chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt c/o lightheadedness 15 mins after receiving his 2nd dose of the vaccine, he had no reaction to 1st dose at site but reported that he felt a little weak a day later. He has Hx of HTN and hyperlipidemia. His last meal was 2hrs ago. He was assessed and monitored by NP, EMT, and paramedic. BP - 129/64, HR - 75, O2 sat 98% on RA. He was offered H2O and something to eat but refused. He was kept until he reported that he felt better and had no other complaints. He was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911, follow up with her PCP and to register with V-safe. He verbalized understanding and willingness to comply. He left site with wife in no acute distress or any other complaints, awake, alert, oriented to person, place, time and situation.
PATIENT STATES THE ADMINISTRATION OF THE VACCINE WAS PAINFUL DURING INJECTION; HER ARM BRUISED AND SHE STILL HAS A HALF DOLLAR SIZED BRUISE AT THE INJECTION SITE TODAY, 12 DAYS POST VACCINATION
Constant crying >24 hours, sleep X 30 minutes at a time max. Tylenol was given every 4 hours, 20 minutes before and 4 hours X 2 days, post vax. Temperature of 102F per mother, 24 hours, post vax. Recommended alternating with ibuprofen every 4 to 6 hours. Also, has had increased fussiness.
started feeling like flu; Arm started to hurt; Red like the size of a 1/2 dollar; Nodule; Very hot; Trouble raising her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot) and MOVEMENT DISORDER (Trouble raising her arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot) and MOVEMENT DISORDER (Trouble raising her arm). On 28-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (started feeling like flu). At the time of the report, LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot), MOVEMENT DISORDER (Trouble raising her arm) and INFLUENZA LIKE ILLNESS (started feeling like flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of MMR II (HSA, lot# K001230 with expired date 27-JAN-2016, lot# K014833 with expired date of 14-SEP-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine given 11/6/14 about 9 AM, child was fussy that night mom gave TYLENOL about 10:30-11pm -> hives within 1/2 hour of TYLENOL. Mom also notes that she did have red spots around her mouth after the vaccine was given. Child was given BENADRYL about 12 am. No hives since (seen in the office 11/7/14 about 2:45 pm).
No current adverse events, however, I am 22 weeks pregnant and I was given the nasal H1N1 vaccine.
11 pm pm 3/17: Developed chills and minor headache. Nausea. Took 600mg ibuprofen.  11:30 PM: developed low fever and body aches. Nausea,   5/10.  1:00 AM: Fever ~101, severe chills  2:30 AM: severe body aches and joint pain 3:00 AM: 103* fever. Chills.  3:30 AM: took 600mg ibuprofen.  6:00 AM: Sweats with 100.5-101* fever.  6-11 AM: Sweats continued.  12:00 PM: sweats and body aches subsided. Nausea and headache 1-2/10 severity.  Ate.  2:30 PM:  body aches and chills restarted. Nausea increased. 600mg ibuprofen.   3:45 PM: Body aches and joint ache increased in severity.
16 year old patient fainted after receiving the HPV vaccine. Vitals checked BP/ 100/60 ,Temp 98, Hr 60. Treatment was given and inhaled ammonia she responded immediately. The patient was observed by the nurse for 15- 20  minutes. She was able to be discharged with no further complications.
NO adverse event. Vaccine administration error. Patient already completed Hep B vaccine in 2019 with 3 doses. Was given Heplisav-B
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date unknown). On 20th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were provided as follows: The reporter was a registered pharmacist. The patient received SHINGRIX in left deltoid. The patient experienced fever of 102 degree F on the same day or next day of vaccination and then low grade following the next two days. The patient had returned for 2nd dose and seeking information about potential repeat or worse of the fever with the 2nd dose. This was texted to the medical information system (MIS).
pt devel visual problems & h/a;dx as optic neuritis lt eye;responded completely to pulse solumedrol;w/in 1wk of stopping neuritis recurred;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Patient had an anxiety attack after receiving flu vaccine. Patient was dizzy and skin was pale and clammy, lasted approx 15 minutes. Mom stated "on occasion he passes out, he passed out at doctors office recently after receiving a shot". He vomited undigested food and felt better. Had him lay down with ice to back of neck and head and soon he felt better. HR=64. Patient improved and left with mom.
