chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A rash showed up a week after and other rash sites started to show up - underneath injection site and also the back of my left arm. Also, on my right foot. There was three different spots on my right foot. Close to my right heel inside my ankle. On the top of my foot - half way between big toe and ankle. And also under my big toe. It was itchy and warm to the touch. I called the doctor after a week of having the rash - I thought it was bug bites, at first. After a week, the rash spots became bigger. My doctor had me send photos and then she referred me to dermatology. Treatment - hydrocortisone cream and Benadryl
Hip stiffness in both hips; Feeling sleepy; Tiredness/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Hip stiffness in both hips), SOMNOLENCE (Feeling sleepy) and FATIGUE (Tiredness/Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04FC21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced JOINT STIFFNESS (Hip stiffness in both hips), SOMNOLENCE (Feeling sleepy) and FATIGUE (Tiredness/Fatigue). At the time of the report, JOINT STIFFNESS (Hip stiffness in both hips), SOMNOLENCE (Feeling sleepy) and FATIGUE (Tiredness/Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the Reporter. No Treatment medication was provided by the Reporter.   This case was linked to MOD-2021-260330 (Patient Link).
Swollen, tense, and red right upper arm, around injection site. This occurred 72 hours after vaccination and resolved in 3 days.
does have a compromised immune system and he is given Bivigam via IV on a monthly basis; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient receive BNT162B2 (reported as COVID-19 vaccine, unspecified manufacture, lot/batch number and expiration date were unknown) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He got to a second and noticed something. He had a compromised immune system and he was given immunoglobulins human normal (Bivigam) via intravenous on a monthly basis. Patient wondering if this is okay with the vaccine. The outcome of event was unknown.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.  Information on batch number has been requested.
The patient was to receive the bivalent vaccine and received the monovalent vaccine instead.  No ill effects were seen at all.  Patient was notified of the error. Repeat vaccination to occur based on CDC guideline of 3 months.
About 4 hrs after shot(9:15pm) runny nose,coughing, drainage thru throat, headache,about 10:00 was chilled and couldn't get warm,eyes ached and crusty, heart rapidly pounding, chest pain, light headed and dizzy.
This spontaneous report as received from a pregnant pharmacist who on 08-AUG-2013, had a ZOSTAVAX spilled on her pal due to needle leakage while with-drawing a dose of ZOSTAVAX from a vial (not administered). No adverse events were reported. Additional information is not expected.
Instead of diluting the Pfizer Covid-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient; Instead of diluting the Pfizer Covid-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient; Chills really bad; real shaky; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a 15-year-old patient that, A 15-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: FC3182), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient did not have any medical conditions. The patient experienced, instead of diluting the Pfizer COVID-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient Chills really bad; real shaky. She was asking also what the effects because of this. The outcome of the events were unknown.    Follow-up attempts are completed. No further information is expected.
SECOND DOSE GIVEN TOO SOON. FIRST DOSE OF MODERNA WAS GIVEN ON 09/03/2021.
NO ADVERSE EFFECTS.  PARENTS OF PATIENT REQUESTED THE MODERNA BOOSTER FOR THEIR DAUGHTER.  AT THE VACCINATIONTABLE IT WAS AGAIN REQUESTED.  THE VACCINE WAS ORDERED BY THE VACCINATOR AND BROUGHT TO THE STATTION.  THE VACCINATOR ADMINISTERED THE VACCINE.  AFTER THE ADMINISTATION, SHE REALIZED HER ERROR. AND REPORTED IT TO THE SITE LEAD.
This spontaneous report as received from a consumer refers to her currently 24 year old daughter with "seecor" and amoxicillin allergy. On 07-NOV-2006, the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not provided). On 15-JAN-2007, the patient was vaccinated with the second dose of GARDASIL (lot#, dose and route not provided) and on 17-MAY-2007, she received the third dose of GARDASIL (lot#, dose and route not provided). It was reported that the patient received all three doses of GARDASIL, beginning at age 17. The consumer reported that her daughter had experienced "questionable" and "inconclusive" pap smears "for the past several years", she had annual pap smears. She noted that her daughter's physician was planning to begin treating her daughter for "pre-cancer" if the next pap smear came back as "inconclusive". The consumer also added that her daughter also experienced endometriosis, but she had a successful pregnancy and delivery and currently was the mother of a four-year old daughter. The consumer expressed concern regarding the recent recall of GARDASIL and inquired if the recalled lot could had affected her daughter. The patient was not given any treatment for the events. The patient sought medical attention. At the time of the report, the outcome of the pre-cancer and endometriosis was unknown. Upon internal review, pre-cancer was considered as medically significant. This is one of two reports received from the same source. Additional information has been requested.
