chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received booster that looked brown) and PRODUCT COLOUR ISSUE (Received booster that looked brown) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 23-Nov-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received booster that looked brown) and PRODUCT COLOUR ISSUE (Received booster that looked brown). On 23-Nov-2021, POOR QUALITY PRODUCT ADMINISTERED (Received booster that looked brown) and PRODUCT COLOUR ISSUE (Received booster that looked brown) had resolved. Patient do not have any adverse event related to vaccine. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Follow-up received include reporter and patient details, information about product and concomitant medication and narrative updated.
Pt received an H1N1 flu injection in L arm, then seated himself in the observation area.  He says he felt a little ill, so he stood up.  He became pale and diaphoretic, so he sat down.  He was then placed in trendelenburg position on a floor mat, with ice pack on post neck.  His BP was 110/70 and pulse 100.  When color improved he was sent via wheelchair to nurses clinic to recover.  His father was notified.
A 48 year old female report that she received a dose of Flumist and on 12/10/03, experienced a severe bloody nose. On 12/10/03, the reporter experienced a severe bloody nose, after receiving a dose of Flumist. No additional info was available at the time of this report.
Patient was administered the Merck HPV vaccine - third dose, patient reported left hand tingling. Physician evaluated - patient returned home.  Physician called patient at home at 3:00pm - patient reported that tingling is resolved
Case number PHEH2014US004274 is an initial spontaneous report received from a pharmacist on 27 FEB 2014. This report refers to a 12-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 02 JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 27 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administration to child".
Extremely tired  Lack of energy  Just Walking across the floor seems like it takes forever  I noticed my gait is even more stiff... I feel like I?m 200 years old  I can?t do activities for very long  until I have to lay down  I feel I can?t clear my mind  Not able to process things as I used to do so I get very little done or accomplished  In the morning my head hurts I feel like I have a hang over all the time
ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 SUPERVISION HIGH RISK PREGNANCY, HX OF CESAREAN SECTION, SECOND TRIMESTER ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 CESAREAN DELIVERY ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 PREECLAMPSIA, UNSPECIFIED, IN CHILDBIRTH ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 ILEUS ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 SMALL BOWEL OBSTRUCTION
Received flu shot 11/17/06 in office-started within 20 min. Elbow down to 1st and 2nd fingers. Pain and very weak "could still bend fingertips, couldn't lift a plate)". No numbness. Self limiting resolved in 15 minutes-held arm above heart and kept moving.
shortness of breath.  Cough and chest twinge-like pain  Covid test came back positive.  Patient's chest x-ray showed no evidence of pneumonia.  Her troponin was elevated at 0.53 and repeat was elevated at 0.64 and she was started on heparin drip.  150 mg of amiodarone over 10 minutes.
Received shot on 3/12.   Starting having pain in chest on 3/22.   Was diagnosed with blood clots in the lungs on 3/26 via blood test and CT scan.
Received both shots at doctor's appointment around 9am. I drove to work and approximately around 11:25am I started to feel a little sick (needed to vomit or was getting vertigo/dizziness). I was conscious for a couple more minutes and then my co-workers said I started to collapse, and they called EMS.  They said I had jerky movements of my hands and was sweating (they thought I was having heat exhaustion due to the cleanroom gowning I had on). They said I turn dark red, then blue/purple and then very pale. I was having trouble breathing until they tried chest compressions and then I started breathing again regularly. I was foaming slightly at the mouth and had bouts of lucid talking (somewhat incoherent). Within a short while, the ambulance showed up and I regained full consciousness for the rest of the day. I could only recall up to the point just before passing out and just as they were loading the gurney into the ambulance.
Rash on arms, legs, cheeks/face. Morbilliform rash and fever. Immunization administered on 2/5/2016. MMR. Maculopapular eruption with fever. Temperature 102.1 (F).
Received flu shot 10/19/19 and symptoms of CIDP started November 6th 2019.
Eye fatigue, eye dryness, eye soreness, eyelid swelling -  ongoing  Migraine - intense pain for 24 hours, still tension with some improvement ongoing
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 18:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: the patient was given Paxlovid from 22Jul2023 to 27Jul2023 for the treatment of Covid-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
report of feeling of impending doom, flushing, weakness, tachycardia, and shortness of breath
the patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non healthcare professional via Agency (reference number- 00543062) and transmitted to Sanofi on 31-Mar-2021.  This case involves an 18 year old male patient who was administered an expired 0.5ml dose of suspect IPV (VERO) [IPOL] (lot number: R1B251M and expiry date: 13-Mar-2021) via subcutaneous route in the right arm for prophylactic vaccination on 23-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (lot number and expiry date: not reported), HEPATITIS B VACCINE (lot number and expiry date: not reported) and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TETANUS DIPHTHERIA) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated that IPOL expired on 13-Mar-2021 and administered to the patient on 23-Mar-2021. The reporter wanted to knowif there was a grace period.  At the time of this 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.
