chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID arm; warm to the touch at the injection site; red and itchy area around the injection site; swollen area at the injection site; red and itchy area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (red and itchy area around the injection site), VACCINATION SITE SWELLING (swollen area at the injection site) and VACCINATION SITE ERYTHEMA (red and itchy area around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Milk allergy (soy milk ) and Drug allergy. Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) and ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) for Routine health maintenance, CENTRUM SILVER WOMEN 50+ for Vitamin supplementation, ATORVASTATIN for an unknown indication.    On 20-Feb-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (red and itchy area around the injection site), VACCINATION SITE SWELLING (swollen area at the injection site) and VACCINATION SITE ERYTHEMA (red and itchy area around the injection site). On 27-Feb-2021 at 7:00 PM, the patient experienced VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE WARMTH (warm to the touch at the injection site). On 09-Mar-2021, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (red and itchy area around the injection site), VACCINATION SITE SWELLING (swollen area at the injection site) and VACCINATION SITE ERYTHEMA (red and itchy area around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.  The size of the reaction was rectangular shaped about 3 1/2 inches by 2 1/2 inches.   This case was linked to MOD-2021-107632 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Updated patient demographics, patient medical history, suspect product details, concomitant medications and events On 14-Jul-2021: contains No New Information.
A female patient (age unknown) experienced nausea, vomiting, chest pain, fever, and hypertension on 4/14/01 following treatment with RabAvert for postexposure prophylaxis. The patient was bitten by a raccoon on 4/9/01 and began postexposure vaccination on 4/13/01. On 4/13/01 she received human rabies immune globulin into an around the site of the wound, and RabAvert was given IM in her arm. Approximately 2 hours later, the patient began to feel edgy, hot and sick to her stomach. The next day, she presented to the emergency room with nausea, vomiting, chest pain, fever, and hypertension. She was treated with IV fluids and sent home. On 4/16/01, the patient returned to the emergency room for her second dose of RabAvert. She did not develop any adverse experiences following the second dose of RabAvert. The patient missed her third and fourth doses of RabAvert. She was due into the clinic on 4/30/01 for her third dose of postexposure RabAvert and would then try to complete the postexposure schedule per the approved regimen. The Drug Safety physician assessed that human rabies immune globulin as a secondary suspect product. Follow up information has been requested.
Case stated noted some immediate flushing "by the time I got to my car". reported flushing resolved but then noticed upper body generalized itching. Denied any past allergy to flu shots or eggs. Reported it was her first time getting the intradermal injections. Reports she takes daily allergy medication but nothing additional for itching. Reported no difficulty breathing or swelling. States she is "just itchy".
SEVERE FLU-LIKE SYMPTOMS.  PAINFUL ACHES, HEADACHE, SWEATING ALTERNATING WITH VIOLENT, SHAKING CHILLS, DIZZINESS...LASTING ABOUT 8 HOURS.
SWELLING IN ARM; TONGUE STARTED TO FEEL TINGLY AND HOT; LEFT ARM NUMBNESS AND TINGLING (FELT LIKE PINS AND NEEDLES); HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included: chronic miscarriages, and concurrent conditions included: irritable bowel syndrome, brca (breast cancer gene), seasonal allergy, penicillin allergy, social drinker, and non-smoker, and other pre-existing medical conditions included: Patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with azithromycin, influenza vaccine, and macrogol 3350.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 12-OCT-2021 12:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-OCT-2021, the patient experienced swelling in arm. On 12-OCT-2021, the patient experienced tongue started to feel tingly and hot. On 12-OCT-2021, the patient experienced left arm numbness and tingling (felt like pins and needles). On 12-OCT-2021, the patient experienced headache. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tongue started to feel tingly and hot, left arm numbness and tingling (felt like pins and needles), headache, and swelling in arm. This report was non-serious.
I am confused on which dose I am to report?.I did report my heart palpitations started after my booster which was November,29,2021. It was the worst feeling ever?I  had terrible pounding and rapid heart rate?could not sleep.
About 9 days after vaccination, developed a red, itchy, hot area on arm near injenction site.
Administered MMR, Varicella, Hep A on 5/30/13 at PCP office. Patient started w/ rash all over body on 6/9/13. Dx rash / MMR related.
Severe pain, itching, and rash radiating from injection site & encompassing entire upper arm. Also nausea. Reported by patient on 10/5/12 as lessening overnight.