Pt began with hot ears, itching on trunk within 15 min after receiving vaccine.  States this happens with a lot of medications Symptoms progressed resulting in transport to ED
Pt. received Tdap and MENACTRA and was fine. Given HPV shortly after pt. yawned and said she felt dizzy. Color became pale. Pt. diaphoretic. Cool cloth to back. Pt. did start steps with legs then moved to exam table to lay down. Legs elevated. Offer water. Talking the whole time. Pulse is steady and strong. Pt. observed for 20 min. Changed position to sitting for a few minutes then to standing without complications. Declined lightheadedness lips are pink. No longer diaphoretic. Pt. released with grandmother.
rash; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, nine days after receiving the vaccine the patient experienced the event rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event rash was unknown.
Felt bad all over.  Woke up Tuesday, 8th, sweating, dizzy, faint.  CAlled 911.  They were concerned about heart.  spent 36 hours in hospital, many tests.  Sent home no findings, but left arm still badly swollen, red and hot.  Hospital did nothing about the arm.  Still feels sick and very tired
Patient discomfort started when mom was changing his diaper. Patient started to cry uncontrollably and crunch up into fetal position but on his side. Mom tried to help patient straighten up and he kept crying in pain with grunting and turning red. Then an hour later of being curled up and crying, mom feed him soon after patient vomited. Two hours later of crying and being curled up on his right side he was feed once again then vomited. This event happen 1 other time. When mother called doctor she said this was not related to vaccine.
Pt presented to office with erythema & ederma @ below the sight of the injection, pt also developed fevers for 2 days post injection- treatment was BENADRYL & TYLENOL/IBUPROFEN & ice to site.
Sent home from school 12/10/02 with chicken pox. Seen by MD 12/19/02: lesions mainly on scalp, face and trunk. Use Benadryl and caladryl lotion.
Nausea - 30 minutes chills - 12 hours Sweating &  hot flashes - 12 hours Fever - 101.2 (highest point) 2 hours Tightness in chest - 30 minutes
Upper thigh swelling on the side of injection (left leg), occurring after 3rd dose of dTap, patient is on a catch-up schedule. No fever, no pain,  + pruritus, seen by physician on 6/6/2016.
Pt fainted immediately after receiving vaccine. Regained consciousness after 15-20 seconds. Got patient to floor and feet elevated. Monitored blood pressure until it returned to normal.
1st dose:  dizziness and arm rash second week after the shot 2nd dose:  fever (102 degrees); migraine; severe aches; dizziness; and arm rash within an hour of the shot. Fever, migraine and aches finished within 48 hours, but the dizziness and rash persisted beyond that.
This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a 76-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017). The patient's past medical history included stroke (experienced in 1980 and took anticoagulants). Concurrent medical conditions included renal stone (too large to pass and the patient was placed on antibiotics), urinary tract infection (white blood count was very high) and walker user. On 7th November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th November 2016, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant), weakness (serious criteria hospitalization) and balance disorder (serious criteria hospitalization). On an unknown date, the outcome of the Guillain Barre syndrome, weakness and balance disorder were not recovered/not resolved. The reporter considered the Guillain Barre syndrome, weakness and balance disorder to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by the patient's daughter. Concomitant medication included anticoagulants. On 5th November 2016, the patient was admitted to the hospital and was diagnosed with a kidney stone and a urinary tract infection (UTI). She was placed on a large dose of antibiotics and a stent was put in. The patient remained in the hospital until 10th November 2016. When the patient was released from the hospital, she went to a rehab facility. She at first felt off balance and weaker and eventually needed an aid's assistance to walk. As a result of her stroke in 1980, the patient occasionally used a walker in public but was able to drive and walk around in her house. The patient told the aids at the rehab center that she needed to go to the hospital. On 13th November 2016, the patient was admitted to hospital and she stayed until 27th November 2016. While in the hospital for the 2nd time, a number of procedures including a lumbar puncture were performed to try and determine why the patient was unable to walk and becoming weaker. She was diagnosed with Guillain Barre. At the time of reporting, the patient was in a rehab center. The reporter had a form that stated the information was reported on behalf of a nurse but she was not sure this is the same nurse who administered the vaccine. This case might be legally significant as the patient's daughter seemed to be more upset at the facility for administering the vaccine when the patient was already fighting with the infection.
