chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I contracted Covid-19; I contracted Covid-19; I was very, very ill and kind of; kind of bedridden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Lot number: EL3247), in arm, as dose 2, single (Lot number: EL3247), in arm and as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "I contracted Covid-19"; ILLNESS (non-serious), outcome "recovering", described as "I was very, very ill and kind of"; BEDRIDDEN (non-serious), outcome "recovering", described as "kind of bedridden". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I tested positive on Sunday. Therapeutic measures were taken as a result of drug ineffective, covid-19, illness, bedridden.  Clinical course: Consumer stated, he contracted Covid-19, he tested positive on Sunday and he just reported, he was very, very ill and kind of bedridden so he was reporting now when he was well enough to call, so Sunday when he tested positive. Treatment for adverse event was just Tylenol.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she gave quadracel to an 8 year old by mistake, and not the prescribed TDap and Polio vaccinations with no reported adverse event; Initial information regarding this unsolicited valid non-serious case.  This case involves a 8 years old male patient who experienced she gave DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number: C5763AA and expiration date: 26-Aug-2022) at a dose of 0.5 ml via intramuscular route in the left arm to the patient by mistake, and not the prescribed tdap and polio vaccinations (wrong product administered) for prophylactic vaccination.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was an actual medication error due to wrong drug administered (latency: same day).  At the time of reporting, the patient had no adverse event.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recvd measles vax 26MAR91 & it was later discovered that pt was pregnant; LMP 5APR91; On 26JUN91 pt spontaneously aborted;
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Additional Details: pt parent reported child was feeling faint and dizzy, and threw up in bathroom after drinking gatorade. paramedics were called and cleared child to go home.
A few days after receiving the vaccination, I had 3 days of right sided chest pain and heart palpitations. This chest pain was intermittent, 3/10 in severity, and felt like a ?pulsing? sensation. I was not evaluated by a health care provider for this as it has already passed.
Wrist pain started 2 days after injection. Unable to touch hand or wrist  until 5 days after injection. Pain level currently  rated at 6/10 with wrist  flexion after taking anti inflammatory medication  ( 5 days after his injections. )
Information has been received from a physician concerning an 18 month old male patient with gastro esophageal reflux and dermatitis atopic who on 17-SEP-2008 was vaccinated with a dose of VARIVAX (Merck) (lot# 661540/1015X) 0.5ml subcutaneously. On 26-MAR-2009 the patient developed chicken pox. Patient sought medical attention via an office visit. No lab diagnostic studies performed. At the time of this report the patient was still recovering. Additional information has been requested.
A week after receiving my first COVID19 Moderna vaccine shot, my right arm became sore, had a red patch around the injection site, and was very hot around the injection site. I contacted Dr. with a concern that I might have an infection. Via telehealth, Dr. determined that I did indeed have cellulitis at the injection site and prescribed Clindamycin. After completing the full course of antibiotics, the issue was resolved.  Four weeks later, I received my second dose of the COVID19 Moderna vaccine in my left arm and had no adverse reaction.
Red skin, warm, hard, slightly painful, approx 5 inches diameter. Applied ice packs, resolving 10 days out
WHILE I WAS ADMINISTERING THE FLU VACCINE, THE PATIENT MOVED HER ARM AND THE NEEDLE CAME OUT OF HER.  THE VACCINE SPILLED EVERY WHERE AND WAS NOT INJECTED INTO THE PATIENT. BECAUSE THE PATEINT MOVED SO QUICKLY, SHE SCRAPED HER ARM ACROSS THE NEEDLE TIP. SO THERE WAS A SCRATCH MARK LEFT ON HER ARM BY THE NEEDLE.
Persistent pain no relief frozen sholder limited movememt had cortisone shot to no relief had pt treatment to no relief still in constant pain very much restless nights.
MA gave kinrix & Prevnar to a 15mth  child instead of DTAP & Prevnar. Provider called mom and notify of wrong vaccine administer and advise her to monitor for soreness or redness at the site. Advise mom to bring child if symptoms or concerns occur. As per mom child doing ok, denies any adverse effects at the time.
Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who experienced patient who received vaccine QUADRACEL (lot number not reported) via unknown route in unknown administration site on an unspecified date. The patient's medical history not reported and no any concomitant medications received at the time of vaccination. It was an actual medication error case due to inappropriate age at vaccine administration. It was reported that the patient was given a QUADRACEL vaccination and she is only 2 months old. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
A patient may have received an additional dose of the Moderna covid vaccine during administration. She was notified immediately and educated that she may experience more intense side effects from the vaccine. She experienced the common vaccine side effects, including sore arm, which resolved.
By 11:00pm the same day of the vaccine 4/30/21, I became achy throughout my body and just an overall feeling that I needed to lay down and rest. Also my blood sugar has been elevated even though I barely ate on Saturday 5/1/21 and still elevated today 5/2/21. I wear an insulin pump and I have had to make adjustments on the pump and have barely eaten and blood sugar still elevated and not normal for me. I was not experiencing the elevated blood sugar until after I was given the Moderna Covid 19 shot.
