chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an 80 year old male with hypertension and hypercholesterolemia, and with no known drug allergies, who on 9/6/05 at 15:00pm was vaccinated IM in the left arm with a third dose of Pneumococcal 23v polysaccharide vaccine lot 647661/0055R. There was no illness at the time of vaccination. The pt was noted to have been administered the first and second doses of Pneumococcal 23v polysaccharide vaccine in Nov 1997 and Dec 2001. Subsequently, on 9/6/05 at approximately 22:00pm, the pt experienced burning at site of injection and pain at site of injection. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a medical assistant indicated that on 9/6/05 the pt left upper arm had edema, was swollen, was warm to touch and had pain. The pt was advised to use two Benadryl every 4 hours PRN and Tylenol. He was also told to use cold compresses. There were no adverse events following prior vaccinations. The patient recovered on 9/9/05. No additional information is expected.
N17.9 - Acute kidney failure, unspecified E83.42 - Hypomagnesemia N18.9 - Chronic kidney disease N17.9 - Acute kidney injury (CMS/HCC) R53.1 - Generalized weakness
2 days post vaccine pt developed rash to cheeks, trunk and back of head, swollen glands to back of neck. Rash persists to cheeks and trunk.
Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 16-year-old male patient who received BEXSERO. Concomitant products included MENVEO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO on an unknown arm and experienced arm soreness for 2 weeks. The patient required emergency room visit. Sales rep did not have any other information.
Patient was given the pediatric formulation of the Pfizer vaccine instead of the adolescent/adult formulation in error for both doses.  She had no side effects.
Starting on the day of the vaccine, no symptoms noted.  Exactly 8 hours later at 10pm in the evening,  I got an awful cramping in my stomach. I had vomiting, diarrhea, headache and my blood pressure was 170/110.   I took my blood pressure medications.  This lasted for the next 8 days.  On day 5, I went to work at the hospital  and felt very ill. My BP was very high and I was prescibed clonidine.  I had significant weight loss, dehydration, I had to get IV fluids.   On the 8th day, all my GI symptoms resolved but my blood pressure still remained high.  The HBP remained high for another 2 months intermittently and had to dose with clonidine to bring the pressure down.
woke up this morning with a rash around the injection site, red warm and swollen about the size of 1/2 dollar
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Date of refrigeration was reported as 05 May 2021.   This case was linked to MOD-2021-365188.
Developed generalized edema from hip to knee and involving the knee with mild erythema and decreased flexion of knee joint. Slight bruising at injection site over course of 2 days.
worsening dyspnea, new back pain, patient requiring O2 to keep sats above upper 80s. COVID 19 positive Remdesivir for 5 days and dexamethasone x 10 days.
injection site redness; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   Concurrent medical conditions included drug allergy (reactions to hydrocortisone butyrate).   On 21st May 2019, the patient received Shingrix (intramuscular). On 21st May 2019, immediately after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. The patient experienced localized redness at the injection site almost immediately after receiving Shingrix. There is a discrepancy with respect to the time to onset and outcome of reported adverse event redness at the injection site. In the source document, the event onset date is reported as 24th May 2019, however as per narrative, event started almost immediately after receiving Shingrix. Similarly outcome is mentioned in source document as recovering/ resolving however in narrative it was not recovered/ not resolved. Therefore, the event onset date is retained as 21st May 2019 and time to onset as immediately and outcome as not recovered/ not resolved as per narrative description.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 40-year-old female patient who received HAVRIX. Co-suspect products included HAVRIX. On an unknown date, the patient received the 1st dose of HAVRIX (intramuscular) and the 2nd dose of HAVRIX. On 30th August 2017, unknown after receiving HAVRIX and HAVRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis A (serious criteria hospitalization) and sepsis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the hepatitis A and sepsis were recovering/resolving. It was unknown if the reporter considered the vaccination failure, hepatitis A and sepsis to be related to HAVRIX and HAVRIX. Additional details were provided as follows: The concomitant medication was unknown. The age at vaccination was not reported. In 2008, the patient received the HAVRIX vaccine series on her arm. On 30th August 2017, the patient was hospitalized for Hepatitis A and sepsis. The patient had spent 7 days in the hospital and was still recovering. The patient had to have weekly physician visits and twice a week liver function tests. This case considered to be suspected vaccination failure as the details regarding exact time to onset and lab test confirmation for hepatitis A was unknown.