I had a series of migraines after dose 1 of the vaccine and even more this week after dose 2.; She had a series of migraines; This is a spontaneous report from a contactable Consumer (patient).  A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm on 20Feb2021 (Batch/Lot Number: EN6200) as single dose at the age of 69-year-old for COVID-19 immunisation, administered at school or student health clinic.  Medical history included COVID-19 from Jul2020 to an unknown date. No known allergies. There were no concomitant medications. No other vaccine in four weeks. Vaccine history included: bnt162b2 (BNT162B2), dose 1 administered in left arm on 30Jan202110:15 AM (Batch/Lot Number: EL9261) as single dose at the age of 69-year-old for COVID-19 immunisation.  Since having COVID in July patient had have had more migraines than normal. She was used to get 4 or 5 a year. She has probably had 10 to 12 since July. She had a series of migraines on 04Feb2021 08:00 AM after dose 1 of the vaccine and even more this week after dose 2 in in Feb2021. No treatment received. COVID was not tested post vaccination. The outcome of event was not recovered.    No follow-up attempts are possible. No further information is expected.
About a week after receiving the first shot my arm was itchy. There was a red hot tight area at the injection site. The next day it was raised, still itchy, hot, red, and tight. It gradually resolved and lasted about a week.
A non-serious spontaneous report of inadvertently gave H1N1 to a patient who was recently diagnosed with asthma was received from a physician concerning a 33-month-old male. The patient was a known case of asthma. In Dec-2009, the patient was administered H1N1, Intranasal. Then the patient was diagnosed with asthma and on 11-Jan-2010, the patient received booster dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Lt arm pain, redness and swelling Nausea Headache Body ache Fever Chills Fatigue Taking Ibuprofen to help but symptoms continue going into Day 4.
Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer.  A 72-years-old female patient received the second of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9267, Expiration Date May2021, via an unspecified route of administration on 08Feb2021 (at the age of 72 years old) as SINGLE DOSE in the left arm for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported.  Historical information included BNT162B2 dose 1 for COVID-19 vaccination.The patient developed the sore throat on 09Feb2021, Cough; bad cough on 10Feb2021, constant running nose on 11Feb2021. On 11Feb2021, the patient passed out in the bathroom floor, had an ambulance here. Patient still coughing a little, not as badly. The patient experienced diarrhea in Feb2021. Treatment for all events included cetirizine (ZYRTEC), Triamcinolone (NASACORT), pseudoephedrine (SUDAFED), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). Outcome of the events Passed out, Sore throat, Constant running nose, Diarrhea was unknown. Outcome of the events Cough; bad cough was not recovered
pt recv vax; mild maculopapular rash on face & upper extremities, mild itching;
This spontaneous report was received from a registered nurse refers to a 17-year-old patient, gender unspecified. On 29-MAR-2013, the patient was inadvertently vaccinated with 0.5 milliliter PROQUAD (lot# and expiration date not reported) subcutaneously. No adverse effects reported. No further information provided. Additional information is not expected.
Had a stroke Mar 16, 2021. 12 days after shot. This is nonsense adding all this data. It is as though you don't want to hear. Mistakes on pages are mot clear and easy to figure out. Such as no months if over 2 years of age. Idiotic.
Large raised red warm-to-touch area, at injection site, significantly tender to touch. Not impact on breathing. Child has received influenza vaccines yearly since birth with no previous reaction, as had all siblings. Strangely this child and all siblings reacted in the same way to this vaccination. Concerned about issues with the product lot. No VIS form provided for this child or any siblings from physicians' office. Same lot for all children experiencing this reaction.
Patient received her last GARDASIL #3 and second MENACTRA 8/21/13. She began having headache and pain behind (R) ear and (R) jaw pain 8/23/13. Her family noticed (R) sided facial paralysis 8/25/13. She was diagnosed with Bell's Palsy 8/26/13 and started on prednisone for 10 day taper.