Serious health crisis; Vaccine injury; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 21Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced serious health crisis and vaccine injury on an unspecified date (6 weeks later). Consumer reported her husband received his second does of the Pfizer Covid vaccine on 21Mar2021. About 6 week later he started developing symptoms that evolved as time went on. By the end of Jun, he was in a serious health crisis. After much bloodwork and testing, it was determines that he had a vaccine injury. His symptoms mirrored Covid long-haul yet he never had Covid. He tested negative for Covid and has no antibodies to Covid. We are looking for strategies to help him recover. The patient underwent lab tests and procedures which included blood test: he had a vaccine injury (After much bloodwork and testing, it was determines that he had a vaccine injury), investigation: he had a vaccine injury, sars-cov-2 test: negative (He tested negative for Covid and has no antibodies to Covid) on an unknown date. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
It started under both arms little red dots, then noticed it on thighs. spreading behind right knee, stomach, and lower abdomen.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high and cholesterol high. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY); pr (unspecified) (MANUFACTURER UNKNOWN) all from unknown date for unknown indications and unknown if ongoing. The patient previously took amoxicillin and experienced drug allergy to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 03Apr2021 at 09:00, the patient experienced little red dots in under both arms, then noticed it on thighs, spreading behind right knee, stomach, and lower abdomen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with Aller-tec . Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent SARS-CoV-2 test and the result was negative. The clinical outcome of the event little red dots in under both arms, then noticed it on thighs, spreading behind right knee, stomach, and lower abdomen was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pain in arm. Heightened pain in joints. Generalized aches soreness all over. Low grade temp 24 hours plus. Fatigue. Weakness. Unable to attend to normal work/activities.
Waxing and waning rash on upper torso and arms that started the morning after she received the flu shot. She had a flu shot last yr which was the same formulation as this yr. She reports having a sensitivity to all medications.
Patient reports being ill since 7/13/21 with fever, cough, n/v, chills, headache.  Better now, only left with lingering body aches.
The nurse inadvertently administered 0.3ml of Janssen to a 12-year-old. She thought she was administering an adult Pfizer.
This spontaneous report has been received from a registered nurse (also a healthcare worker) via the article of social media referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL (disposable syringe, dose, frequency, route and lot# not reported). Concomitant therapy was not reported. On an unknown date the patient experienced migraine headaches and immune system issues as a result of GARDASIL therapy. The outcome of the events was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Diagnosed by doctor as shingles after second pfizer dose. Severe reactions includes immediate blisters and boils all around the skin of left leg; chronic pain in left foot and leg that lasted for more than a month, separate from the shingles infection, also after second pfizer dose. Numbness still persists to this day in that same area of body. Could not walk for nearly a month and then caused a limp.
Fever from midnight to 9 am when I took a Tylenol. Fever was 100.4 degrees & subsided. During the afternoon I experienced 2 falls. My vision became blurry and I collapsed.  I don?t know how it happened - it seemed that my legs just stopped working.  I was not dizzy.  I had a feeling of nausea several times, but it subsided.  I stayed in bed most of the rest of the day.  I am fine today - April 1, 2021.  I just thought people should be aware that this could happen.  I could easily have hurt myself, but did not.
I was dx with clotting disease, Antiphospholipid syndrome following the first two Moderna vaccines. I had complete opposite issue prior with bleeding before vaccinations. After booster shot, I was very ill for 48 hours following. Did not feel like myself since booster. Had multiple small strokes 1 month after Booster shot on 12/25/21 at 9:30 in the morning. Had to go to emergency room. MRI confirmed brain infarct in multiple areas of left hemisphere of frontal and parietal lobes. Had TIA about a week later, and was admitted to hospital for two nights. I am now on blood thinners because of the clots. Having to take shots every 12 hours.  I have been out of work every since the morning when this all started. I have brain fog and issues that prevent me from working right now.
Pt. complained of blurred vision about 10 mins after injection of GARDASIL. Denied lightheadedness, dizziness or ringing in ears. This improved, then resolved by 25-40 min after administration of vx.
In early May 2021, I was itching from head to toe. The itching was very severe. I was causing myself to bleed from itching so much.  I went to my dermatologist she diagnosed it as unspecified/ nonspecific dermatitis. She prescribed a cream, Triamcinolone acetonide cream 0.1% to use. I have not had to use the cream as much. But in June, July and August I was using it on a daily basis. The itching has subsided but the swelling has not. 6 or 8 weeks ago, I had swelling on my left breast. I went to see my doctor on 08/19/2021. I had a mammogram. They did not find cancer. I still have the swelling now. I did hit myself hard on my chest, so it may not be associated with the vaccine, but I do not know.
Temperature excursion; No adverse event; Patient received moderna bivalent vaccine after a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 2.5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion).    No concomitant medication information was provided.No treatment medication were provided.  It was reported that the patient also received 2 primary monovalent Moderna covid-19 vaccines.Storage condition at the time of the excursion was reported as  refrigerated storage.Vial undergone the temperature excursion for 2 minutes below temperature range at 12:11 PM and 5 minutes at 12:31PM. Maximum or minimum temperatures reached was reported as 35.4°F minimum, 47.4°F Maximum. And no notable visual change was reported .The vial was moved from freezer to refrigerator on 08-Sep-2022 . At the time of reporting the vials were returned to the refrigerator within the recommended temperature range.
