chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shots gave her typical side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Shots gave her typical side effects) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 969905, 002B21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Ear infection (ear infection once 20 years ago). Concurrent medical conditions included Blood pressure high and Penicillin allergy.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Shots gave her typical side effects). At the time of the report, IMMUNISATION REACTION (Shots gave her typical side effects) outcome was unknown. No concomitant medications were provided.  Patient stated that all of her shots gave her typical side effects.  No treatment medications were reported.   This case was linked to MOD-2022-566651, MOD-2022-566656, MOD-2022-566657 (Patient Link).
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  It was unknown if the doses are first, second or third doses for the patients.The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Pt. c/o of weakness, nausea, and difficulty opening eyes 20 minutes after receiving 1st dose of vaccine. Pt assessed by physician and left sided weakness and decreased sensation in left arm noted. Pt initially answering questions easily but began to have more trouble with responses. Pt. transported to ER by ambulance.
This case was reported by a nurse via call center representative and described the occurrence of lymphadenopathy inguinal in a 19-year-old female patient who received BEXSERO (batch number 158501C, expiry date March 2018). On 21st June 2017, the patient received BEXSERO. On 3rd July 2017, 12 days after receiving BEXSERO, the patient experienced lymphadenopathy inguinal and groin pain. On an unknown date, the outcome of the lymphadenopathy, inguinal and groin pain were unknown. It was unknown if the reporter considered the lymphadenopathy inguinal and groin pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced lymph nodes in groin area after receiving a dose of BEXSERO vaccine in hip area. It felt tender and painful. No additional information provided.
swelling started in 3 hrs 1" high unable to put blouse on arm until 10SEP93; excessive swelling & tenderness;
Felt itchy right after injection. The following day the injection site was hard to touch and swollen to about the size of an eff. Approximately 4 inches long and 1- 1/2 inches wide.
Day 7 BP went to 6/. Treatment 2 bags of fluid (500cc 2x), laid flat, oxygen (2 liters), monitor blood pressure.
6in x 5in red area, warm to touch on Lt. upper thigh.  Slightly raised.  Instructed pt. mother to use cool compress to area/and Tylenol prn.
body itching, eye itching and irritation, body warm, chest tightness, bradycardia
pt returned to clinic w/redness of face & chest, tightness in throat & neck, & a rash beginning on arms;BP was 160/9, P100, R18;
On Sep 25 2018, patient received her first dose of Varicella vaccine. The next day, she developed swelling and redness lesion at injection site.
Patient presented for first dose Pfizer COVID vaccine; vaccine administered at 1315.  At approximately 1330, patient reported 7/10 chest pain associated with shortness of breath, stated symptoms unlike previous chest pain episodes. Patient transported from vaccine clinic to private room via wheelchair, EMS called at 1335. Upon EMS arrival at 1342, patient reported chest pain had decreased to 1/10, still reported shortness of breath. Patient transferred from wheelchair to EMS stretcher, transferred to ED via EMS.
Patient presented to clinic on 09/21/23 stating her left arm was erythematous, edematous, tender, and hot to touch beginning the night of 09/20/23.  Patient presented pictures of how the injection site looked initial to how it progressed. Patient reports use of Tylenol with no relief. Patient was referred to higher level of care due to the rapid progression of swelling at the injection site.
On March 25, 2019 I got my first shingles shot. It is the most painful injection I have ever had. Other than hurting for two days I did not have any other reactions to it. On June 5, 2019 I returned for the second injection in the series. It hurt just as bad. Day one it was sore but only had a small red spot at the site probably 1 1/2 -2 inches in diameter. Day 2 at about 12:30 I met my husband for lunch I was unable to eat because I had a headache. When I stood up my legs had pains (muscle/joint) it was a little difficult to commence walking. When I got home I went straight to bed. I got chills, a high fever 102.5, profuse sweating and a headache. I took several doses of Tylenol & Aleve through the night. Day 3 Friday June 7, I no longer had the chills but continued with low grade fevers & feeling bad. The redness at the injection site got bigger, redder & hot. It was about 4 inches all the way around. One large circle. I may have slept 30 minutes at the most. I had leg muscle and joint pains throughout the night. On Day 4 Saturday June 8 I returned to pharmacy to have the pharmacist take a look at it. She hesitantly advised that I may be able to wait a day. She cleaned it up with alcohol swabs & covered it with a bandaid. At that point I decided I better go to the Urgent Care Clinic. Because today the injection site was even redder, more swollen & more inflamed and hot. While I waiting to be seen the pharmacist called. She had done some research & felt I sho see I went to urgent care and was seen by Dr. His diagnosis is I have staph/cellulitis of my left arm on injection site. His prescriptions were doxcycline hyclate 100 mg & mupirocin cream. He administered an injection of cetriaxone sodium per. Day 5 Sunday June 9, still red & swollen but slowly getting better. Day 6 - Monday June 10 still recovering the site slowly fading
Preeclampsia and BP was high. 4 weeks after your 2nd dose. I got induced on 6/1/2021 and delivery early on 6/2/2021 and went back to the ER was on 6Jun2021. Had high BP on 31 May 2021. Baby - born 6/2/2021 and she 6 pounds 13 ounces.
