chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ANKLES SWELLING; ANKLES REDNESS; IN PAIN AND HURTS TO WALK; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced in pain and hurts to walk. On 05-JUN-2021, the subject experienced ankles swelling. On 05-JUN-2021, the subject experienced ankles redness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankles swelling, and ankles redness, and the outcome of in pain and hurts to walk was not reported. This report was non-serious.
HUGE LUMP THAT SEEMS TO BE GETTIING WORSEOVER TIME/ THERE WAS LOT OF REDNESS/SWELLING/ITCHING/LUMP HURT TO TOUCH OR LAY ON,/IS QUITE HARD; 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, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Batch /Lot number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced huge lump that seems to be getting worse over time/lot of redness/swelling/itching/lump hurt to touch or lay on, /is quite hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from huge lump that seems to be getting worse over time/lot of redness/swelling/itching/lump hurt to touch or lay on,/is quite hard. This report was non-serious.
Patient received SQ Yellow Fever vaccination in his left upper arm @ ~ 0915 & had a syncopal episode ~ 5 minutes later lasting 5 minutes. Patient kept supine and apparently recovered completely within 15 minutes. Mother given instructions to take patient home with no physical activity for the rest of the morning.  Received a phone call @ ~ 10:10 AM from the patient's mother reporting that the patient had become lightheaded again and vomited food from breakfast. She also indicated that the patient had a fine yellow, non-pruritic rash on his abdomen and had briefly c/o a tightness in his chest, although he was presently not SOB and was speaking in full sentences without difficulty. His mother was given instructions to take the child to the nearest emergency department. She agreed to do so. Approximately 1 hour later I again called the patient's mother to check on his progress. She stated he had been taken back to a treatment room, had been given Benadryl and was now experiencing a decreasing rash with no other symptoms.
Developed rash over trunk and face 48 hours after flu vaccine. Does not respond to BENADRYL.
Patient reported sore throat, cough for over a week; redness, itchiness and swelling at the injection site. Patient used Benadryl gel at the injection site and was prescribed Medrol dose pack 4 mg.
Received expired booster shot >12 hours post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot >12 hours post puncture) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna COVID-19 Booster dose was administered on 07 Dec 2021 Lot 030H21B & MFG Exp. Date: 23 Mar 2022. This vial was first punctured on 06 Dec 2021 at 9:24AM and 25 hours later, on 07 DEC 2021 at 9:45AM it was administered. The vial did not experience previous excursion. The vial was first moved from Freezer to refrigerator on 06 Dec 2021.
20 minutes after receiving the vaccine, this patient began noticing a lot of swelling in her hands. She has a history of anaphylaxis to many environmental allergens as well as medications.  She felt hot/ sweaty/ upper & lower extremity swelling/ gait was unsteady/ itchy swollen eyes/ headache.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 11-APR-2016 the patient was vaccinated with a dose of RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Mild injection arm soreness for 3-4 hours after injection.  Mostly asymptomatic on the day of injection. No constitutional symptoms until 24 hours later.  Then subacute onset of headache, fever 38 C, sweats, sleepiness for approximately 12 hours.  Asymptomatic by 48 hours later.
general feeling of weakness; it's hard to a hard to do things her to walk; yes i''m i got the booster shot on january twentieth and i''ve had a lot of weakness in both legs; the spot or i got the injection this is generate twentieth it still hasn't healed up i'm still getting blood out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2022 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 20Jan2022, outcome "not recovered", described as "yes i''m i got the booster shot on january twentieth and i''ve had a lot of weakness in both legs"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 20Jan2022, outcome "not recovered", described as "the spot or i got the injection this is generate twentieth it still hasn't healed up i'm still getting blood out"; ASTHENIA (non-serious), outcome "unknown", described as "general feeling of weakness"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "it's hard to a hard to do things her to walk".  Additional information: Patient had a lot of weakness in both legs and a the spot or she got the injection this was like 26Jan2022 it still hasn't healed up she was still getting blood out of it but the week or something problems with weakness in her legs she was waiting for the vaccines went off and so this would go away so it's really annoying it's hard to a hard to do things hard to walk just a general feeling of weakness from this so and she heard other people have had this problem too so she did nt plan on getting any more booster this is so her friends had booster they didnt had problems she was the only one that had so that she knew of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced a fever 6 hours after vaccine and has had a headache for the past 3 days.
Left thigh was red and swollen. Pt had a temperature of 103F. Treated with warm compresses and Motrin.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 20-Nov-2011. On 21-Nov-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
Dizziness, Syncope; Cough abd pain, sweathing.  BP 101/53, HR 60; RR 24 -- > 119/59, 67,20 -- > 94/67, 57. Given OJ and water, pt felt fine after drinking water and OJ.  Patient stable and released from vaccination site.
