chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain around the right eye socket, 2 days after the vaccine. Pain starts around early morning and goes till later in the night. I have never had such type of pain in my life. Today is the 13th day of pain- Based on the doctor's prescription- I took Ibuprofen but that is not working either. Please let me know what to do. Going to urgent care again to see the doctor. I also went to see the eye specialist twice- They said there is nothing wrong with eyes. Everything appears normal.
Several minutes after vaccine started feeling tightness in her throat and a rapid heart rate. Administered epinephrine pen and when to the emergency department. Received oral Benadryl and steroids. Was discharged home later.
The initial shot was fine didn't even feel it. Then started to feel burning at injection site. After leaving stadium. My whole right arm and fingers were numb it went up to my nose and my nose felt numb like when you are at the dentist's office. It also felt like something was sitting on my chest. Following day I had to take two Benedryl because my tongue started to swell in my mouth and my hands, face and toes were swollen as well. I have pain in my arm at and near the injection spot. While lying down. I had Ungles over my body. I had to take a second dose of Benedryl due to the same thing happening later in the day.
Fever 100 to 101.  Pain, redness, swelling in entire upper arm with pain radiating into chest wall.
My son received the vaccine around 10:00am on 5/13/2020, he started to feel warm at 6pm and by 9pm he had a fever of 103.1 (rectal). For the next 48 hrs + he had a temperature between 100.6 and 103.1. Sleeping a lot, decreased appetite (he was taking milk and some water), irritable. No cough, no runny nose, no congestion. He was making urine and having bowel movements. He was given ibuprofen when necessary and we put him in a cool wet onesie and hat to draw the heat away from his body. In the morning of 2/23/2020 he woke up without a fever and never had one again. He then developed a diffuse rash that started on this trunk and spread to his arms and legs. This rash does not seem to bother him. It is now 5/20/20, he continues to be intermittently irritable, putting his head down on the floor and sucking his thumb and then getting back up (did not do this before), easily distracted, rash still there. Although we were in contact with the pediatrician, over the phone, we did not need to bring our son in as the fever did not make it to the 72 hr mark.
Initial report received from a consumer, who is also the patient's parent, on 23 March 2012. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of sanofi pasteur. A 20-month-old male patient had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later "stopped talking, acted funny, lost interest in everything and everybody, had no eye contact and would bang his head on the floor like he was frustrated." The patient received speech and occupational therapy. The patient "slowly pulled out of it with a lot of help." The patient "still gets speech therapy and is in kindergarten." No further information was available at the time of the report. The patient's outcome not reported. Documents held by sender: None.
Sore arm for 2 days, then fine. On Day 8, my arm became sore again, had slight swelling, itching, and spreading redness. On day 10 (today) I still have these symptoms. I took an aspirin before bed on days 8 and 9.
2 hours after vaccine-Sudden fatigue 3 hours after vaccine-Throat irritation  and hoarseness with mild coughing  5 hours after vaccine- hoarseness, some throat irritation.  Eye redness of both eyes and a lot of pressure behind eyes and upper nose.  6.5 hours after vaccine-Eyes have gotten more red, fatigue continues. Facial pressure continues. Headache. Body aches. Hoarseness.  No fever as of yet.
Left arm chest above breasts to band above abdomen,,,rash like chickenpox itchy and later scab. I already had chicken pox. 7 days after 2nd shot. Lasted 3 weeks itching. also left ankle inside. itching painful red bottling without rash. 2nd issue a pain in jaw that felt like artery burst. Huge pain then heart pain gripping. Spread to stomach and receded after 3 waves lasting total 15 min. Emt gave aspirin and ER monitored. this occurred April 19 I think. Went to cardiologist who saw a  potential issue so I'm due a stress test to see if heart muscle shows any darkness. 1x event. No prior history. No strenuous activity or stress. was sitting as usual in lockdown.
Numbness of hand and legs, cough, dizziness, nausea, malaise, muscular pain, gastrointestinal disturbance, face an throat rash.
Had low grade fever, fussy, gagging about an hour after immunizations.  At 8:00 p.m. on 12/6/10, she had a difficult time catching her breath, very fussy, had projectile vomiting.
