Seen in ER. Kept overnight in hospital because of tense swelling. Rx'd with Benadryl and Motrin, responded well.
Runny nose and congestion day following vaccines until now (10 days after), fever of 102 eight days after vaccines lasting two days, and rash on back/torso/neck/face present 9 days after vaccines and still present at 10 days after vaccines. Treated fever with Tylenol, and not treating the rash because it does not seem to be bothering the baby.
Rash (fine) all over body-spreading 90 severe. Itching-circular raised rash around. Injection site-received Zyrtec and po Benadryl
1 of 5 pts vaxed during the month of April from the same lot# who exp a local rxn @ vax site;rxn described as enlarged, swollen, red & painful;exp diff moving immunized arm for several days;recovered
REDNESS ON ARM; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be requested for this case  No concomitant medications were reported. On an unspecified date, the subject experienced redness on arm, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and redness on arm was not reported. This report was non-serious.
This is a spontaneous report received from a noncontactable consumer or other non-HCP. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced vaccination site reaction (one of their vaccine recipients had a reaction with the vaccine), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Began with itching hands and feet, spread rapidly to entire body.  Skin burning.  Next day severe abdominal pains, spreading to back, abdomen swollen and very tender.  Unable to eat at all for 2 days.  Joint and muscle tenderness.  6th day blood pressure elevated, dizziness, weakness. abdomen still swollen.  Visited doc. 7th day, gave meds to try and lower BP.  Thinks elevated BP from fluid retention from swelling.  Continue to have mild itching.  Abdominal pain less and am able to eat.
Erythema multiforme: rash on neck, back, extremities, since 8/9/04. 1st Rabies vaccine given 8/6/04. Vaccine given at hospital.
Was contacted by parent of client regarding a reaction to an immunization on September 18th, 2018. Parent reported redness, induration and tenderness of the right post arm of child. Parent stated that child did not have a fever. Parent requested to have child seen at Public Health. Parent and child presented on September 19th, 2018 at 16:00. Child stated that arm did not hurt. When area of redness was touched, child retracted arm. Right post arm was red, cool to the touch and measured 20 cm in diameter. In comparison, the left post arm measured 19 cm. Child was active and responsive during visit. Advised parent to continue to monitor site and if symptoms were to worsen, child should be taken to a care provider.
On 12/20/2021 Chief Complaint Patient presents with o Shortness of Breath     Covid+ x1 week, reports trouble breathing since this morning. Lives with daughters at home.   89-year-old female with history COPD, diabetes mellitus, reflux disease, hyperlipidemia, hypertension and thyroid disease reports that she was diagnosed with Covid 19 about a week ago. She's felt weak. She's had shortness of breath. She has lost her sense of taste. No diarrhea. No chest pain. She is vaccinated. Her SPO2 was 87% on arrival. She is not on home O2.
pt recvd vax & mom reported pt was very fussy all noc, had a high pitched whining cry & woke @ least every 2 hrs; pt given APAP q 4 hrs & that pt felt feverish; pt exp jerky motions, eyes looked funny, glazed over, frothy mouth; t101;
Info has been received on 11/13/2002 from a physician's assistant concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent, in the arm. Concomitant therapy that day included a dose of influenza virus vaccine, in the opposite arm. Subsequently the pt developed a site reaction characterized by pain, swelling and redness. It was described as an Arthrus reaction with a fever of 101 to 102 degrees F. The pt sought unspecified medical attention. Additional info has been requested.
Tingling in the upper limb; Rash in the hand; Shaking; Fever; Headache; Shivering; This case was reported by a nurse via call center representative and described the occurrence of tremor in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 33TL7, expiry date unknown) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, 12 hrs after receiving Shingrix, the patient experienced tremor, fever, headache and shivering. On 17th October 2020, the patient experienced tingling and rash. On an unknown date, the outcome of the tremor, fever, headache, shivering, tingling and rash were unknown.   It was unknown if the reporter considered the tremor, fever, headache, shivering, tingling and rash to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that a patient received the 1st dose of Shingrix and within 12 hours she developed side effects such as shaking, fever, headache, shivering.  On 17th October 2020 she developed a rash in her hand and tingling in her upper limb. Nurse did not have the expiration date of the dose and mentioned that she did not administer so she didn´t know if it was given by the IM route. The reporter consented to follow up.
Patient reported tingling in left hand late Fri, 1/28/10, night into Saturday, circumoral tingling for 3 days, which abated on Mon 2/1/10, then swelling of lip in AM on 2/2/10. Instructed to contact his physician immediately for follow up and further evaluation.
pt recv vax 19OCT95 & 22OCT95 pt went to ER because the inj site was red & swollen;tx w/DPH & Ancef;sx abated by 25OCT95;
swollen lymph; lump and it is painful; lump and it is painful; pain in arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 08Nov2021 (Lot number: FH8028) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: FF2590, Route, Anatomical Location: left arm), administration date: 16Oct2021, when the patient was 47 years old, for COVID-19 Immunisation. The following information was reported: AXILLARY PAIN (non-serious) with onset 08Nov2021, outcome "not recovered", described as "pain in arm pit"; LYMPHADENOPATHY (non-serious) with onset 09Nov2021, outcome "not recovered", described as "swollen lymph"; MASS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 09Nov2021, outcome "not recovered" and all described as "lump and it is painful". No follow-up attempts are possible. No further information is expected.  Follow-Up (15Nov2021): Follow-up attempts are completed. No further information is expected.  Additional information: Time the Vaccination Was Given: between 2PM and 3PM.