Primary issue is tooth pain, not from grinding.  Lower teeth, mid molar to eye teeth.  Feels like multiple tooth ache vs gum inflammation
Lower left half lip twitching and pulsating intermittently. Lasted about approximately 2-5 mins. I could visibly see the half lip pulsating and touching it I could feel it pulsating. It's never happed before. So far it has happened once
Pt. with erythematous plaque to L deltoid posterior to injection site. No heat, no streaking, no tenderness, no s/s of infection. Pt denies pain, has FROM, only concerned regarding discoloration erythema started 1 wk after injection - likely injection is not the cause. Ice, Ibuprofen, RTC if pain or loss of ROM or increasing in size.
pt recv vax 25FEB93 & pt exp flu-like sx & muscle weakness;
This spontaneous report was received from patient's mother refers to a 12 month old patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 10-FEB-2016 (reported as yesterday), the patient was vaccinated with two 0.5 ml doses of VARIVAX (Merck), during a doctor's visit. No adverse effect was reported. Additional information has been requested.
arm hurt; she can hardly lift her arm; arm is swollen was reported as worsened; arm is swollen; itchy arm; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number& Expiry date not reported) via an unspecified route of administration, administered in Left arm on 27Mar2021 at 13:00 (at age of 66-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration in left arm on 07Mar2021 at 13:00 (at age of 66-years-old) as single dose for COVID-19 Immunisation and experienced arm is swollen and itchy arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks.Caller stated she is calling about the COVID 19 vaccine to report some adverse reactions she has experienced. Caller stated her arm is swollen, itches really bad, and is hurting. Caller stated she just had the shot on 27Mar2021, clarified as the second shot. Caller stated this started with the first vaccine on 07Mar2021 and then it just started Arm swollen and swelling on 27Mar2021 from the second dose. Caller stated this is getting worse and she can hardly lift her arm. Caller stated this first started on 07Mar2021 and experience Itchy arm. when she went back to get the second dose, she asked the public healthcare nurse if she should get the shot in the same arm and the nurse said yes. Caller stated this is ongoing and it sometimes is worse and then sometimes she does not feel it as it does not itch all the time but when it does itch it itches really bad. After second dose of vaccination patient experienced Arm hurt on 29Mar2021. Caller stated she was advised to put ice on its last night and this morning it was hurting when she woke up. Caller does not have the COVID 19 vaccine card at this time as it is in her garage. Therefore, unable to provide lot/exp/NDC from either dose. Patient did not visit any Emergency Room/Physician Office for events. Patient received treatment for arm hurt by putting ice. The Outcome of the event arm is swollen, arm hurt, hardly could lift arm was not recovered; itchy arm was unknown.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
fever. Highest temperature was 101.1 F. I took tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total; back aches/achiness were better after sleeping for the night; headache; Fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left arm on 24Dec2020 08:30 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Baseline leukopenia. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 12 hours after the vaccine the patient developed back aches, headache, and a fever. Highest temperature was 101.1 F. The patient took Tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total. Fatigue and achiness were better after sleeping for the night. Events onset date was provided as 24Dec2020 11:30 PM. No treatment was received for the events of back aches, headache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 25Dec2020 04:30, the outcome of the other events back aches, headache and fatigue was recovered on an unknown date in Dec2020.
She had her arm hurt all the time. She cannot lift the arm all the way. She claims that the 1st dose was administered close towards the elbow. Then she came for the 2nd dose and was given closer to the shoulder in the Right arm and the Right arm where she got the 2nd Dose doesn't hurt.