Pt came into clinic for catch up on immunizations was in need of Varicella and MMR along with many other vaccinations. Patient is to old for PROQUAD.
right eye swelling began approximately 4 hours post vaccine and progressed to complete facial swelling and redness. No angioedema, wheezing, or respiratory distress reported. Symptoms relieved with Benadryl.
Two weeks later I was having dizziness spells.  These were ongoing.  If I move around or sat down, it was worst.  I went to my primary care doctor.  He order blood work and urine sample.  I went on September 28th for a colonoscopy, and they found that I had Thrust.
Patient contacted pharmacy several days after receiving the shot complaining of red swollen arm.  Advised patient to try Benadryl cream or capsules bymouth.  Further advised patient to seek medical attention if condition failed to improved or worsen.
Pt states she recieved the Johnson and Johnson vaccine on 4/8 and started have L sided pain from her shoulder to her foot, nubness in her L hand, vision is blurry, and "feels like her blood isn't circultaing correctly". pt states she tried to take bayer asprin today and felt some tingling in her L hand.
20 minutes after the injection started haveing problems breathing, like I couldn't catch my breath. I talked to my charge nurse and I took two puffs of my inhaler. That didn't help and I was getting worse. My face was getting red. my BP was 168/90 and I was getting dizzy. At that point my charge nurse said I need to go the the emergency room. So her and a transporter brought me down in a wheelchair. While on the way down I kept trying not to lose consciousness. Arrived at the emergency room and they put me on oxygen and EKG my blood pressure was still high. The dr assessed me. After while they gave me two Benadryl because I had itching all over my body.   I was given a albuterol to help with my breathing. Was given meds to go home with (steroid for my lungs- can't remember what it was).
pt became itchy, hives, swollen tongue, SOB, chest pain; hypotension; rx fluid bolus, DPH, SOlumedrol, Epi;
Patient received lower dose- 0.25mL administered instead of 0.3mL dose. No side effects reported after administration.
Pneumonia, heart pains from both ribs up to chest, constant fatigue, daily vomiting
<6 hrs after vaccination, (B) ankle pain approximately 10 hrs after vaccination, fever to 102 degrees, myalgias, arthralgias, abd. pain, diarrhea; pain at vaccination site. Symptoms largely resolved by 18 hrs after vaccination.
4/2/2021 11pm left hand red swollen 4/3/2021. Extreme fatigue slept 18 hours very exhausted all day and night,  woke up with face tingling from top of scalp to top of lips across entire area left to right .  4/5/2021. Chills and diarrhea, still fatigued and facial tingling continues 4/6/2021 tingly face continues  4/7/2021 tingly face continues
More than 36 days have passed since first dose, still did not receive second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still did not receive second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still did not receive second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still did not receive second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient still has not received her second shot and her first shot was on 1-May-2021.  No concomitant medications were reported.  No treatment information was reported.
Pain underneath arm getting worse after 4 days. On day 5 after shot was given a rash formed under arm and spreading to chest. Itchy and prickly task. Raised and red in appearance.
The same evening I started to feel very tired; the next day it was exhaustion, no appetite, neck pain, chills, chest pain, low fever, general aching.
Pt vaccinated w/DTP/OPV/MMR developed temp during night after injection called clinic referred to ER. admitted to hosp & placed under seizure precautions.
Pt recvd vax & w/in 20 mins devel small patches of redness & itching; pt returned to MD office & immed took DPH; 17APR93 pt c/o bad h/a in the morning as well as another itchiness attack;
PT PASSED OUT AND HAD A SMALL SEIZURE WITHIN 1 MINUTE OF VACCINE ADMINISTRATION. THE SEIZURE LASTED ABOUT 7 SECONDS. WE LAID HIM DOWN ON THE FLOOR AND MONITOR HIM. HE REGAINED CONSCIOUSNESS AND NORMAL VITAL SIGNS WITHIN 10 SECONDS. WE CALLED 911 AND THE PATIENT WAS TAKEN TO THE HOSPITAL FOR FURTHER MONITORING.
body aches; headache; fever; sick to her stomach; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. In October 2019, 12 hrs after receiving Shingrix, the patient experienced general body pain, headache, fever and stomach discomfort. On an unknown date, the outcome of the general body pain, headache, fever and stomach discomfort were not recovered/not resolved.   The reporter considered the general body pain, headache, fever and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had the first dose of Shingrix, twelve hours later, she was sick to her stomach, has body aches, headache and a fever of 102.6F. The reporter consented to follow up. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the argus it was reported as not recovered/ not resolved.