Mother dx with zoster 2 weeks previous to child's symptoms. 3 siblings also have symptoms.
6/21/11 4pm received Hep A shot in office 10pm - started w/tightening/swelling of lips and throat. 6/22/11 4AM -administered BENADRYL for rash on face difficulty breathing, swallowing - fever 101.8 - lips swollen. 6/22/11 10:00AM visit to doctor office, rash on forehead and face "still felt throat swollen". CBC done, pulse ox done, started on prednisone 20mg tablet 3 tablets once daily x 4 days.
The vaccine put me through the ringer; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: The vaccine put me through the ringer). The outcome of the discomfort was not reported.   It was not reported if the reporter considered the discomfort to be related to Shingles vaccine.     It was not reported if the company considered the discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-FEB-2023 This case was reported by the patient via interactive digital media. The patient stated that no more needles. Follow-up would not possible as no contact details were available.
About 40 minutes after the vaccination, my patient developed tachycardia with routine movement and ambulation along with lightheadedness. Heart Rate would go from 78-118.
This case was reported by a other health professional via other manufacturer and described the occurrence of injection site swelling in a 71-year-old female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). Previously administered products included Influenza vaccine (no adverse reaction). On 4th October 2016, the patient received FLULAVAL QUADRIVALENT. On 4th October 2016, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with TYLENOL and medication unknown (Ice Pack (NOS)). On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to FLULAVAL QUADRIVALENT.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not have any allergies. Each was given 0.5cc; the younger patient was vaccinated in the left arm while the older female patient was vaccinated in her right arm. As per the reporter, they had experienced a large orange size, red knot at the injection site and it was seemed to be immediately after the vaccination. The patients were also experienced pain at the injection site. The reporter did for each of the patients was put ice on the injection site as well as giving TYLENOL to each. Now the patient was fine and no medical attention was required. This was 1 of the 2 cases reported by the same reporter.
Patient was mistakenly vaccinated with first dose Moderna at age 17. Second dose Moderna was administered per CDC guidelines. No adverse events reported to vaccination staff.
Pt had a ground level fall and was found to have an L4 superior compression fracture.  The pt was tested for COVID on admission in case of needing operative care, and was found to be positive.
TC FROM PT: HAS RT SHOULDER AND NECK PAIN SINCE 5-2-21.  VERY PAINFUL TO MOVE ARM. HAS MISSED WORK AND GONE TO ER. ADVISED TO CALL PCP AND REPORT TO CDC.
Information has been received from a physician concerning an 18 year old female with no medical history or drugs allergies who on 13-JUL-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661954/1496X), intramuscularly. There was no concomitant medication. On 17-AUG-2009 the patient developed joint pain and muscle pain. The patient was evaluated in the office on 19-AUG-2009 and was complaining of myalgia of the upper extremities and arthralgia of bilateral elbows and knees. The physician stated she has ordered unspecified blood tests. At the time of this report the patient had not recovered. Follow up information received on 21-AUG-2009 from the physician indicated that the patient received a first dose of GARDASIL on 10-JUN-2009. She received a second dose of GARDASIL on 13-JUL-2009 (lot # 661954/1496X). The physician also reported that the patient had laboratory testing done on 14-AUG-2009 and her Rh factor, electrolytes, sedimentation rate and serum antinuclear antibodies test were all within normal limits and therefore did not warrant further investigation for RA. The health care professional contact during telephone follow-up could not supply the following information: patient name, lot number for the first dose and recovery status. Additional information has been requested.
Developed blisters along the the edge of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE BLISTERING (Developed blisters along the the edge of the tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included SODIUM BICARBONATE, SODIUM CHLORIDE (NEILMED SINUS RINSE) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE BLISTERING (Developed blisters along the the edge of the tongue). At the time of the report, TONGUE BLISTERING (Developed blisters along the the edge of the tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included salt water and used oral gel. No medical history was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional information was received and processed with initial report. Reporter Contact details were updated. Patient details were updated
pt recvd vax; 8aug95 devel fever & a few lesions on lower extremities;by 15aug95 devel 50 gen vesicular lesions;pt was seen by MD who thought lesions were flea bites;f/u: lesions resolved  p/ family's pet dog was removed from home;pt fine
>24 hours after administration of DTaP entire anterior thigh and knee swelled up and felt painful.  No limping, fever, trouble breathing.
Sharp pain at injection area that is ongoing and when I raise my are or grab  my shoulder hurts
I had heart palpitations so badly with the second dose I couldnt drink coffee for 3 days and Im a regular caffeine drinker. Ive also had ringing in my ears as of late. Strong ringing. Im 32, almost 33, with no prior health conditions and I get my blood checked regularly. I felt fie after the 1st dose but after the 2nd dose and 2 weeks later, almost 3 weeks, the ringing in my ears wont stop. It?s never happened to me before and I never had ear infections or anything in the past. I cleaned my ears recently and am sure I dont have an infection. It feels a little like vertigo. Off balance and ears are ringing.
