chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted and fell off the examiniation table to the floor, resulting in a concussion, broken orthodontice braces in mouth and bloody nose.
Patient reported severely soreness of his arm and went to see his primary physician. He was prescribed FLEXERIL and MEDROL dose pak and he is doing better.
THIS IS A QUALITY EVENT HAPPENED AT THE STORE FOR WRONG SELECTION OF VACCINE. THIS PATIENT WAS SUPPOSED TO GET KIDS PFIZER VACCINE 5 YEARS TO 11, INSTEASD WAS GIVEN PFIZER 12 AND UP GRAY CAP VACCINE (  NO DILUENT NEEDED). THIS WAS DULUTED WITH DILUENT AND GIVEN AT KIDS DOSE 0.2ML ON 02/21/22. STAFF REALIZED ON 02/23/22. CONTACTED THE PARENTS ASAP . NO ADVERS REACTIONS REPORTED AT THE TIME OF CONTACT FOR THIS CHILD.
After 1st dose; pt experienced abdominal pain after 2nd dose; pt experienced increased abdominal pain after 3rd dose; still experiencing abdominal pain; weight loss, decreased appetite.
pt recvd vax 24MAR95 & 28MAR reports to MD exp flu-like sx during preceding days (diarrhea,fever,flatulence,body aches,chest congestion;no fever on 28MAR;no local rxn following vax;seen by MD 28MAR;no treatment prescribed
Patient was administered full dose of oral rotavirus vaccine. She spit up vaccine and it splashed into her eye. Eye was washed out F/u call without mom showed no effect
Age indication; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On 08-SEP-2023, the patient received Boostrix. On 08-SEP-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Age indication).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-SEP-2023 Health care professional (HCP) was unsure if Dtap was to be given and what dose pt. was on in the Dtap series.  No reactions reported. Boostrix was given to a 4 year 6 months old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email
Localized skin reaction, red itchy skin. Followed by two additional lesions. Appeared day after vaccine in location of vaccine. 2 weeks later lesions still present, not resolving. Lesions are red indurated. Appears to have thickened skin in area or lesion.
Within 12 hours, Hives all over (photos on file), shortness of breath, slamming headaches, chest pain. Continued for several days. Immediately reported to the doctor. Headaches have continued as of Nov 10th as well as shortness of breath. Using at home breathing treatment machine which I use for asthma, monitoring pulse ox, heart rate. Doctor was contacted immediately. Also had worse reaction for mRNA shot Moderna Shot 1 in April 2021 so I had waited to get this one until fully head which took 4 months - I saw pulmonologist, cardiologist and St Story on that and was hospitalized.
7 am on 3/27 had fever, chills, muscle aches. Around 1 pm checked temperature at home, was 100.0. At 3 pm temperature was 102..4.  On 3/28 started having blurry vision and pain in right eye.  3/29 continued to have right eye pain and loss of vision. Went to eye doctor appointment and eye symptoms was diagnosed as shingles infection in eye.
10:05AM patient. Reported to the post vaccine observation are: She immediately became lightheaded, diaphoretic, and pale. Laid patient on the ground, placed feet up. BP-131/84 HR-74 RR-16. Patient reported feeling better. We sat her up and continued to monitor, gave her Sprite, and a pastry. She drank the Sprite ad we continued to monitor. Initially, she refused the pastry.  10:35AM Patient became lightheaded once more.  BP-119/76 HR-75 RR-16. Laid her on the floor again with her feet up where she reported feeling better immediately. Patient then ate the pastry.  10:52AM Patient ready and was ambulated around the convention center. She ambulated with assist and had a steady gait. Coworkers to drive her home. Patient advised to call 911 or see her physician with any concerns. Patient verbalized understanding.
Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C021A and 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Abdominal disorder and Pain. Concomitant products included PANTOPRAZOLE for Abdominal disorder, LISINOPRIL, AMLODIPINE and DILTIAZEM for Blood pressure abnormal, TRAMADOL for Pain, PRAVASTATIN for an unknown indication.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            This case was linked to MOD-2021-307173 (Patient Link).
pt recvd HIBTITER/MMR @ 530PM; pt was put to bed 8PM (usual time); woke 12MN & was hyperactive till 630AM, then fell asleep until 8AM; had a nl day & took usual nap @ 2PM; recovered;
The first one i was itchy that night that was it.  The second one three days later getting these little twinges of chest pain every now and then. They seem to be fading away now, but still once in awhile.    Never sought treatment
Itchy; feels warm to the touch; swollen from site of injection to elbow; soreness/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (feels warm to the touch), VACCINATION SITE SWELLING (swollen from site of injection to elbow) and PAIN (soreness/sore arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20a and 013L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MELOXICAM (MOBIC), PARACETAMOL (TYLENOL), METFORMIN, AMLODIPINE and NABUMETONE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (feels warm to the touch), VACCINATION SITE SWELLING (swollen from site of injection to elbow) and PAIN (soreness/sore arm). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (feels warm to the touch), VACCINATION SITE SWELLING (swollen from site of injection to elbow) and PAIN (soreness/sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Benadryl cream.
Since April 10th I am having very itchy rashes that spreader out all over my body. They are worse under my armpit, inner thighs, breast and belly. They do not seem to be going away. I am using anti itch cream and Zyrtec, it seems that I am having measles or chicken pox again. I am concerned it may be shingles  Doctor said better not use steroids so my body can produce antibodies
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number M036728 and expiration date of 20-MAY-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1709USA011980: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Intense chest pains that lasted periods of two weeks at a time. They have been occurring ever since at varying levels of intensity and duration. Went to Urgent Care and ER in December 2021/January 2022 tried NSAIDs, inhaler, and now doing further testing since they have not gone away.
rapid heart beat; headache; left shoulder burned; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heart beat), HEADACHE (headache) and THERMAL BURN (left shoulder burned) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (rapid heart beat), HEADACHE (headache) and THERMAL BURN (left shoulder burned). At the time of the report, PALPITATIONS (rapid heart beat), HEADACHE (headache) and THERMAL BURN (left shoulder burned) outcome was unknown.            Patient received first dose of the vaccine on 12Feb2021. After first dose patient had a headache and left shoulder burned. Patient received second dose on 12Mar2021. Patient had same side effects after the second dose. Patient received booster dose on 23Aug2021. Patient experienced same side effects on third dose and rapid heart beat   This case was linked to MOD-2021-338406, MOD-2021-338314 (Patient Link).
Experienced fullness in the chest that I initially attributed to bronchial or epigastric irritation, then I realized I was having irregular heart beats and a feeling of 'heart irritation'.   I have a stethoscope so I listed to my heart and was able to identify 4-10 irregularities / minute intermittently for the next 10 days.   At times this was symptomatic with a feeling of irritation or congestion in my chest that would reduce with a cough.   I am a runner and symptoms did not increase with exercise and when I started watching closely they  decreased with walking , slow running or my weigh lifting.   Symptoms are receding, on occasion, I feel an irritation in my chest but heart irregularities are subsiding.
Pt states rash breakout under breast and site of injection. There's also swelling and redness. Recommend pt to apply cold compress to area and try not to touch area with hand. Pt also states she had yeast infection. Pt will seek medical advice from PCP if symptoms persists.
Injections site red, hot to touch. Itchy and pain down arm and into neck. Did ice, Benadryl and this helped. 10/04/2019 area at site reddened the size of a golf ball.
Hives everywhere. Diarrhea. Fever. Body aches. Chills.  Migraine
Menstrual problems. I had a period in between the normal menstrual cycle.  My period came at day 16 where i'm 100% of the time on a 26 day schedule. I never have break-through bleeding and i'm pretty clockwork when it comes to my cycle. The period was like a normal period.
pt recv vax & devel redness, induration, warmth & pain @ inj site;
Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 59-year-old female patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: The age at vaccination was not reported. Medical assistant reported that a 59 year old patient received a pediatric dose of HAVRIX, which led to adult use of a child product and underdose.  No adverse events were reported at the time of the call. No further details were provided at the time of the call. The reporter consented to follow up. Consented to follow-up by email.
Large bruise 3-4 in diameter around injection site. No pain, itching, or any other Sx.
Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 18-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 102F, rash to stomach, arms, legs, back and face, Child given Benadryl and Orapred by ER.