Information has been received from a consumer concerning her 15 year old daughter with no medical history and no drug allergies, who on 02-JAN-2008 was vaccinated with a first dose of GARDASIL. Concomitant therapy included YAZ, used for acne and "bad periods." On 02-JAN-2008, immediately post vaccination the patient experienced severe pain and swelling at the injection site of her right arm. The patient experienced nausea and severe headaches. The patient felt tired and weak. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had recovered from the pain and swelling and was recovering from the rest of the symptoms. No product quality complaint was involved. Additional information has been requested.
approx 10min p/vax pt c/o SOB w/swelling of the rt lower lid, hives & excessive tearing of rt eye;pt was given epi & observed for 30min;decreased ocular swells & resolution of hives;
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 22nd June 2018, 99 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 22nd June 2018, the patient went to her doctor and diagnosed with shingles. The patient was currently on acyclovir for shingles. The health care professional was asking when the patient could receive the 2nd dose of SHINGRIX. The health care professional did not have any further details at the time of the call.
Nausea, upset stomach, vomiting, light headedness, sweat, shaking. Few hours after vaccine administration. Resulted to ER visit and overnight hospitalization.
Pt recvd 1st dose of Hep B vax on 3MAR91 & exp arthralgia & severe malaise;
HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark; no adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark).    No concomitant medication was reported. The vial was initially stored in the refrigerator on 06-MAR-2023. The vial did not undergo any temperature excursion.  No treatment information was reported.  This case contains information for patient 5 out of 10.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
Pt had itchy throat, tight throat, sense of doom at 30 min obs mark. Was given EPI and transferred to local ED. Had rebound anaphylaxis days later (3 days after) resulting in 2nd ED trip.
p/vax pt exp fever; chills; body aches; h/a; nausea; arm from shoulder to elbow red; purple; yellow so swollen; looked like popeye's arm; so sick like pt had flu; swelling pain arm & neck x6day
Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 70-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt tired). At the time of the report, FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
pt fully vaccinated against COVID but then developed + covid test and required hospital admission on 9/29
Pt fasted for a blood draw at 10:00 am on 10/7.  She ate a peanut butter sandwich at 11:00. This is much later than she usually eats. At about 11 she felt cold and hot alternately.  She felt nauseous.  At 1 pm she vomited lots of tea colored fluid. At 2 pm she vomited bile.  She then slept until 5:00 pm and had a light supper and spent quite a lot of time on the exercise bike.  This was a new activity for her.  She experienced leg cramps until 2 am. Pt was well by 10/8.
Patient c/o tingling and stiff muscle on left side of the neck. Feel normal after 2 minutes. Cleared by nurse on site.
Patient felt lightheaded and dizzy approx 15-20 min after injection. Blood also drawn after injections.
Unresponsive/laying in bed still; Sleepy and stayed in bed after getting vaccine; pale; eyes half open and foam coming from mouth; A spontaneous report was received from Pfizer concerning a 66 year old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being unresponsive/laying in bed, sleepy and stayed in bed after getting vaccine, pale, and eyes half open and foam coming from mouth.  The patient's medical history was not provided. Concomitant medication use was not provided.   On an unknown date, the patient received unknown dose number of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection.   On an unknown date, the patient, who resided in a senior home, stayed in bed the dat after getting the vaccine. Early the next morning, he was observed in bed lying still, pale, eyes half open and foam coming from the mouth. He was unresponsive. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of unresponsive/laying in bed still, sleepy and stayed in bed after getting vaccine, pale, and eyes half open and foam coming from mouth/ was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Monday afternoon, January 25, I started feeling achy and chilly.  Just not well.  I work 5 a.m. to 1:30 p.m.  I went straight home from work.  I took shoes off and got in bed.  I was very cold and felt that the coldness was from inside out especially in my hands.  I covered with a sheet and 3 blankets with an extra blanket to my feet and used winter gloves on my hands.  I got up at 5 p.m and felt better.   Tuesday morning, January 26 at 3 a.m. when I got up to shower,  I noticed a soreness and large swelling under left armpit, ? lymphadenopathy.  All others symptoms had passed.  Continues to be the same on today, January 27.  Seeing MD on Thursday, January 28.
4/14/21 Per Patient, received Janssen vaccine on 3/5/2021, began experiencing headaches on side of face and intermittent sharp left leg pain 3/12/2021, does not usually get headaches and thought related to dental work, 4 tooth implants, evaluated by dentist who said headaches not related to dental work, had been more active, walking with nice weather and thought leg pain might be caused by tick bite, left knee "gave out", husband looked at back of leg and did not see any evidence of tick bite, noticed varicose veins had worsened (more prominent, not red or swollen) and thought should be checked, appointment at center 4/8/21 and is under the care of Dr, has follow up appointment 4/21/2021.  Placed on blood thinner Xarelto 15 mg tablets, 2 tablets daily x 21 days, then reduced to 1 tablet daily x 22 days for blood clots. Headaches and leg pain improved after starting medication. Signed up for program 4/13/21 after suggested by daughter.