Pain, swelling, rash at injection area.  The area is tight and warm. Still swollen as of Monday 2/15.
neck and under the arm lymph nodes got swelled up/swelling was worse causing left side inflammation; Swelling was worse causing left side inflammation; Chest pain; Chills; Sweating; Pain in chest due to lymph nodes was very hard and also under the armpit.; This is a spontaneous report from a contactable other health care professional (Patient). A 34-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206, Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 01May2021 13:15 (at the age of 34-year-old), as single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number: EN6206, Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 01May2021 13:15 in Left Arm as a single dose for COVID-19 immunization. The patient medical history was reported as none. The patient does not have known allergies. The patient concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021 after second dose, the patient experienced swelling was worse causing left side inflammation, chest pain, chills, sweating, pain in chest due to lymph nodes was very hard and also under the armpit. The events resulted in visit to physician or other health professional office. The seriousness of the events was reported as non-serious. Therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events was resolving. The device date was reported as 04May2021.  No follow-up attempts are needed. No further information is expected.
Pain and blotchy redness around injection site, progressing to muscle aches and pains involving shoulder and pelvic girdle and Achilles tendon, headache, flu like symptoms, and taste perversion. Low-grade fever and chills. Self treated with OTC ibuprofen every six hours.  Symptoms gradually resolved over the course of 02/13/2019.
JOHNSON & JOHNSON MILD SIDE EFFECTS; 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 johnson & johnson mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of johnson & johnson mild side effects was not reported. This report was non-serious.
After the shot I had a high fever, chills, and massive sweating, fatigue within the first 48 hours. 72 hours later I felt better, then I began having pain in my heart. The pain is sudden and sharp, the lasted 2 hours on the third night. I was just doing my nightly routine of cooking dinner and getting the kids ready for bed after I took them to the park. The pain came back the next day(yesterday) in and out at night time when I came back to the house stressed out because we were late coming home from the park. Now being the 5th day after the shot, it is daytime and when I get super stressed I can feel the tightness in my heart not in a super painful way but enough to know it is there.  After my first shot, I felt nausea the first three days, and on the fourth day I felt the same pain in my heart for 4 hours straight during the night, then it went away and never returned.
My husband and I had Moderna shot yesterday can he get tested for Covid if it's his first shot? He's been very sick Can he get a Covid test right after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (My husband and I had Moderna shot yesterday can he get tested for Covid if it's his first shot? He's been very sick Can he get a Covid test right after the vaccine) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (My husband and I had Moderna shot yesterday can he get tested for Covid if it's his first shot? He's been very sick Can he get a Covid test right after the vaccine). At the time of the report, ILLNESS (My husband and I had Moderna shot yesterday can he get tested for Covid if it's his first shot? He's been very sick Can he get a Covid test right after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Received flu vaccine approximately 845. My arm began to feel heavy. Within a few hours I developed a headache. The next day arm swollen from elbow up to neck on side vaccine administered. Congestion, warmth at site continue swelling decreasing.
pain around her heart; shortness of breath; This is a spontaneous report received from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain around her heart and shortness of breath on an unspecified date. Outcome of the events was unknown. PQC Details: Product: Pfizer-Biontech Covid-19 Vaccine. Question: Does the Pfizer BioNTech Covid 19 vaccine cause any heart issues? Response: spoke as per doc attached and referred back to HCP. Product: Pfizer-Biontech Covid-19 Vaccine, Question: Transfer from Agent in DSU NTID CHILDA09 REP: 0L7OP1U2 (duplicate AE etransmitted incase additional information was conveyed during call. Caller, female, aged 75, received both doses of the Pfizer BioNTech Covid 19 vaccine on 13Feb2021 and 6Mar2021. She is still experiencing shortness of breath and pain around her heart. She is concerned after hearing that the creator of the original mRNA vaccine is no longer involved with making the vaccines and has warned not to give the vaccine to children under the age of 12 for at least two years, and that the mRNA technology is not working the way he had initially thought it would. She wants to know if there are any known fertility issues with the vaccine? She has several nieces and nephews as well as a grandson who are in their childbearing years. Response: spoke as per Infertility CONS attached and referred back to HCP.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Uncontrollable shaking, high fever with sweats, nausea for three days after the shot. Extreme fatigue.