The evening of receiving the vaccine every muscle and joint in my body was achy, started feeling anxious and depressed, just to the point that I could not leave my bed for a week, extreme fatigued.  I feel a little better, started making myself get up and do stuff and went back to work on 01/11/2021.
given half-dose for the 2nd dose (primary series); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given half-dose for the 2nd dose (primary series)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (given half-dose for the 2nd dose (primary series)). At the time of the report, ACCIDENTAL UNDERDOSE (given half-dose for the 2nd dose (primary series)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  It was reported that they looked at the CDC's recommendation but the patient cannot come back today until Monday or Tuesday. They want to know if there is any additional information to the CDC's recommendation or if this has been reported.
Patient received his first dose of the moderna covid vaccine 5/25/21. He came to the pharmacy today saying he still feels ill from it. He stated he does not have a fever but he has body aches and his eyes burn. The burning of the eyes doesn't last long but it happens a few times throughout the day. I suggested that when the time came to get his second dose that he should see how he is feeling and let us know to discuss it before administering and that if he doesn't feel better in a few days to make an appointment with his doctor.
Pt recvd 1st dose of Hep B vax on 4JAN91 & 3 days later exp malaise, nausea, diarrhea, & low grade fever; On 4th day following vax GI sx resolved exp neck & arm pain & lymph nodes of neck & mandible area were tender; pt seen by MD;
pt recv vax 16AUG97 & on 9SEP97 pt exp a rash that consisted of 10 to 20 lesions;
lip and skin itching Narrative:  Required emergency room visit at outside hospital - was treated for allergic reaction. Per treating PA no signs of anaphylaxis or angioedema.
Pt. received HD flu shot at approx. 3pm 10/9. That evening she noticed swelling/redness at site. Site was covered w/ band aid. Band aid not removed until a.m. of 10/11. Site still swollen, red that evening.
I started feeling strange. I wasn't dizzy but I began to feel different or strange. My head felt funny & when I woke up I was staggering and I noticed my balance was off. I started throwing up & I got very dizzy so I called a friend who came and took me to ER.
Area of Lt arm, red tender and hot. Measures 90x80 millimeters - Area involved is slightly below the injection site
This spontaneous report was received from an office manager and refers to a 23 year old male patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date in August 2014, the patient was vaccinated with GARDASIL for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date in March 2018, the patient received one dose of GARDASIL 9. No adverse effects were reported.
I received the second dose of my Moderna shot series in February of 2021. I noticed lymph node swelling in my right armpit the day after the shot. Within one week, I noticed an oily blackish green substance coming out of my right nipple. I read that it was not advised to get a manmogram until 4-6 weeks after a COVID-19 vaccine, so I waited until April of 2021 to go to the doctor (OB/GYN). The doctor did not know why I was having the discharge and recommended a mammogram to rule out a more concerning cause. The mammogram showed debris in my right milk duct and a biopsy was completed. The biopsy showed nothing of concern and I was told it would just go away. The discharge continued without change. I was told by my OB/GYN that I would need to see a surgeon since the discharge never resolved.  My milk ducts were removed by a general surgeon in July 2021. No malignancies were noted, only normal breast changes and debris.
on day 7 post vaccine I developed a large lump in my upper left arm. It was red and hot to the touch, Itchy about the diameter of a baseball by evening about the size of a softball Day 8 the lump grew bigger and the redness started to spread and get more red, very hot to the touch and caused a burning sensation in my arm. On this day I saw a Dr at an urgent care clinic and it measured 9cm Day 9 again redness kept spreading almost to 12 cm, still hot to the touch and burning sensation., by then I had been treating with Benadryl every four hours for 24 hrs. Day 10 spread even more going down my arm almost to my elbow. Still hot to the touch but no longer burning. Still treating with Benaydryl Day 11 redness finally going away, lump almost gone, feels warm to touch and almost like a bruise if pressed Mild soreness Day 12, almost gone mild redness remains, no burning but still mildly warm to the touch. Still taking Benadryl at night.