Pt recvd 1st dose of Hep B vax  on 12JAN91; On 31JAN91 pt exp flu sx of achiness, diarrhea, & nausea; sx lasted 1 day; On 11FEB91 pt recvd 2nd dose of Hep B & same sx recurred; pt exp bloating, nausea, diarrhea, fever, jaundice, elbow pain
2jUL96: pt nauseated, chills, arm swollen from shoulder to elbow;tx w/APAP, Ibuprofen, cold compress;4jUL96 bruised, swollen, warm to touch, pain, fever, chills, nausea, dizziness;dx cellulitis;rx ATB;
extremely sick; the second he got up he got horribly dizzy; dizziness; felt like he was going to throw up; throw up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 10:00 (Lot number: EN6204) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2012 (ongoing). The patient took concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "extremely sick"; DIZZINESS POSTURAL (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "the second he got up he got horribly dizzy"; DIZZINESS (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "felt like he was going to throw up"; VOMITING (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "throw up". Therapeutic measures were taken as a result of dizziness postural, dizziness, nausea.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was further reported that he had no effects at all and he did fine for the fifteen minutes. He states he barely even felt the shot, he went out and then came home, worked all day and went to bed and did fine. The patient got up the next morning and was fine. After lunch, he got up and he got horribly dizzy. His wife got him to the bedroom and he felt like he was going to throw up. Patient stated that his wife brought him some bismuth subsalicylate (PEPTO BISMOL; equate version; lot number: CJ07849 and expiration date: Apr2022), and immediately after he took 30 mL dosage, he started to throw up "yellow" (everything that had gone down). He stated that this was 25-26 hours after first dose, and he doesn't know if it was due to the shot. The event "the second he got up he got horribly dizzy", "dizziness", "felt like he was going to throw up" and 'throw up"  persisted about 12 hours and was resolved. The patient next shot was scheduled on Monday, 29Mar2021.  No follow-up attempts are possible. No further information is expected.
The morning  after receiving  the vaccine- muscle stiffness, nausea, fever, fatigue for the entire first week afterwards, on the second week developed worsening fever, intense nausea, chest and sinus congestion, dizziness was unable to work for a week due to severity of symptoms
At 10:30 that night I had a couple of hives, itchy skin all over, and red stomach.
Patient experienced severe tachycardia 4 hrs receiving the flu shot. Was in the ER.
vaccine shortage; COVID got in the way / haven't gotten a second dose; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue and social problem. On an unknown date, the outcome of the product supply issue and social problem were unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had one dose of Shingrix over 2 years ago and then vaccine shortage and COVID got in the way, which led to product supply issue and social problem. The patient did not had a second dose. The patient asked if she just needed to get a second dose or she should start again, do two new doses.
9/10/2019 6:45 pm - Shingrix injectionon left arm 9/11/2019 8:00 am - left arm rash (3 inches below injection location, pink, finger nail size, painful); High Fever (101F-109F) 9/11/2019 8:00 pm - took Tylenol 1000mg, fever gone after 40 minutes 9/12/2019 rash developing (tender, bigger, more painful, ~1 inch diameter) 9/13/2019 rash developing (bigger, more painful, ~2 inches diameter) 9/14/2019 9:00 am went to Clinic, no treatment was given, asked us to go to Emergency Room. 9/14/2019 10:10 am went to ER, doctor was not sure if the rash is or isn't shingles, but provided prescription Acyclovir 800mg 9/15/2019 9:00 am rash getting smaller and pain decreased
Adverse Event: Stillbirth at 36 weeks gestation First pregnancy, normal previously Due date: 5/26/21 Delivery Date: 4/28/21 Fetal Demise determined on 4/26/21 Birth Weight: 6lbs, 2oz
A few hours after the vaccine my arm hurt. The next day (1/5/21) the body aches and nausea started. I wasn't worried because this is well known for side effects from the vaccine but I wasn't prepared for the heart palpitations and tachycardia I had for about 4 hours the night of 1/5/21. I had COVID in May 2020 and per my cardiologist probably had myocarditis that I am still taking a beta blocker for as a result of the COVID infection. There may or may not be a link between the immune response to the vaccine and my previous COVID complications. The morning of 1/6/21, I am pretty much back to normal.
100 DEGREE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 100 degree fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 100 degree fever was not reported. This report was non-serious.
This was an employee that requested J&J, it was not caught that she was under 18. Consents were all signed by parent
The day following 2nd shot of the SHINGRIX I felt flu like symptoms. Stiff muscles, sore all over. Very tired. I slept all day and felt nauseous. Dizzy when I woke up and not hungry. Just needed sleep. That was all day Saturday... the 2nd day. By Sunday, I woke up fine, just a very sore arm.