Client contacted health department to report extreme pain in (L) upper extremity with numbness; client also states that she had "passed out" secondary to extreme pain. Client had received PNEUMOVAX vaccine 10/14/08. Client was instructed and present to the medical clinic to be observed by her primary care provider. Client called HD @ 8:30 AM. Client was scheduled in clinic @ 8:45.
I felt it important to report that I experienced a deep Fatigue 2 weeks after receiving the 2nd shot of the Pfizer vaccine. It has lasted for 2-3 weeks.  A deep fatigue - where I slept long hours 16-18  hours over  2-3 days and after that a period of feeling of listlessness. It is now 2.5 weeks after experiencing the deep fatigue, and I am now beginning to feel more like "myself".
severe/painful distal extremity burning sensation and feeling off balance while walking, started within 1 week of getting 2nd dose. Symptoms slowly progressed more proximally in extremities over the following 3 months. Admitted to the Hospital where workup showed inflammatory demyelinating polyneuropathy (unclear if acute or chronic based on timecourse)
no adverse effect; Improperly stored vaccine administered; This spontaneous report as received from a medical assistant (also reported as nurse) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 20-DEC-2019, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S001338, expiry date : 14-JAN-2021) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of above 47 degrees Fahrenheit / 9 degrees Celsius (55.44 degrees Fahrenheit) for a duration of 5 hours (product storage error). There was no previous temperature excursion. It was reported that this call was due to  a digital data logger.  The patient had no adverse event. There was no product quality complaint involved.
psoriasiform eruption at lower buttock and inner thighs- never with similar rash in past. raised, red, serpiginous + annular lesions with silvery/white, rough scale at surface.
Vertigo, dizziness, nausea, vomiting that came on suddenly at 6am while sleeping. Never been treated for vertigo in the past. Never had vertigo in the past. Went to the ER and was given zofran and meclizine. Symptoms got better but are not gone 2 days later. Vertigo is still very bad.
7 days post vaccination of Varicella & MMR (separate inj) on the right leg. Child presents with fever, redness & swelling at the inj site, and a rash.
On 5 MAR 21, I was driving home from PT, and broke out in itchy welts on my face, particularly the right side, the right side of my throat, and right side of my face swelled up over the next hour.  Over the next month, I noticed I was short of breath and my heart rate was going up very quickly with intense cardio, which I do regularly.
Redness at injection site 35mm in size.  Red, flat areas on chest 10-14mm in size, pain at injection site, no itching.
Boostrix administered to patient 10 days past its expiration date; This case was reported by a other health professional and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The Boostrix was administered to a patient 10 days past its expiration date, which led to expired vaccine used. The reporter ask was the dose still viable.
Information has been received from a consumer concerning her daughter who on approximately 06-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced diarrhea and vomiting. The outcome of the patient was unknown. The patient did not seek medical attention. Additional information has been requested.