Was not vaccinated and went to get first shot but instead they gave me the pfizer booster fj8762.  When asked why they gave me the booster they said that was the one I needed.  Felt sick and dizzy after and then proceeded to have a rash that started a few days after.  Hands would go numb and face.  Started having seizures and now I can really do anything. Right side of face is always numb and loss of hearing in right ear.  The worst part is that doctors try to tell you that it's from brain surgery and not the vaccine.  Well it's mathematically impossible for them to give me that answer.  It is morally wrong to do what is going on.  And there is so many other that are dealing with multiple problems and issues that the medical field completely ignores.
Myalgia, SkinRash, developed skin rash over neck/left clavicle about 48 hours post vaccine; Had myalgia/fatigue about 24 hours post vaccine Narrative:
Patient and father checked in for Pfizer booster vaccine. Before administration, patient's father requested with nurse that the Moderna booster vaccine be administered instead. Administering nurse administered Moderna booster vaccine without confirming with pharmacy staff.
Nine days after vaccine I noticed the vaccination area was swollen, red, hot to touch, and there was a rash.
On Day 2 following the first dose, I started to feel light-headed and dizzy. I also have had a headache for the two weeks since the first dose. I feel brain fognot fully sharp at work and at other tasks. I'm also quite fatigued.   I noticed that a glass of wine with dinner considerably magnifies the dizziness. I've tried eliminating wine for a few days, which seems to help. But when I had a glass of wine again, the symptoms returned the following morning. I have tried vestibular exercises, which seemed to help for a few hours. But overall, the symptoms persist.
Fatigue; sore injection site and arm; sore injection site and arm; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 09Feb2021 at 17:30 (at the age of 38 years old) (Lot Number: em9809, unknown expiration) as 1st dose, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced fatigue and sore injection site and arm on 10Feb2021. No other vaccine in four weeks. The patient did not receive treatment for the events. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
Administration error. this 13 year old received a 3 dose of the COVID -19 vaccine.
10/13: Within an hour, injection site pain  & warmth. Within 8 hrs, fever, chills, h/a, cramps, back pain, fatigue, metallic taste: 10/14: fever gone. Fatigue, h/a & metallic taste persist.  Afternoon, Palate pain with vesicular eruptions. A few painful  vesicular eruptions on both hands: 10/15:  a few more eruptions on hand and expanded area of palate. Tingling hands, feet & face. Metallic taste persists: 10/16: no new eruptions. Intermittent tingling hands & feet. Metallic taste persists: 10/18: returned to Dr.'s  office. Evaluated for weakness. Told to go to er if any weakness with the tingling: 10/20: tingling resolved. Lesions flattening. Metallic taste persists.
pt recvd vax 3NOV95 & 4NOV95 high fever & gen sz;pink rash on face started 4NOV95;no fever 5NOV95;cough & runny nose started 5NOV95 w/vomiting;PE on 7NOV95 pt alert, pink mac pap
Pt devel severe tenderness, redness, & a"knot" @ the inject site p/receiving Td; warm soaks were applied for several days to treat this rxn;
Intense itching (pruritis) of hands, red rash on palms, swelling of right hand, swelling of lip. Two days later, on 6/18/2014 hives and diarrhea develop.
Patient was a resident of a Health Center.  Patient tested positive for Covid-19 on 02/04/2022 at facility.  Ordering provider: Dr.  Patient expired on  02/11/2022.
Breathing difficulties, acute coughing attacks, irritated throat, wheezing and itching (first couple of weeks) Zirtec + inhalation aerosol
FREE MOVING NODULE NOTED ABOVE DISTAL PORTION OF LEFT CLAVICLE.  NO HISTORY OF SAME.  NOT PAINFUL. NO FEVER.  MINOR LEFT UPPER ARM SORENESS NOTED.
~3 hours post vaccination, pt experienced headache and extreme chills. Symptoms progressed into inability to walk, loss of urinary control, odorous urine production, delirium, insomnia, extreme dreams. These symptoms lasted about 48 hours. Even post 48 hours pt is still experience malaise.