3 hr after vaccine, H/A, eyes burning, muscle achy, tingling lips, swelling lips and face. Sx continued x 3 days.
About 30-45 minutes in Tongue Swollen, bit of swelling in the throat, heart rate increase, signs of mild/moderate allergic reaction. Never experienced one before.  Upon riding back home, went to urgent care near my house, they treated me with diphenhydramine 25mg (2 tablets).  Stayed there for about 90min. Conditions improved a bit. Went home, took 2 benadryl 10 mg tabs approx every 5 hours. Constant daily improvement. By Friday, conditions were pretty much non-existent.
fever of 101.8.  By AM of 11/01/2010 had acute urticaria
3 hrs p/vax mom noted pt to be limp, blue & groaning or grunting; episode lasted 5 mins; pt admitted to hosp for observation;
1 of 2 pts who presented w/fever & cellulitis;pt vaxed 2NOV94;MD visit 3NOV fever 102.6;arm was red & tender;dx cellulitis;no culture taken;tx Rocephin & ceclor
On 04/07/2021. Lot# 032B21A.-1st shot fatigue,  vertigo intermitantly for 5 days, Sore arm.            Lot# 027C21A -Fever over 100 for 2.5 days with Tylenol every 3 hours, nausea,  aches and pains, fatigue, vertigo/dizzy when standing,  headache,  Sore arm.  Later noticed, ttitinitus (ringing in ears) got worse and migraines increased (still occurring  in October 2021)
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 30-year-old male 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 9:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:49 AM, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 30.66 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 on 9 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).
Received ZOSTAVAX vacc by hospital on Fri 4/30/10, by that nite he had shingles not at vacc site - Placed on VALTREX.
Intermittent Fever of 100F; Half Dollar Size Hives Type Rash; Initial Report Received on 12-Apr-2022  A registered nurse reported that a 47 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed an intermittent fever of 100 °F, and a Half Dollar size "Hives Type" rash over her entire body.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (details not provided).  On 08-Apr-2022, the patient received the second dose of HEPLISAV-B (Lot # 934967, expiration date 11-Apr-2022 and NDC # not reported) in the left deltoid.  On 09-Apr-2022, 2 days after having been vaccinated with the second dose of HEPLISAV-B, the patient experienced an intermittent fever of 100 °F, and a Half Dollar size "Hives Type" rash over her entire body.  The patient reportedly did not have a reaction after having received the first dose of HEPLISAV-B.  At the time of the report, the reactions were still occurring. No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Patient called our clinic on 3/24/2020 to let us know that he had a "bad reaction" to his first Shingrix shot. He reported having a swollen eye, shakes and chills and he went to the ER.  When he was at the ER he didn't even think to mention that he had gotten the vaccination.  ER providers weren't sure what was going on with him during the visit and suggested that he follow up with his PCP.  He states he started thinking about what could have possibly caused him to feel like that.  He remembered that he had his shot and called one of his friends who is a DO and he suggested that he may have had a reaction to the Shingrix vaccine and he suggested that he start to take Valtrex, his pharmacist also agreed. Patient took Valtrex and said it's better now.  He decided to cancel his apt for the second shot. "I don't want to take any chance that I will feel like that again."
Local Reaction at injection site, redness, swelling 10-17-08. Left eye blurred vision 10-22-08.
arm w/11cm x 11cm red & swollen; t101 seen by MD; Naperson ordered; 16JUN92 pain & inflam x 3 wks;
Acute onset fever up to 103 degrees - difficult to control with antipyretics x several days Body aches mild abdominal pain slight cough No other concomitant illness to explain the fever;  influenza negative
Employee reports: "I developed a lump at the site of the injection. It's kind of gone away, it's still there but not as big Today I just noticed a lump in the front of my neck, that's like a big grape. It is my lymph node, yea." Narrative:
02/26/2021 Vaccination; 03/02/2021 Within first week, I had problems walking and weakness on L side of body. It was almost like something affected my nerve system on my left side as I had been walking 4 miles per day prior. It would hit me the 2nd mile and I would have to 'calm it down'. L hip, L leg, L foot shooting pain. Dr recommended spinal MRI. Done at (privacy). Found L5 side arthritis and L4 bit of a herniated disk. I did physical therapy for 5 months and got back to where I was. Before I got my booster, I went back to my dr. and asked what my antibodies were. I was curious; it was positive. My pharmacist stated I most likely had COVID but they had all previously been negative.
Pt complained of pain in shoulder hours after injection (IM, left arm). I informed her it was likely not an ADR d/t location.