7:00PM (9 hours after shot) -Ringing in Ears -Muffled Hearing -Ear Pain/Ache (Dr. Recommended taking a decongestant) This did not help the situation and this symptom is still occurring as of 9/21/21. 7:00PM (9 hour after shot) -Extreme nausea -Severe Headache (Dr. Recommended taking Tylenol for this during appointment--Tylenol did not greatly help headache) Saturday 9/11 at 9:00AM (All other symptoms persisted along with....) -Blurry Vision -Unable to regulate temperature. Very hot/very cold---did not have a temperature.  Sunday 9/12 (All other symptoms persisted along with...) -Spontaneous unexplained bruises over night. Appeared on thighs, 9 large bruises the size of a quarter or larger. (Did not participate in any activity that would explain bruises) -Dr. Ordered a Complete Blood Panel. Numbers came back "ok". Will be asking for another test in a few weeks to confirm numbers are "ok". Tuesday-Wednesday 9/14-9/15 (All other symptoms with the exception of blurry vision persisted along with...) -More bruises appeared on the back of right upper arm, lower right leg near ankle, calf of left leg -Injection Arm Pain and Weakness (from elbow to shoulder)
Oculorespiratory syndrome- conjunctivitis in both eyes, eyes swollen and red, cough, feeling like something in throat, chest tightness lasted about 6 hours
4 days after the vaccine I started my period.  light spotting and cramps 6 weeks after the vaccine I woke up with a typical burst blood vessel in my right eye.   I realized my actual eye color changed from hazel to blue.  As silly as this sounds the color change is not the typical "I was wearing blue, so my eyes looked blue"   It changed from hazel to blue overnight.  The blood vessel healed, the eye color change has remained.  Its pretty but a little strange. It is over 3 weeks.
7OCT91 admitted to hosp w/arm pain, chest pain, equilibrium problems & vomiting; pt states involved 8th cranial nerve w/neuralgia;
Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Additional Details: Pt fainted from seated position and hit the floor face first.  He was responsive and able to roll onto back and rest for several minutes before sitting up. Emergency services arrived and took vitals.  He almost fainted again and so was taken to hospital but not admitted. He has since recovered.  Pt states he was most likely dehydrated before the vaccination.
Patient developed poor color tone immediately following DTap, IPV, Hib, Prevenar immunization. P, RR, Pulse ox NL. Although still subdued. Patient recovered within several mins, slept for several hours, and then was back to normal.
Initial information has been received from registered nurse concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions / allergies. On 12-JAN-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route were not reported). On 31-MAY-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route were not reported). On 09-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Had seizure. Fell in shower, started shaking uncontrollably, had difficulty breathing. He had a seizure for the first time in his life 6 days after first dose (already reported). This one was his second seizure ever.
All over body itching almost immediately after intradermal flu vaccine. Rash on & off ever since - 5 days ago.
5 days post 2nd Moderna Covid 19 vaccination. I had multiple episodes of Bradycardia with Bigeminy. Heart rate to 37-40. Ended up in Ed on April 8,  and cardiologist office on April 9th , there noted to have Bradycardia and Bigeminy.  Early Am on April 10th had Atrial Fibrillation.
Pt stated 2 days after administration injection site became swollen, red, & itchy.
Swelling/redness at sight of injection of MMR (right arm).  Hives right side of body.  Headache, low grade fever.
24 hours after immunizations mother noted child's arm (left) was swollen from elbow to shoulder was warm and reddened and hard.  She was instructed to use ice therapy for swelling.  NO fever noted.  Child continue to play without complaints.
I received my 2nd Pfizer vaccine on the 9th, started with fever, chills, body aches, and headache about 12 hours later and then woke up Sunday morning with abdominal pain and nausea. The pain got worse throughout the day so I went to the ER Sunday afternoon and a CT revealed acute appendicitis. I was admitted to the hospital Sunday and had a laparoscopic appendectomy Monday night.
Patient came to the ED with dizzyness and falls.  Patient was found to have Covid, dehydration, ARF, and hypokalemia and was admitted to the hosptial.
developed sx including low grade temp, nasal drainage, congestion and tested positive for covid 1/13/2022. Tested on binax rapid antigen. She is fully vaccinated and boosted for covid- booster dose information listed above. Had potential exposure from another resident on unit who tested positive earlier in the week.