Red line from the injection site down to the elbow. Over the course of 2 days redness spread down the arm to the elbow and around the arm. Checked area on 1/28, redness has lightened but still very large area.
My husband had a rash all over his body, high fever and pain/swelling. He was diagnosed with Adult onset Still disease.
4 inch long red area at injection site appeared and gradually faded over three days. No itching or swelling.
20mins post vaccination, pt reported feeling hot while sitting in observation and clamminess on forhead noted. No dizziness reported. Taken to back med room. NO other adverse symptoms reported. Vitals: 14:17 107/69, 52, 20, 97.9F, 100% O2 Sat -- > 14:27 106/69, 63, 20, 100% Pt given orange juice and water.  pt ambulated on her own.  no dizziness reported.   Pt reported feeling better after dinking fluids.  Pt educated to eat and drink beofre needlesticks in future as pt reported that she did not have lunch before coming. Pt reported feeling back to normal before leaving facility @14:30.  Pt had steady gait and no s/s of distress.  Pt stable and released from the vaccination site.
Information has been received from a physician concerning a 2 month old male who on 24-JAN-2008 was vaccinated with ROTATEQ.  Vaccinations received the same day included PEDVAXHIB (OMPC) (manufacturer unknown) and PREVNAR.  It was reported that all vaccines were given pediatric.  On 25-JAN-2008 the patient presented with diarrhea, smelly like rotavirus diarrhea, green.  There was no mucous, no blood and no vomiting.  The lot number was unavailable.  Additional information has been requested. 06/02/2008 Follow-up information was received from a physician and other health professional. It was reported that the 9 week old (also reported as 2 months) male patient was vaccinated with the first dose of ROTATEQ (657664/0975U) PO on 24-JAN-2008 at 10:00 AM. On 25-JAN-2008 at approximately 10:00 AM, the patient experienced diarrhea, foul odor, green in color and diaper rash after ROTATEQ ingestion. There was no illness at the time of vaccination. There were no pre-existing allergies, birth defects, or medical conditions. The patient recovered on approximately 10-FEB-2008. No further information is available.
down and out; couldn't wake up for a while/ sleepy; sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (down and out), SOMNOLENCE (couldn't wake up for a while/ sleepy), PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. 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 FEELING ABNORMAL (down and out), SOMNOLENCE (couldn't wake up for a while/ sleepy), PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (down and out), SOMNOLENCE (couldn't wake up for a while/ sleepy), PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was unknown Concomitant product is not provided. treatment is not provided.
Blood pooling on arm at injection entry point. Pooling had a radius of 2 inches around the injection entry point with pain. Next day additional symptoms began and include severe nausea and vomiting. All symptoms cleared after 14 days with little bruising remaining at injection entry point. During symptoms, patient was bedridden.
Patient recieved the Shingles vaccine on 11/8/07 and she called to report hives, swelling and redness at the site on 11/27/07
Moderna vaccine was administered in error to 17 yo female. No adverse effects are noted at this time.
Hives waist to knees, bilateral wrist/ankle itching, numbness/swelling to lips. Difficulty taking full breath. Pt given BENADRYL to resolve issue.
problems with my feet / kinda up to my knee; Most of the time it is my right foot but sometimes it is in my left / she can no longer walk 10 miles a day; has been "miserable" for her; how bad her walking is now; pain is affecting her hip and knee from her "foot giving into it; This case was reported by a consumer via call center representative and described the occurrence of limb discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included gabapentin.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia. On an unknown date, the outcome of the limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia were not recovered/not resolved.   The reporter considered the limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia to be probably related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that after she got the Shingrix shot she started having problems with her feet mostly the one on her right side and kinda up to her knee. The patient had bloodwork done, went to a foot specialist, also went to a vascular doctor but nothing was showing up and wanted to know had anyone else reported this. The patient reported most of the time it was her right foot but sometimes it was her left. The patient stated she never had this problem until she got Shingrix shot. The patient was seeking treatment recommendations. The patient stated that the doctors that she was going through were not coming up with any answers for her. The patient reported this to the pharmacy where she got the shot but they said that there was no way her problem could be due to Shingrix. The patient believed that the event was related to Shingrix because she stated the problem did not start until after the shot. The patient stated that it had been miserable for her. The patient gave an example: she said prior to the shot last summer, when she was on vacation, she was walking 10 miles a day but after the Shingrix shot she could no longer do that. The patient would have use a scooter, if they go back to the same place this summer, because of how bad her walking was. The patient stated the pain was affecting her hip and knee from her foot giving into it. The patient said they had her on gabapentin which she said helps some but even after they increased the dosage she was still dealing with pains. The patient stated it was devastating and the foot doctor might give her a shot. The reporter consented to follow up.