Pt recvd Td/MMR on 13MAR92 beginning 20MAR92 feeling achy on 22MAR92 weak & hurtin all over; lt side of body w/swollen clavicular lymph nodes & ax node; elevated temp, chills;
tough time; fever of 99-101 degrees F for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (tough time) and PYREXIA (fever of 99-101 degrees F for 2 days) in a 62-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (tough time) and PYREXIA (fever of 99-101 degrees F for 2 days). At the time of the report, MALAISE (tough time) outcome was unknown and PYREXIA (fever of 99-101 degrees F for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-101 (High) Fever of 99-101 degrees F.         Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-404687 (Patient Link).
Patient's wife reported that patient had experienced nausea, diarrhea, chills, and aches since the vaccine was administered (2 days). They entered to follow up with primary care provider
Tightness/squeezing's sensation in both arms occurring around a minute after injection VS 125/76 mm hg, 90 bpm, 96% RA No CP, SOB, pruritis, hives abdominal pain or diaphoresis. Heart lungs clear to auscultation, no oropharyngeal/lip/face/tongue swelling, no hives, no stridor. No significant PMH, no allergies Resolved by 13:13 without intervention, no meds given Pt advised to seek immediate evaluation if symptoms returns or if developing CP or SOB
pt recv vax; fever, site hot to touch/swollen; tx: ice compresses/ apap;
Six hours after injection developed severe chills, muscle pain, nausea and headache. Lasted through the night.
Right deltoid discoloration, swelling, tenderness 7/10 pain, right bicep twitching intermittently every 10 mins. Tingling sensation radiates distally into from right deltoid down into right wrist.
Case number PHEH2016US022698 is an initial spontaneous report received from healthcare professional on 23 Aug 2016. This report refers to a 30 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901) 0.5 ml intramuscular on 12 Aug 2016 which was temperature excursion of 30 Fahrenheit for unknown amount of time. It was reported that, the vaccine was not frozen. No adverse event was reported following this medication error (incorrect storage of drug).
1 hour after got dizzy, slowly developed headache, body aches, fatigue, drank lots of liquids, peaked 5 hours later and gone within 36 hours;  3 days later a mosquito bite like swelling developed at injection site and slowly spread.  Day 12 stopped growing but now day 15 not begun to fade.  Not circular in shape but it looks like a few very large mosquito bites blended together.  It mostly itches mildly and sometimes hurts a bit.
Demyelination - numbness and tingling from the breastbone down hips and pelvis into both legs all the way down to feet - pins and needles. Extreme fatigue, visual changes. Increase in migraine headaches - IV Prednisolone 3000 mg ---> home taper dose.
Around 7 pm I began feeling unwell (about 8 hours after the vaccine was administered). I awoke around 3am with Severe chills, nausea, headache, and body aches, fever of 100.1. This lasted about 18 hours. It was ifficult to get any food or liquids down during that time due to painful nausea. The following 24 hours most of the above symptoms had subsided, maybe a bit of a temp coming and going throughout the day, I did feel extreme fatigue the second day. I spent a total of two days completely bedridden, unable to work or even care for myself.  Today, which is day 3, all symptoms are gone except fatigue, but I am able to do some work from home today.
Stomach pain, Nausea, Dizziness, Confusion, Headaches, Earache, Sore throat.
The swelling at the point of injection was the size of about a half of a golf ball. It was also itchy at injection site. The pain progressed across my arm, back, and eventually entire body. I also experienced fatigue and chills. This all lasted over 2-3 days.
Twitching in left arm of shot in the lower part of arm by elbow crease. Almost constant when resting. Not when moving. Thought it had stopped yesterday afternoon but then woke up this morning with the twitching. Very localized.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient had a big red circle down her arm, not where we injected her vaccine. It itched and burned. Patient had diarrhea and nausea and also had blisters in her mouth
Pt sunburned when attempting to "dry out" vaccine site 12 cm blister.
patient states that he was feeling well until Sunday January 2, 2022.  He states he suddenly developed acute onset right leg weakness when he was walking around 5:30 PM on Sunday.  His symptoms improved after approximately 3 minutes.  He then experienced the same symptoms around 9:30 PM on Sunday.  At that time he also felt his right hand was a little clumsy.  Symptoms also improved after about 15-20 minutes.  The patient reported worsening of his symptoms on Monday, January 3, 2022.  He felt his right leg was getting weaker again.  He also felt his right hand slightly weak or clumsy. He was dragging his right foot when he walked.
one dose on 2020, 2nd still not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix in 2020. Till the time of reporting, the patient never received second dose, which led to incomplete course of vaccination. Consent to follow up was granted.
Mother reported that site looked like a mosquito bite and a little red the day before and by 7:00 PM it had swelled, it is size of baseball this AM and taking her to clinic, no temp reported.
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate  first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
Information has been received from a medical assistant referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date patient was vaccinated with GARDASIL (strength, dose, route, lot# and expiration date were not reported). On an unknown date the patient experienced an unspecified reaction following administration of GARDASIL. Outcome of the event was unknown. Causality assessment was not reported. This is one of two reports received from the same reporter. Additional information is not expected as the physician is not allowed to be contacted.