chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided; accidentally been given PEDVAXHIB vaccine that was diluted; diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering it; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-SEP-2022, the patient was vaccinated with a second dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # W002453, expiration date 24-JUN-2024 for prophylaxis. The vaccine was accidentally diluted with 0.5mL of sodium chloride (NORMAL SALINE) and then 0.5mL was drawn up and administered (exact dose, route of administration, and anatomical location were not reported) (Product preparation error, Incorrect dose administered). No additional adverse event information provided (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA008125:02252011 US-009507513-2209USA008037:02251970 US-009507513-2209USA007893:02252094 US-009507513-2209USA007924:02252047 US-009507513-2209USA008290:02252078 US-009507513-2209USA008058:02252037 US-009507513-2209USA008275:02251979 US-009507513-2209USA008249:02251904 US-009507513-2209USA008273:02251935 US-009507513-2209USA007891:02251607
COLD SYMPTOMS, INFECTED GUMS, PARONYCHIA, DEVELOPED SEVERE COLD SYMPTOMS 12/30/2015.  IMMUNE SYSTEM COMPROMISED.
Tinnitus and muffled hearing which was determined to be hearing loss, not blockage, by a otolaryngologist. Tinnitus began very loudly in the the middle of the night following my second vaccine. It has persisted since and varies in volume from unnoticeable to moderately loud every day, but has not reached the same loud volume as the first night.
pt fainted for less than 30 seconds and then came to. he was diaphoretic, pale and reported a complete loss of vision. I was having a hard time getting a blood pressure and pulse was very faint. Pt was alert after fainting episode and answered all questions appropriately. 911 called for pt to be evaluated, pt declined ambulance. Father came to pick him up
Swelling and soreness  8 days after injection.  Lasted 24 hours. Redness and slight itch at site starting day 10. Lasted 24 hours.
Case number PHEH2013US020801 is an initial spontaneous report from the nurse received on 02 OCT 2013 with a follow-up received on 15 NOV 2013. This report refers to a 17-year-old female patient. Her medical history was not reported. ON 24 SEP 2013, the patient was accidentally given only MenCYW-135 liquid component of MENVEO (batch number: A11082) intramuscularly in to the left arm, and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the mal-administration. This was the second administration of MENVEO. No other information was available. Follow-up received from the nurse on 15 NOV 2013. Updated patient demographics, route and site of administration of MENVEO and batch number of MENVEO.
Severe, chronic headaches that began very soon (within days) after first vaccination of Gardasil.  Headaches became progressively worse and currently continue daily- one year later.  Referral was made for vision testing, CT Scan and MRI, with no underlying cause of headaches determined.  Numerous different prescription drugs were prescribed with no effect until current prescription, taken twice daily, was found to help subdue the headaches- though they have not been eliminated.  At their worse, the headaches were debilitating- rendering my daughter unable to function at school with some days missed and numerous visits to the nurses office and then to the doctors office.  At home, she would just curl up into a ball many days- unable to function whatsoever.  The headaches begin when she wakes in the morning and persist throughout the day- every day.  3/13/09 OV dated 12/24/07 received from PCP for 16 yr WCC. Impression:  Acne.  Sent to derm. Left SI joint pain and R lower rib tenderness.  HPV vax given. 3/16/09 Neurology consults received dated 3/14/2008 to 2/2/2009.  Initially seen 3/14/08 for c/o 8-9 wk hx of H/A. Pt reports double vision, dizziness, nausea and lightheadedness with H/A. Recent 6lb weight loss.  PE WNL. DX:  Chronic Tension H/A. Rx meds.  F/u 6/2/08 with no improvement,H/A now daily. Meds increased. F/u 8/1/08 H/A now with photophbia and nausea. 8/8/08 Mom reporting memory difficulties x several weeks. 9/2008 started Cymbalta with some improvement in H/A, however having diarrhea and tiredness.  Changed to Zoloft.
Mom claimed child had what appeared to be a seizure. She was starring into space. No fever, jerking, or eye-rolling.
swollen face; swollen lips; swelling under eyes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face), LIP SWELLING (swollen lips) and EYE SWELLING (swelling under eyes) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SWELLING FACE (swollen face), LIP SWELLING (swollen lips) and EYE SWELLING (swelling under eyes). At the time of the report, SWELLING FACE (swollen face), LIP SWELLING (swollen lips) and EYE SWELLING (swelling under eyes) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported.
A short time after receiving the immunizations patient started having bilateral redness and swelling in both legs. This started at the sites of the injections. A short time later his cries changed from normal in sound to hoarse in nature. A short time later he had hives that were spreading from the site of the injections.
