chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117/expiration date 06-NOV-2018, lot # M032649/expiration date 11-NOV-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.4 degrees Fahrenheit) and 32 degrees Fahrenheit to 35 degrees Fahrenheit for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012213: US-009507513-1708USA012214.
Patient presented to ED with weakness and shaking at 10pm. Temperature 100.5 F. Denies SOB, cough, diarrhea. Mild crackles at LLL. CXR shows atelactasis vs. mild pneumonia. Started on Omnicef and Liquibid. Admitted to hospital for observation. on 10/9/03 pt was to be discharged, progress notes state reason for admission was immunologic reaction to flu vaccine. While preparing patient for discharge, she become hypoxic with a PO2 of 56. Discharge canceled and patient placed on O2, Rocephin and Zithromax.  CT of thorax to rule out PE was negative. Pt. discharged 48 hours later with no further problems. The discharge summary states viral syndrome, and imunologic reaction flu.
swelling of ankles and feet;  Difficulty breathing , Lethargic.  has continued 3 weeks after 2nd shot.
Hip Ache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Hip Ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRALGIA (Hip Ache). At the time of the report, ARTHRALGIA (Hip Ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt came back 1/18/13 to report by 6 pm could not breathe / dizziness / rash on (R) arm & leg (not at injection site), pain in chest last night. Pt felt better today (3pm today).
vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications details were reported by the reporter.  Patient weight was reported as 211.6.  On 10-Jun-2022 vial was initially stored in the refrigerator and vaccine was administered on 12-Jul-2022 (30 day beyond use date). No temperature excursions was reported. No Adverse reaction was reported.  No treatment details were reported by the reporter.
This is a spontaneous report from a contactable other healthcare professional (patient). A 31-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 12Jan2021 at 13:30 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no known allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 23Dec2020 at 03:00PM. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced hives on 15Jan2021 at 16:00. Treatment for the event included Corticosteroid, h1 and h2 blocker. The event resulted in Emergency room/department or urgent care. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The event had not resolved.  Information on the lot/batch number has been requested.
Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, symptoms resolved quickly.
I just feel itchy, very itchy for no reason; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose number unknown (booster), single (Lot number: GJ5342, Expiration Date: 17Nov2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Oct2022, outcome "unknown", described as "I just feel itchy, very itchy for no reason". No follow-up attempts are possible. No further information is expected.
No symptons,or signs prior to child not breathing. Child taken to ER and CPR was implemented.
Within minutes of receiving the first dose of the vaccine, my tongue became itchy. As the evening went on, my neck became sore. I took an antihistamine that evening when I got home. The itchy tongue continued for approx 10 days, following the injection.
increased GI issue; joint inflammation; Sinus issue; weakness in arms and legs; heart palpitations; Migraine; lightheadedness; fatigue; burning at injection site; muscle cramping/soreness/weakness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8734) in the arm left on 09Apr2021 at 13:00(at the age of 31-year-old) as a dose for COVID-19 immunisation. Medical history included mast cell activation syndrome. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 13:00 the patient experienced weakness in arms, heart palpitation, migraine, light headeness, fatigue and burning at injection site. On 10Apr2021 the patient experienced increased GI and sinus issues and joint inflammation. The patient reported after 5 - 15 minutes of injection: burning at injection site, weakness in arms, heart palpitations. 1 - 2 hours after injection: weakness in arms and legs, heart palpitations, migraine, lightheadedness, fatigue. 5 hours after injection: immense fatigue, muscle cramping/soreness/weakness. Next day (10Apr2021) : increased GI and sinus issues, immense fatigue, muscle weakness, joint inflammation, migraine, lightheadedness. Next 5 days: fatigue and muscle weakness continued. The clinical outcome of the event weakness in arms, heart palpitation, migraine, lightheadedness, burning at injection site increased GI and sinus issues, fatigue and joint inflammation were recovered.  No follow-up attempts are needed. No further information is expected.
SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Plaque psoriasis.    No Medical History information was reported.   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced CONDITION AGGRAVATED (SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT). In 2021, CONDITION AGGRAVATED (SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT) had resolved.            Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   The reporter's causality for the event(s) of small flare up on both elbows, more on the left with Humira was not provided.   Reporter did not allow further contact
shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/ or administered by a healthcare provider at veterans clinic, for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Apr-6--mild thalamic stroke confirmed by MRI and neurology consult. Apr-15, 16, and 23 -- unknown but same symptoms as thalamic stroke,  CT CAT scan scheduled for Apr-26.
10/21 - Happy then sudden, inconsolable, and persistent crying for no apparent reason for 1 hour in the afternoon which is unlike his normal, calm behavior. When he does cry, it is for very short periods and can be easily consoled. Long nap this day (2.5-3 hours).  10/23 - Repeat of 10/21, except in the evening. Happy, then in consolable crying during dinner. Put in a time out for 3 minutes at an attempt to console crying. Normally, he will stop crying within 1 minute during time out. Cried for full 3 minutes until I finally went to him to console him. Very unlike usual behavior. Also took 3-hour nap earlier today. Normal is 1.5-2 hours.