I had fever, chills, pian in my joint and muscles all over the body. I had fatigue. On April 16th and 17th I could not get out of bed. On May 12th I had to visit the ER because I had inflamation in my eye.  The next dayI followed up with my primary care. I was told inflamtion levels and blood levels were extemely high.
Redness, swelling and itching at the site on day 11. The area of redness was  about 2 ? wide and  about 5? long.  On day 12 it was blanched in the middle of the reddened area., and on day 13 it was completely gone.
Had onset of mild nausea and decreased appetite several hours after dose, then 12 hours after dose develops subjective fever, chills, severe body ache, severe joint aches, severe headache, and mild abdominal cramping
heart palpitations/ my heart would race; hot flashes; flushing; shortness of breath; heavy feeling in my chest; my head would explode; rise in my blood pressure; several bathroom breaks; anxiety; heart beat a little faster; unforgiving fatigue; nightmares; injection site was minimally painful; This is a spontaneous report from a contactable consumer. A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration at the age of 76 years, on 22Jan2021 13:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and obesity from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE). The patient reported that the vaccination was given at approximately 1:30 pm on Friday 22Jan2021, and during the wait time after the shot was given, the patient had no problems, other than what the nurse said was probably anxiety when the patient's heart beat a little faster. The patient stopped at the grocery store, home for a bite to eat and then the unforgiving fatigue. The patient slept from 5:30 pm on Friday 22Jan2021 until 8:30 am on Saturday 23Jan2021 (with several bathroom breaks, but in bed, asleep). One of the problem during that time was nightmares of epic proportions. On Saturday 23Jan2021, the patient began to have semi-serious (enough that patient contemplated an ER visit) heart palpitations, flushing every couple of hours (similar to "hot flashes") and shortness of breath with a heavy feeling in chest, not gasping to breathe. Each and every time the patient got up to work, even across the room, patient's heart would race, as if the patient had been running, and would feel as though my head would explode (patient was assuming it was due to a rise in my blood pressure). These after-effects continued all day Saturday and all day Sunday. The patient did not have the fatigue issue and the injection site was minimally painful. On Monday, 25Jan2021, the heart situation was almost completely gone and I am having very small problems with breathing. The only time the patient seemed to have anything with breathing was when the patient does any extended activity (which is usually one of the normal causes of my asthma). Given the side effects, patient was concerned about my second shot as the patient have heard that shot seems to affect people much worse. The outcome of the events heart palpitations, shortness of breath and heavy feeling in my chest was recovering while other events were unknown.
fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date at 10:00 at single dose on left arm for COVID-19 immunisation. Medical history included depression/anxiety, back pain, COVID prior vaccination and known allergies: sulfa and penicillin. Concomitant medication included naproxen, sertraline HCL (ZOLOFT), fish oil, ospemifene (OSPHENA) and docusate sodium (COLACE), all from unknown date for unknown indication. On 12Jan2021 at 17:00, patient experienced fever 101, headache, chills, muscle pain, weakness, nausea and fatigue. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Nasal Swab on 14Jan2021 was negative. Patient recovered in Jan2021.  Information on the lot/batch number has been requested.
Menactra vaccine administered on 07/20/06 at HD without incident. Pt's mother phoned HD or 7/25/06 and stated that pt had been in bed since Saturday and that pt complained of stiff neck, weakness, lethargy, and poor appetite. Per mother pt assessed by internist and subsequently diagnoses with viral meningitis per result of lumbar puncture. Afebrile per mother.
Stomach pain, fever, chills,. Pain, redness, swelling at injection site. Loss of appetite, exhaustion,.loss of bladder control while sleeping.
Severe Headache, neck, body and joint aches, chills/fever,  no energy
Menstrual cycle started a few hours after injection, 5 days early. On second day after injection, left armpit lymph node became swollen and tender.
t105 APAP given, sponge baths; still had temp 26JUL92 UTI dx put on med;
Immunization given 4-20-04- On the evening of 4-24-04. Child became very irritable & couldn't walk after awhile he couldn't crawl. Had a decreasing grade temp 99.7. Mom reports it was as if he couldn't control his balances. She also reported he had "glazed" look in his eyes. Seen at local ER & hospital. Blood work & Cat Scans normal. Diagnosis of chicken pox ataxia given. No prescription. Child has been walking for past 2 days. Still a little irritable.