At the conclusion of giving the vaccines, baby lay quietly, did not cry, had blank look on face, eyes open. No cyanosis. Mother picked baby up, he came to alertness after approx. 1-2 minutes M.D. came in, baby was laid back down, was by then looking around. Became alert again, then cried.
Patient developed facial and upper body flushing with complains of substernal chest pain approx. 20 min after vaccinations. She subsequently vomited x2. No facial swelling, shortness of breath or angioedema. She c/o diffuse itching, with flushing progressing to lower extremities with areas of blanching, but no distinct wheals (raised). Lungs CTA. Mild conjunctival injection. Pt was observed in our clinic x 4 1/2 hours. 0 mg Benadryl administered. She complained of chills for approx 45 mins. rash and Gastrointestinal symptoms subsequently resolved. BP/HR/AR remained normal.
Rash developed on the back of both calves and a welt developed in the bend of the left arm.  The rash resolved itself over the next three days.  The welt disappeared by the next morning.  Three days later I had severe gastrointestinal upset that lasted for  4 days.
Right away, He had extreme pain in his arm.  He then laid back, fainted and became convulsive.  I screamed and got the doctor down the hall and we sat him up and he started coming back but, didn't know what happened.  He then complained of jaw pain, chest pain, headache and stomach pain.  He then proceeded to vomit about 6 times.  We laid him back down for about 1/2 hour with a cold rag on his forehead.  He still does not feel well, but no symptoms since returning home last night around 5:45 PM.
sensation on forehead that turned between eyes; blood pressure went high; mental sensation on the throat/ minute 11 throat clamed down and lose air breath; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (sensation on forehead that turned between eyes), HYPERTENSION (blood pressure went high) and OROPHARYNGEAL DISCOMFORT (mental sensation on the throat/ minute 11 throat clamed down and lose air breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (IBPA) and Drug allergy (Victoza (victosa)). Concomitant products included METFORMIN, RAMIPRIL (ALTACE) and GLIPIZIDE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (sensation on forehead that turned between eyes), HYPERTENSION (blood pressure went high) and OROPHARYNGEAL DISCOMFORT (mental sensation on the throat/ minute 11 throat clamed down and lose air breath). At the time of the report, DISCOMFORT (sensation on forehead that turned between eyes), HYPERTENSION (blood pressure went high) and OROPHARYNGEAL DISCOMFORT (mental sensation on the throat/ minute 11 throat clamed down and lose air breath) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included Benadryl and peptide.
BECAME VERY ILL; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 after vaccination, the patient became very ill. The patient was hospitalized on an unspecified date, The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling very ill was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210449330--BECAME VERY ILL. This event is labeled per RSI and is therefore considered potentially related.
Patient advised they do not do well with shots. Patient was waiting after administration when they began to feel faint and alerted wife. She yelled for help. I immediately joined patient and wife. He was already conscious and aware of surroundings, alert to time and place. I retrieved mat for him to lie down on. He stated he was feeling better. After about 15 minutes the patient was feeling back to normal and was upright in a chair. He remained there for another 15 minutes at which time he felt well and comfortable returning  home with wife.
Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
Pt had red and puffy area on (R) leg that was larger than a fifty cent piece.
Patient received an extra dose of annual influenza vaccine on 12/20/2021.  Pt and family member did not recall receipt of annual influenza vaccine via Fluzone high-dose quadrivalent on 11/30/2021 during a previous office visit.  Medical assistant missed seeing record of previous dose prior to administering  extra influenza dose of Flucelvax.  Patient made aware of incident.  No adverse reaction has been reported.
Fever (101.5), body aches, headache, painful injection site w/ 5 inch circle of swelling. Symptoms decreased after 48 hours and gone at 72 hours.
Not feeling well, no temp, but had pain in back behind lungs thought maybe it was pneumonia but, tested for covid just to make sure.  It was positive.
patient reported she was fatigued after receiving the vaccine. She then began to have joint pain and she reports she was barely able to walk. She has an appt. with her MD Wednesday (joint specialist). She has been taking Advil 325mg PRN.
shot on 11/21 on 12/ 21 had terrible stomach issues of diarrhea and stomach upset with nausea. has continued since then under doctor care. shortly after started getting   headaches and   dizzy spells that were minor. in may had to call 911 because of vertigo and stomach upset  spent one day in hospital. about two weeks later i noticed a hearing loss and saw ent dr . profound hearing loss in right ear and moderate loss in right . had injections in right ear which did not help. diagnosed with sensorineural hearing loss both ears.  still have loss. cant afford the cost of hearing aids. also since 12/21 have been tired all the time continuously.