2 hours after receiving the Pneumococcal vaccine I had (extreme) pain 10 of 10 and could not use my Left arm. 4 days before I could take off shirt over my head and another 10 days before mostly full use
Information has been received from a 78 year old female consumer with no known allergies or medical history who on 09 Oct 2006 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. Subsequently two weeks after vaccination on approximately 23 Oct 2006, the patient developed shingles. As of 06 Dec 2006 the patient's shingles persisted. Unspecified medical attention was sought. There was no  product quality compliant involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007. Additional information from the physician indicated that the patient broke out with shingles on 10-Nov-2006. The patient subsequently recovered in November 2006. No additional information is expected.
Rash appeared in both elbows creases and lower legs. Patient applied hydrocortisone which she states helped. Advised patient to follow-up with primary care doctor.
i slowly developed muscle weakness and swelling in my hands muscle weakness from my knees up to my shoulders
Pt received Flu shot on Wednesday (11/1/2017) and by Friday she reports having chills, heavy eyelids, hives symmetrically of the lower body, "felt like a truck hit her" . Patient reports symptoms remaining severe for 3 days (Friday-Sunday), but by Monday started to feel better and improved somewhat every day until the symptoms subsided when she contacted the pharmacy on 11/10/17.
Patient attended clinic to receive second dose COVID-19 vaccination requesting Moderna. RN administered second dose Moderna and discovered patient had received first dose Pfizer COVID-19 vaccination afterwards.
UNEXPECTED EFFECT WAS THE FEELING OF FADING MOSTLY WHEN STANDING. MY BLOOD PRESSURE WAS TAKEN AND I REVEAL 100/50. I AM A HYPERTENSIVE PATIENT. THE OTHER EFFECTS WERE CHILLY, NIGHT AND DAY, NAUSEA, AND STRONG ABDOMINAL PAIN.
as soon as i received the vaccine i had really bad arm pain then a tightness across my chest but was not heart related felt like the pain in my arm more muscle.  this lasted about 8 days. a few hours after getting the vaccine I  got a bad headache. I normally do not get headaches.  I have had a headache nearly every day since. I have taken tylenol and when sever a NSAID but I'm not suppose to take NSAIDS due to having a lapband. I wake up with them and go to bed with a headache. a few days it seems like they have stopped but then they come back. I get fatigued easy the next day after the shot it was a struggle to do normal things i just wanted to lie down. I did not feel sick just exhausted. this comes and goes exercise really wipes me out just normal walking afterwards i will want to go to sleep . I feel like i have to keep apologizing when i cant help with things and say give me a minute.
Developed pruritic rash to bilateral hands and arms over 24 hours following vaccination No systemic symptoms, involvement of mucous membranes, vesicles, or pustules Rash worse on R side; patient was vaccinated on L side No history of reaction to vaccines including 2-dose primary series of Pfizer Comirnaty
Left upper arm swollen, painful and itching. Induration of skin. 1.75 in red indurated and raised. Elocon 0.1% cream given to apply to affected area, hydroxyzine 10mg/5ml given for itching prn. Shot of DECADRON/DEPO MEDROL given.
Trouble breathing, no appetite, fevers spiking up/down to 103. Since was dehydrated took to ER on tue 10/9, admitted to hospital.
The first shot I got in April gave me fever all night but I was Ok in the morning. The second shot was much worse, as the fever subsided by 9 am or so but I felt like I had the flu for the next two days. I'm still in day 2. Nausea, headache that aspirin didn't affect, muscle aches. I am a very healthy person, nothing much affects me, but this was a much stronger effect than any of the literature on SHINGRIX suggests. Am wondering if the second dose is stronger or generally produces greater side effects.  Maybe this is silly to report, but if I had this much problem, I am sure others will.
Fever, treated with Tylenol every 6 hours Nausea Body aches Chills  All still ongoing
No ADR Patient was supposed to be receiving the first primary dose but inadvertently received the Pfizer bivalent which is only indicated for booster doses.
Approximately ten days after the second shot of the vaccine I began menstruating off-cycle with a very heavy flow and strong cramping that last about 7 days. During my regular cycle window I experienced another heavy period. The following month (May 2021) I did not have a period, and did not have a period again until August 14, 2021. On this date I passed a pea sized clot and experienced heavy flow and cramping. This was during my expected cycle window. Typically, my cycles are extremely light and last 1-2 days with no cramping.
Break through chicken pox; Less than 10 pox on trunk; Did not require medical attention; No temperature; No discomfort.