Patient was supposed to receive pentacel vaccine, which included a combination of Dtap, Ipv and Hib. Only gave patient the Dtap and Ipv portion of the vaccine. Did not mix the vaccine with the Hib portion. Patient did not receive the Hib portion. This is an administrative event.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Neck Stiffness-Medium, Additional Details: Patient reports having significant arm pain for approx three days along with soreness and stiffness extending up entire arm and up into neck. Arm soreness last for about 3 days. Neck stiffness improved slowly but patient still reported some stiffness at time of second dose 4 weeks later. Injection site had a rash and some swelling that lasted for approximately one week
severe shortness of breath and wheezing within few hours from the vaccine. that resolved with IV solumedrol.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 03-Sep-2020. Family history included Psoriasis. Concurrent medical conditions included Graves' disease since August 2017. Concomitant products included LEVOTHYROXINE for Hypothyroidism, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VITAMIN D [VITAMIN D NOS] and VITAMIN B6 for an unknown indication.    On 31-Dec-2020 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Nov-2020 and the estimated date of delivery was 06-Sep-2021. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 31-Dec-2020, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Previous pregnancy end date was 3 Sep 2021 and outcome was spontaneous abortion. Patient was not taking Alcohol, Nicotine, Marijuana and Other illicit substance use.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Received telephone call stating that he has been having frequent nose bleeds since the date of vaccination. States it is as frequent as 5 times per day with a steady amount lasting approx 5 min.
rash at injection site/ rash increased in size over three days; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at injection site/ rash increased in size over three days) and INJECTION SITE PRURITUS (itching at the injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE RASH (rash at injection site/ rash increased in size over three days) and INJECTION SITE PRURITUS (itching at the injection site). At the time of the report, INJECTION SITE RASH (rash at injection site/ rash increased in size over three days) and INJECTION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  The events are consistent with the known safety profile of the vaccine.
Patient received the PNEUMOVAX 23 vaccine on 11-11-16 and returned to the pharmacy on 11-13-16 to pick up an antibiotic because she had a red inflamed area on her left/inner upper arm with red streaks leading away from the area. She claims that she discovered it the morning of 11-13-16 and went to the MD because she was concerned. The red area was located about 4 inches away from where she received the IM injection. The patient stated that the MD was not sure if the red area was related to the vaccine. The patient is now taking antibiotics (doxycycline 100mg) for 7 days to treat.
Nausea, low grade fever, chills, body ache, head ache, lymph node pain and swelling in left arm pit, fatigue, pain and swelling at the injection site. Rested on the couch, huddled under a blanket from about 12:30 on Saturday afternoon till about 11pm when I then went to bed.  During the day on Saturday I took at total of 4 ibuprofen, spaced out, and slept on an off.  By 6:30 am Sunday when I woke up, still a little fatigued, and slight body aches and still lymph node swelling and pain.  Went about with normal routine on Sunday, just a little slower.  By Monday morning the only side effect left was the lymph node pain and swelling and pain around the injection site.  At the time of this report, about 7 pm Monday, the lymph nodes are almost pain free, the injection site is slightly painful when touched.
Shortly after receiving vaccine (within 5 minutes) , reported symptoms of tingling to lips, became pale and felt weak.  Did not pass out.   Vital signs were stable.
Patient moved arm during administration and received < half of the dose. Dose repeated in clinic same day.
No adverse event reported by patient but contacted the patient and informed them that the dose they received was given after the beyond use date
pt recv vax 18JUN96 &  same day exp rash, sore throat & sore lymph nodes;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Fifteen min after the infection; he states, " I can't breath".  " I don't feel right".  States,  he feels like he cannot get his breath.  c/o dizziness and lightheadedness. Denied chest pain.  Facial flushing appreciated;  vital signs included;  his skin was clammy.  187/71 : HR 118 Pulse ox : 94% 02 placed at 2 liters per nc.
severe headache, muscle soreness, fatigue, restlessness, insomnia, arm very warm and red
No additional AE reported; an expired VARlVAX was administered to a patient; This spontaneous report was received from an officer manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 23-MAR-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength was not provided; lot# was s004091 and expiration date was 11-FEB-2021) 0.5 mL once for prophylaxis (expired product administered). The vaccine had not had any prior temperature excursions. No additional adverse event was reported (no adverse event).
Pt got the shingles vaccine on 5/27/17 because she was worried about getting shingles (she has had it twice in the past). She said after getting the vaccine she was very tired and didn't feel well. The arm she received the vaccine in got red and swollen. She broke out in a blistered shingles rash on her right side on 6/4/2017. Pt showed me the rash on 6/9/17.