Pt received shot in right deltoid. Pt claim right shoulder caused bursitis and lymph enlargement.
Pain at injection site right arm, hard to move arm for first day (5 hours after injection).
Immediately upon vaccination, the site bruised and swelled @ 2cm diameter and 1cm high
Moderate redness and swelling to injection site with mild pain and itching to area. Started day after vaccination and has not changed since presenting to me today. Treated with hydrocortisone 2.5% cream as OTC hydrocortisone seems to be providing some relief.
Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness.  Pfizer vaccine was given at 11:45 AM and reaction onset at 11:55.  VS at 12:10: BP 132/67; HR: 100; O2 96%;  Epi given at 12:22; Was taken to ED for observation.  Patient has PMHx of RA and Asthma; Meds include Methotrexate, Advair, Omeprazole, Vit D; Allergies to PCN and Percocet; Had anaphylactic reaction to sucralose for fit test.
Shingles began 14 Aug 21, 3 days after receiving the 1st dose of Pfizer.  Began with fatigue, malaise and skin/nerve pain in right elbow. Few days later skin/nerve pain in right leg centered above and below right knee. Starting 20 Aug 21, shingles skin rash presented on right torso and center of stomach.  Headache/fatigue began 25 Aug 21.
Patient had a sore arm and achiness for 2-3 days after the shot, but then a week later on 2/10/21, she developed a hard knot at the site that was red.  The red coloring has intensified today, 2/11/21, and the knot is palpable to the touch.  She is also running a low grade fever that she was not running before.  Patient is concerned there may have been something in the vaccine that caused her an allergic reaction.
pt called stating that she had a golf ball size lump on her arm approximately 2 days after injection
Red area about 4cm on left thigh, small bump with clear drainage. No fever. Treated with Bactroban cream tid X 5 days, warm compresses and massage.
Administered vaccine to patient and not long after patient stated he wasn't feeling well and fainted. Had technician call 911.  Paramedics came and accessed patient. Patient was asked if he wanted to go to the hospital and he refused. Currently patient has recovered and called for a ride home
cold; slight cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and COUGH (slight cough) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and COUGH (slight cough). The patient was treated with CEFDINIR for Cough and Cold, at a dose of 300 mg, for 8 days. At the time of the report, NASOPHARYNGITIS (cold) and COUGH (slight cough) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient is supposed to be getting the booster shot on Saturday 20-Nov-2021. The doctor has had him on antibiotics because he had a slight cough and cold. He has been taking cefdinir 300 mg for 8 days; he still has another 2 or 3 days.
My daughter slept for 8 hours waking only once for feeding.  Usually would sleep no more than 1.5 hours at a time with periods of wake in between. Very sleepy and lowered appetite.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ, orally for prophylaxis (dose number, lot # and expiration date were unknown), which were improperly stored at 1 Celsius degree for 17 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA013570: US-009507513-1704USA013571: US-009507513-1704USA013572:
Right side of the neck became stiff; Right eye started having a blinking tick; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 24Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 03Mar2021 at 12:30 as a single dose for COVID-19 immunisation. On 24Mar2021 at 16:00, the patient's right side of the neck became stiff and also right eye started having a blinking tick. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events right side of the neck became stiff and also right eye started having a blinking tick were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning her 86 year old mother with a history of shingles. On 04-APR-2007 the reporter was vaccinated SC with a dose of Zostavax. On 11-APR-2007 the patient (the reporter's mother) was diagnosed with post herpetic neuralgia after coming in contact with the reporter after vaccination. It was reported that medical attention was not sought but the patient was scheduled to see her physician on 26-APR-2007. The patient's status at the time of the report was not provided. There was no product quality complaint involved. No further information was provided. No further information is available.
The next day I woke up at 4:30AM I was freezing cold took a shower and was still freezing. Then I took my temperature (100.4 in mouth) and I had a stabbing /throbbing headache. I had every side effect that one could. I was very queasy but never vomited and it lasted all day. Other effects hard to stand up, extremely tired so I slept all day, very crazy body aches all the way to my fingers. Slept most of the day due to being so tired and uncomfortable. Around 8:30AM I took Tylenol, and it did help at all. I felt like I could eat but I didn't. I drank lots of water and Gatorade and one cup of hot tea. Throughout the day my head was still hurting through everything. The headache and the extreme exhaustion lasted the longest. Tylenol 250 milligrams 3x throughout the day, didn't help.
Chills, extreme shaking, temperature of 101.4 at 11:00 pm. Headache  Took ibuprofen 2 different times. Temperature was 99.5 in morning. Still flu like symptoms. Took 2 more ibuprofen.
Reported through internal safety report system, "Patient was given adult Pfizer vaccine instead of pediatric vaccine".
Patient recieved first COVID vaccine dose 2/9 and second dose 3/9/2021.  COVID positive:  9/20/2021 HOSPITAL COURSE:  Patient admitted under observational status for generalized weakness, lethargy, increased confusion and inability to be cared for at home by his spouse.  Patient found to be COVID positive, which would explain his acute  generalized weakness, lethargy and altered mental status.  Patient was not hypoxic thus he was not started on COVID specific treatment.  He did receive monoclonal antibody infusion yesterday.  Patient continues to be weak and lethargic today - not safe to discharge home at this time.  Will be transitioning patient to swing bed here to continue therapy and maintain isolation status.