This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
mouth tingling; swelling of tongue with her mouth and lips feeling numb and thick; swelling of tongue with her mouth and lips feeling numb and thick; swelling of tongue with her mouth and lips feeling numb and thick; light headed; couldn't swallow; numbness; then inside of my mouth and my tongue they started to swell; everything felt very sick like inside in my mouth, everything just felt like moving very slowly; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).    A 28-years-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), (at age of 28-years-old) via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient reported adverse reactions for her first dose of Pfizer covid vaccine received on 01Apr2021 and states immediately (after about one minute) after receiving the shot, she experienced mouth tingling, swelling of tongue with her mouth and lips feeling numb and thick. She also experienced dizziness which took rest of day for it to wear off. Customer stated that she had reactions when she got vaccine, the first dose about one minute after she got the shot, the back of her mouth started to tingle, then inside of her mouth and her tongue they started to swell, her mouth was going numb, her lips were going numb, she felt very lightheaded. she couldn't swallow and everything felt very sick like inside in her mouth, everything just felt like moving very slowly, when she woke up next morning everything was fine next day but throughout the day it slowly wore off, she just wants to know if she should be getting the second dose after having those reactions and stated to note on there she had numbness on there. The outcome of the events was unknown.   No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.
Intense nerve pain in right arm (arm of injection site), 45 minutes after receiving second dose.  Two days later, there is still tingling in hands and feet, shooting nerve pain in jaw, and random sparks of pain throughout body.
Two hours after the injection I experienced increasing soreness in my left shoulder up through the left side of my neck and down through the forearm. I became slightly nauseous through that evening. The pain and tightness got to the point I could not perform regular functions with the left arm. It felt as if my muscles were tearing and prevented me from sleeping. I took ibuprofen in addition to alternating ice and heat to no avail. It hurt to lift my arm, grip to pull or push even a blanket. This continued for 48 hours before there was slight relief. Full range of motion returned four days after the injection. For brief periods throughout the days following, I also experienced occasional slight heart palpitations.
Per RN, "Patient here with worker group to receive 1st moderna COVID vaccination. Patient received vaccination approx 1436. At 1446 patient had complaint of dry lips and statement that he has allergy to something but unable to recall. Pulled patient to recliner chair and using interpreter asked about symptoms further. He then stated that his throat was feeling like it was tightening up and swelling. At 1448 administered emergency epi pen dose to right outer thigh. Patient was then rolled into building and presented to the emergency department for evaluation. Within couple minutes of the epi shot, he stated that he was starting to feel better. That statement was as we were rolling down the hall towards the ED."  Patient taken to the ER to e seen from 1450-1620. RN in the ED, notes throat and mouth dryness while in the ED.  Patient was monitored without complication and discharged home with employer representative.
On 3/2/00, the pt developed a small red bump at the site of injection and several red bumps on his back. He has never had chickenpox.
pt had rash duration of 14 days per mother, less than 50 pox on complete body. no fever; seen by doctor no complications or medicine given;transmission is unk;
Initial health authority (NO-NOMAADVRE-FHI-2010-10087b) received on 12 Mar 2010. This patient with medical history of eczema to sun, was vaccinated with influenza virus vaccine (manufacturer unknown) on 01 Nov 2008. The patient presented with Sjogren's syndrome and systemic sclerosis on 15 Nov 2008. The patient also presented with listlessness, pain in forearm and swelling of hand after one month of vaccination. Debut of specific symptoms was relatively acute after vaccination. Final outcome of the events was reported as condition unchanged. Health authority causality was reported as possible.
Headache, sore throat, body aches, blurred vision, slurred/slow speech, nausea, hypertension.