15 minutes after vaccine was getting lightheaded and little dizzy. Then 30 minutes after ( now 45 minutes after vaccine) started getting nerve problems behind left eye that was bothering me. Then my face got nerve problems too. Then all my teeth on top and bottom row were hurting. my lips and tongue got numb with nerve problems like I had too much Novocain. Then my throat felt like it was swelling up. I called hot Line of vaccine to report side effects. They transferred me to a Covid 19 nurse that said go to emergency room right away sounds like yiur getting Bell?s palsy.   FYI my brother who lives in another state did not report his side effects. In February he got the second dose of Pfizer and he said four hours after he got nerve problems in his face and his right side of eye and mouth drooped and he was talking strange like someone with paralysis of mouth . Still has it but never went to doctor and won?t fill out info to report
mixed  the ACTHIB with sterile water and administered it/  DTAP/IPV portion was never administered with no reported adverse event; Initial information received on 11-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 100 years old female patient and it was reported that "mixed  the ACTHIB with sterile water and administered it/  DTAP/IPV portion was never administered with no reported adverse event", while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 09-May-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , (lot : UJ621AAA ; expiry date: 28-Jan-2023) via intramuscular route in the right thigh for immunization.  It was reported that on 09-May-2022, the medical assistant went to administer Pentacel to a patient and was confused because she saw the powdered ACTHIB and removed it from box and did not notice the diluent with DTAP/IPV in the box. She mixed the ACTHIB with sterile water and administered it and DTAP/IPV portion was never administered (product preparation issue) (latency: unknown). The patient did not experience any adverse event as a result of this.  Action taken : not applicable.  Outcome: unknown  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 the 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.
Nausea, ringing in ears so bad I felt like I was going to throw up or pass out.  Felt like I was going to get up I would fall over. Slight fever
Pt reported acute flu like sx 1D after rcvg flu vaccine. Same thing happened after rcvg vaccine 2 y ago. Body aches, fever, etc. Pt also reported local swelling, redness, pain at injection site.
On 8/11/2016 patient received the FLUZONE high dose on Right arm and HAVRIX on left. The next day her right arm hurt and is still painful today. Some days it's more painful than others. She describes it as a muscular or nerve pain. It sometimes wakes her at night.
mom reported event long p/states pt cried all day & was inconsolable; MD feels was reaction to DTP & pt now will receive DT when due; pt did not have fever x/for 1 hr nap cried up till 11PM;
Pt given Janssen vaccine per ususal protcol and asked to wait in designated chairs for 15min. After about 7 mins pt came to counter saying she had a pain in her neck and her chest was tight. Pt instructed to sit down, was alert, talking and breathing on her own. 911 was then called so pt could be looked at.  EMS arrived on scene and transported pt
Lt arm swelling, redness, warmth and pruritus x 2 day. Also low grade fever. Given Benadryl x 2. Given Pediapred 3 ml PO BID x 3 days, then BID PO x 2 days.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 34.22 for dose administered on 15-Apr-2021  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Resident hospitalized with Covid-19 on 11/17/2021. 2 falls from weakness related to Covid-19
extreme fatigue, stomach upset, sore arm, could not sleep on that side. achy body, dizziness, so tired, that I needed to sleep most of day the 2nd day. this lasted until the morning of the 3rd day (Friday).
pt states she had lunch from her favorite restaurant at 12:00 pm on 5/8/2021 and about 20 minutes after eating she developed stomach cramps and then had diarhea.  She had feeling of emptiness and had to eat very lightly afterwards since she has had to decrease her portions sizes.  She will have to wait a while before she will be able to order from her favorite place to eat since her appetite is not the same.  Pt has an appt w/ her PCP on 5/13/21.
The day after second vaccine I was constipated. After having irregular bowel movements for a week I went to my primary physician, on Feb 19, 2021.  He prescribed  Metamucil. After taking for 2 weeks I was still bloated and irregular. I then went to my previous gastroenterologist on March 22, 2021 He told me that his office has seen this after the second Pfizer vaccine and scheduled a colonoscopy. Colonoscopoy performed on March 29, 2021.  Results were normal. I have since returned to regular bowel habits.
Itchy arm at injection site, warm to the touch.  Received influenza vaccine in the same arm at the same time. I'm reporting it as starting 5 am on 1/13 however it was slightly itchy 1-2 days prior.