antibody deficiency which is an IGM deficiency; has to get her walker to get up; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (17Aug2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot: EN6280), administration date: 20Feb2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "allergic reaction with swelling in the throat", "allergic reaction with swelling in the throat", "very dizzy and lightheaded", "some tightness in her chest"; BNT162b2 (Dose 2, single, Lot: EW0150), administration date: 07Apr2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "1st dose was administered on 20Feb2021 / 2nd dose administered on 07Apr2021"; BNT162b2 (Dose 3, single, Lot: PFMPC0FD8448), administration date: 07Sep2021, when the patient was 77-year-old, for COVID-19 Immunization. The following information was reported: SELECTIVE IGM IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "antibody deficiency which is an IGM deficiency"; DYSSTASIA (non-serious), outcome "unknown", described as "has to get her walker to get up". The event "antibody deficiency which is an igm deficiency" required physician office visit. Therapeutic measures were taken as a result of selective igm immunodeficiency.  Clinical course details: The patient height is 5 feet tall and shrinking. The patient was treated with oncologist for her antibody deficiency which is an IGM deficiency with immunoglobulins. States the doctors office said she had a 5th dose also but she does not have the date, lot number for that to provide as she does not have a patient card for that dose. Caller asked Whenther it's booster shot that may coming out because she doesn't want to have any adverse reactions. What she guesses she wants to know is what they are thinking on this new vaccine and do they think there will be an adverse effect or adverse effects with it as she is scared to go ahead and get it if there are any adverse effects as she has less people helping at her house now.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278841 Same patient, different vaccine dose/event;
I started getting bruising throughout my body and when have a CBC blood count platlets had dropped to 2,000. I had seen my primary care before the flu shot and my platlet count was normal.
Not sure if this information is needed but for the record: I have been getting light head aches in the center lower back portion. description of pain  is sharp but not long lasting. The head aches happen at least three times a week.
numbness and discoloration of arm Narrative:  Patient reported "numbness and discoloration" on left arm from tip of elbow toward arm pit approximately 3-4" length x 2" wide started 3/13/21-2 days after receiving vaccine-has not worsened or improved. Patient states that the affected area is "brown" in color slightly darker than his skin
Right arm- hurt and child resistant to move. Redness and swelling noted. C/O pain over deltoid area. Applied ice and gave Tylenol 3/1/04. Dr.  "muscle injury" Aleve rx + rest.
-he came to the hospital with a chief complaint of worsening cough and altered mental status has reported by than memory care unit staff.  History not obtained from the patient due to advanced dementia.  Daughter present at the bedside provided the history.  She reported that apart from altered mental status agitation and worsening cough with yellow color expectoration the patient does not have any other symptoms like fevers, chills, abdominal pain, nausea, vomiting, chest pain, shortness of breath, palpitations, burning or painful urination, diarrhea.     01/03/2022 tested positive
Pt was admitted to hospital for febrile seizures. During this time was when the doctor found she had a needle abscess of the left upper lateral thigh & wanted to know which vaccine the pt was given. The Dr. stated the vial of vaccine may have been contaminated.
swollen upper lip/ Top lip is swollen; swollen mouth/ Mouth is Swollen; body ache; stuffy nose/Nose is stopped up like he has a cold; fever; head ache; This is a spontaneous report from a contactable consumer or other non hcp.  A 15-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3180), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 15:15 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. It was Reported that, the patient experienced swollen upper lip/ top lip is swollen serious, swollen mouth/ mouth is swollen, body ache, stuffy nose/nose is stopped up like he has a cold on 17Aug2021 with outcome of not recovered, headache on 16Aug2021 with outcome of not recovered, fever on 16Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of swollen upper lip/ top lip is swollen (lip swelling), swollen mouth/ mouth is swollen (mouth swelling), headache (headache), body ache (pain), stuffy nose/nose is stopped up like he has a cold (nasal congestion), fever (pyrexia).   Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Case number PHEH2014US022305, is an initial spontaneous report from a pharmacist received on 04 Nov 2014. This report refers to a 13-year-old female patient. Medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 011021A) intramuscularly at a dose of 0.5 ml on 01 Nov 2014. No adverse event was reported following this medication error.
Around 2am I work up with chills, fatigue, nausea, headache and muscle and bone pains.  The chills, headache and nausea lasted about 36 hours.  I may have been running a fever but I never dug out a thermometer to check.  The muscle and bone pains were so bad I had to take pain medicine (and I usually have a high tolerance for pain and I was trying to avoid any pain medications to not interfere with my immune systems response to the vaccine).  The pain lasted about 48 hours.  I had the shot on a Wednesday.  All I did on Thursday was rest and sleep, I couldn't really move around because of the pain and fatigue.  I also didn't have much of an appetite.  On Friday I felt a little bit better and by Saturday I felt much more like myself.  On Friday my arm below my injection site started to hurt.  It was red and swollen with a fever in it.  Right now (Sunday) the red, swollen area is about six inches long and three inches wide, still really swollen, hot and painful. If my arm doesn't get better in a reasonable amount of time I'll report back.  Or if it gets worse I'll go to my doctor.