05/13/05- vesicular rash- back, trunk increasing in quantaty ov 48 hour period. Sibling DX with Varicella 2 weeks previous to this childs onset. Follow up: Additional vaccine given on same day: 1/7/99 inadvertently omitted from report. Varicella 0667W exp 10/22/99, given Rt thigh. If further info needed feel free to contact us.
Pt cc: nausea and dizziness. Pt blood pressure: was 124/78. Pt cc no further after drinking water. Patient ate this am. Patient was able to leave by self.
She got her vaccine, she had no reactions at all.  On the 4th day 3/13/21, had a blister on the inside of her right nose that had clear fluid for it.  She went to the doctor for this and he popped the blister to get it to drain.  It drained on the outside of her nose and down to the back of her throat which caused a burning sensation in the back of her throat and a nasty metal taste in her mouth.  it also caused her voice to change.  This has been going on ever since this occurred.  She has been to a couple of ENT providers for this, the first one put her on steroids which didn't change anything.  After that her regular physician ordered a CAT scan and sent to a Dr. who is now treating her.  he has her doing a sinus flush with salt water right now, and he is having a special medication made.  He feels that there is a problem and that there is a possibility that her brain fluid is leaking out.   A couple of days after that she got a cyst under the right breast and she thought it was a pimple and it continued to grow and she went to the ER as it was very painful.  She was put in Clindamycin and told to put warm compresses on it, and to watch it.  It did pop open and it oozed, and they sent her to see a surgeon for the breast lesion as it is very large now.  He went in a made a small incision and opened the wound up for drainage and put packing in it, which is still ongoing and still undergoing treatment for that.  He put her on more Clindamycin and pain medications, Hydrocodone.   All of her doctors have told her not to take the 2nd vaccine.
Received first dose of Moderna vaccine in left deltoid. went to car with family and began vomiting. No SOB with chest issues. Called 911. Gave one aspirin per 911 call. Pulse  in normal limits. Patient did not get transported to ED via ambulance.
Pain (scale 9), muscle spasms radiating from injection site, burning at injection site, Hydromorphone, muscle relaxer (unknown), prednisone, APAP, unknown diagnosis.
1/13/10 Mother called in to report that student had reaction to H1N1 vaccine. States student had red bumpy area size of orange at injection site. States student felt "feverish" although mother did not take temperature. Student MD notified by mother.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-SEP-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-APR-2013, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Developed redness, induration and tenderness around vaccination site in left thigh. Looks like cellulitis - treated with antibiotics. No fever.
within the minutes it took to walk to parking lot, Vaccine recipient noticed symptoms in line with anaphylaxis such as: diminished ability to breathe regularly / ?get a full breath? After 5 minutes driving from pharmacy to home, this symptom continually increased in severity. Approximately 15-25 minutes after receiving the dose a nauseated feeling (likened to being ?intoxicated?) was noticed. Increased feeling of fatigue/exhaustion. Difficulty maintaining sense of balance. slight adverse sensation to light. Patients family was ?very close to contacting EMS.?
I hadn?t had a sick day in over a decade? I was never sick. Now I get fevers every 4 months & am sick with a cold every 2 months. These companies robbed me of my health.
The next morning after the vaccine I woke up with severe GI issues: nausea, vomiting and diarrhea which persisted for about 2 days by day 3 it got no better so I reached out to my PCP who prescribed Ondansetron to help with the nausea. I took Pepto-Bismol to help with the Diarrhea all of which lasted about 1 week.
Patient complained of feeling flushed: did not appear flushed. Complained of difficulty breathing. Observed by RN at site. Patient given Lorazepam 0.25 mg orally. Patient exhibited increasing shortness of breath with puffy eyes. Doctor called. Pt given epinephrine 0.3cLx1 at 2PM. 2:15 patient transported to Emergency Department by ambulance. No interventions at hospital ED. Pt recovered by time of arrival. Diagnosis: possible reaction to flu shot vs. anxiety.
LOCALIZED REDNESS SWELLING AT INJECTION SITE. TINGLING IN FINGERS