Vaccines given to pt in our office 01/12/04.  Pediarix right thigh, HIB and Prevnar Left thigh.  Pt reported a SC nodule on right thigh 3/4cm x 1.5cm today 01/28/04 and was evaluated in our office same day.
Arthralgia fatigue, lymph node swelling in injection side neck and jaw , ear pain Narrative:   Other Relevant History:
Pt complained numbness/swelling in tongue.  I gave her 2 diphenhydramine 25 mg immediately. Observed her for total of up to 24 minutes. All this time she was not having and chocking/closing of throat. She could talk fine and awake and alert, pt's husband was with her. I called her PCP and informed them about having this reaction and got EpiPen RX for her and dispensed her to take it home. I walked through with her on how to use it and instructed to call 911 if any emergency situation and any time she feels she cant breath. She was in the pharmacy under observation for about an hour and then she left with her husband with EpiPen to go home. I called her again around 4:30 pm to check on her. She was feeling ok
headache @1:30pm  pain  left arm @ 8pm body aches9:20pm nausea10pm an urgency to move bowels 10:30pm ( relieved after bowel movement @7am) chills10:30pm  sweating10:30p loss of strength/ lack of energy/ weak 11pm  muscle aches 11pm slight confusion 1:30am joint (wrists and ankle) 7am all previous symptoms exists into next day 3/18 except the confusion  motion appears to relieve the body aches
1. Unusual Missed Menstrual Period after vaccine (It was 44 days between the cycle before vaccination to the cycle after vaccination)  2. Pain extended from my arm (at injection site) across my chest for 24 hours the day after injection.
1hr p/vax pt devel redness @ the inj site, swelling @ the inj site which extended to the elbow, stiffness w/an inability to lift arm, & vomiting;
onset 29JUN of hives & tenderness @ inj site & fever 101.9;RD nickel sized bumpy red spot, sl faded by 30JUN;LD nickel size 29JUN-quarter size 30JUN, bumpy irregular shape;pt cranky teething;DPH w/o relief;
2 maculopapular lesions to the lateral aspect of left thigh without erythema or warmth. Slight induration. Non-infected localized reaction. Tx: warm compresses.
Information was received from a nurse via a company representative referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions were not reported. On an unknown date, the patient was administered a second dose of PNEUMOVAX 23 (strength, dose, lot# expiration date and route unknown) 2-3 years after the first dose (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
The rash on my leg/I developed a rash; bad side effect of the Moderna Shot afterwards; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (bad side effect of the Moderna Shot afterwards) and RASH (The rash on my leg/I developed a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Edema and Overweight. Concurrent medical conditions included Allergy (allergic to lysol laundry additive).    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (bad side effect of the Moderna Shot afterwards). In August 2021, the patient experienced RASH (The rash on my leg/I developed a rash). At the time of the report, VACCINATION COMPLICATION (bad side effect of the Moderna Shot afterwards) outcome was unknown and RASH (The rash on my leg/I developed a rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  It was reported that patient was overweight, had edema and lost 75 pounds. Patient was allergic to things and got this rash and it will not go away. She was about 95 percent better though with the rash.  It was also reported that  she does not take other medications and  reported no further lifestyle changes or medical history.
Arm/shoulder pain, radiating down arm and numbness, tingling and weakness in left arm
Brain fog, confusion, dizzines, light fever, ear pain. Probably acelerated heart beat as my father described, nausea.
Fever up to 101.5, chills, fatigue, body aches and joint pain
Patient had fever the day following vacination, he also was uncoordinated and weak. He had a temp of up to 104.1 - 104.4 on and off until 8-21-04. Tylenol was given per his body weight but temp didn't completely go away and spiked again 3 or so hours after administration. 8-20-04 patient was extremely weak and slept most of the day. He was moaning and very incomfortable. He was only comforted to sleep laying on my, his mother's, chest. I am very worried that long term neurological problems have begun here. He was given DTaP along with 3 others. According to the vaccination form, he was not supposed to receive the DTaP until 15- 18 months.
Patient was observed for 15 minutes following vaccination and then left the pharmacy feeling fine.  Patient returned to the pharmacy about 45 minutes later reporting throat tightness and tingling in the face.  Pt reported symptoms seemed to be getting worse.  911 was called and paramedics arrived to the pharmacy.  Pt was evaluated and given the option of going to the hospital for further monitoring but declined.  Pt purchased Benadryl and was instructed by EMTs to call 911 if symptoms changed/worsened.
RASH ON FEET AND HANDS, WENT TO URGERNT CARE AND THEY DIDN'T DO ANYTHING.  HAND TREMORS, HAVING A HARD TIME DOING MY WORK WITHOUT MY HANDS SHAKING.
5/23/05 Child woke up with few varicella lesions. Seen by this office for confirmation of diagnosis. 5/24/05. Child had 15+ lesions papular in nature over body. Diagnosed as chicken pox.