1) Flushed (hot) feeling in face 2) Chills in other body areas 3) Sore/aches in neck, shoulders, and arm
Hospitalization for shortness of breath due to COVID-19 on dates 7/29/2022-7/31/2022 .  Treated with  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
She came to the hospital 2/12/22 with a chief complaint of near syncope yesterday.  She complains of fevers and chills and generalized body aches with mild dry cough.  All these symptoms as starting since yesterday as well.  She has not been taking her Plavix and Xarelto for last 2 days as she had to be scheduled for port placement for chemotherapy for breast cancer.  She denies any chest pain or shortness of breathbut did have some palpitations.  Denies any abdominal pain, nausea, vomiting, burning or painful urination, diarrhea.  Previously vaccinated Moderna 4/5/21, 5/3/21, 9/8/21.  Discharged 2/15/22
Upper anterior chest discomfort, uncomfortable breathing, teeth hurt, bilateral knee joint pain, started  day five and continue . severe headache one night only on evening of day 5.
Information has been received from a licensed practical nurse (LPN) concerning a 59 yr old female with no medical history and no known allergies who on 10Nov05 was vaccinated IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). There was no concomitant medication. Subsequently, the pt developed red, hot, painful and grapefruit size areas at the injection site. On 14Nov05, the pt was seen in the office and was treated with compresses. The pt was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
first dose over 2 years ago, did not get 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis..   Previously administered products included Shingles vaccine (received 1st dose over 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked for recommendation. The follow up would not be possible as no contact details were provided.
severe allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "severe allergic reaction". Therapeutic measures were taken as a result of hypersensitivity. Mother mentioned that she spoke with his son's HCP who was unable to determine if the reaction was due to the vaccine. He was given Benadryl and advised to take Tylenol if needed.  This follow-up is being submitted to notify that the lot/batch number is not available despite the fol-low-up attempts made. Follow-up attempts completed. No further information is expected.
1/23/21 First shot: sore arm only.    2/20/21 Second shot in afternoon.  By evening, fever 102.8 (then took Tylenol and fever reduced to 101).  Fever, nausea, severe leg pain, moderate low back pain, severe fatigue.   2/21 morning through evening: 101 to 102,  nausea, fatigue.   2/22 fatigue, temp 100 to 101.  2/23 fatigue, low temp 99.0.
1/17/06 received Hep A vaccination #1. 1/19/06 started itching, mild hives. 1/20/06 severe hives, severe itching, started Benadryl. Over days, itching relieved but as of 1/31/06, hives remain. 1/31/06 pt called to report reaction. Pt instructed to see PMD. Given phone no for PHC (Hives from head to foot).
It started with chills...then a couple hours later I was so tired it was a chore to move any part of my body.  I layed down and didn't move.  I started running a temperature of 101, had headaches and joint pain in my knees and back.  My head felt strange.   I slept all day and alll night.  The next morning I felt a little weak but began coming out of it.  By noon I was ok again.
On the morning of March 15, 2021 I got up and noted that I had no vision in my right eye. As a commercial pilot I considered this an emergency and sought specialist care from a retina specialist near our winter home in. That specialist diagnosed an episode of macular edema, caused by an occlusion of a vein behind my right eye. I was treated with injections of Avastin, an off label drug that has been effective in patients with this problem. I received one injection on March 15, 2021 and a second by the same doctor on April 12, 2021, before returning to my home. My course of treatment has continued at Medical Center also with injections of Avastin. My vision is now 20/50 in my right eye. After
Patient is having severe lower abdominal pain and cramping that started on 3/4 2 days post vaccination. She is having trouble standing straight up due to the pain.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates in 2015, the unspecified number of patients were vaccinated with doses of ROTATEQ, (strength, dose, frequency, route and anatomical location were not reported) (lot # K005397, expiration date 29-FEB-2016) for prophylaxis which were improperly exposed to 47 Fahrenheit temperature for 11 hours since an unspecified date in March 2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I tested positive for COVID-19 on 5/17/23. I had a fever, runny nose, cough, and joint pain. I contacted my doctor and was prescribed 5 days' worth of Paxlovid. I am feeling much better now.
I had some slight swelling in my right eye/cheek Tuesday evening and moderate swelling at the shot location in my right arm that stayed until Saturday. I also had mild flu symptoms Wednesday and Thursday with a low grade fever (100).
Normal side-effects subsided after the first few days. Restarted on the 11th at night with difficulty breathing, which later escalated into nausea, pain across the chest, ribcage, abdomen, thighs, calves, toes and re-ememergance of initial vaccine symptoms.