Dose 1- Low grade fever, rash (about 5 inch diameter) around injection site a week after the initial dose (symptoms began Sat night, rash on Sunday). At the time had not been hearing about the delayed rash in the arm so scheduled a doctor visit on advice of my workplace employee health to check for any cellulitis (visit was the Monday following the rash). Rash confirmed and lasted about 5 days. No fever after that first night. Dose 2- low grade fever, achiness about 12 hours after injection, smaller rash (about 2 inch diameter) developed by the next morning and faded after a couple of days
Pt recvd 2 doses of Engerix-B & exp no events following 1st dose but p/2nd dose devel fatigue, dull h/a, low grade fever, nausea, night sweats, rt arm sore & swollen; ER or MD visit required to treat events;
redness and edema to left upper thigh, front area approx 4x3" warm and tender to touch pt c/o pain/discomfort.
PT HAD BRUISES ON HER HAND AND A BIG BOIL PT COMPLAINS ITS FROM THE SHOT SHE RECEIVED.
Took 2 benedryl prior to injection- That night was awaken by severe  systemic nerve and joint pain,  neck pain and the worst headache of life. Symptoms subsided within 48 hours.   3 days later left arm swelling with mild cellulitis
Nausea, vomiting, temp 105 to E.R. & admitted to hospital - Cellulitis of arm, vomiting, jaundice.   12/29/08 MR received for DOS 11/21-24/2008 with d/C DX:  Cellulitis.  Increased liver functions.  Hx of hereditary spherocytosis. Pt presented with c/o chills, rigors, nausea, vomiting and arm pain. PE (+) for fever, dry mucous membranes, scleral icterus, and tnderness, erythema and warmth of the R upper arm.  Tx with abx. Increased LFTs likely 2' to hereditary spherocytosis. Slow improvement in pain and swelling so abx were changed and effective.
PT EXPERIENCED MUSCLE PAIN AND ACHES WITH FEVER FOR 2 WEEKS AFTER IMZ . HER INJECTION SITE WAS SORE FOR 2 WEEKS. SHE DEVELOPED SMALL RASH-LIKE BLISTERS ON HER BACK, ARMS AND LEGS. SHE REPORTED THESE TO HER MD AND THE MD SAID IT LOOKED LIKE A FORM OF CHICKEN POX. THEY WERE NOT TREATED BECAUSE THEY WERE NOT BOTHERING THE PT--NOT ITCHING , BURNING OR PAINFUL.  PT REPORTED THIS TO PHARMACIST AND AS OF A FEW DAYS AGO SHE WAS STILL DEVELOPING NEW RASHES.
When I went to work I had to leave a meeting because I was coughing so bad.  My job sent me home because they said I looked bad. The coughing got worse by Wednesday. I started having shortness of breath on Friday. I was grocery shopping and my coughing cut my breath off. I went to the hospital and they ran test on me and they came back negative. I was on oxygen since the 10/24/2022. They wouldn't let me go home because my heart rate was so high. They gave me several medications.
On 6/10/22 tested positive for Covid. Symptoms were congestion. Cough, fever, severe fatigue with hair loss. Telehealth doctor prescribed antiviral medication.
A pharmacist reported that an unidentified patient received an injection of Tetanus Toxoid 20 years ago and subsequently developed an allergic reaction. The patient recovered.
12 hours after injection, experienced fever and chills and headache which subsided after 24 hours. Three days later, experienced outbreak of hives in areas away from injection site on arm; reddish rash all over arms, legs, back, neck, and chest. They were itchy and hot. I took a normal dosage of Benadryl (25mg diphendyramine)  in the event that it may have been contact dermatitis (as this has happened to me before and Benadryl typically alleviated those symptoms when that was the case). The Benadryl did not alleviate the symptoms, but the rash cleared up on its own after three to four days.
Pain at the site and a rash that continues to this day.  Nausea, fatigue, headache on day 4 which lasted about 12 hours.
I have got my first shot, I am supposed to get the second one and I am in the hospital because I have UTI (Urinary tract Infection); My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot number was not reported) (at the age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included open heart surgery; patient fell and got 2 titanium screws in her neck and three screws in her hip; she also had got venous stasis in the leg where the blood goes down but won't go back up. The patient had a whole list of concomitant medications (unspecified). It was reported that the patient was in the hospital. She got her first shot and she was supposed to get the second one, but she was in the hospital because she has UTI (Urinary tract Infection). So, she was just asking what to do as she does not want them to come to her home since she was not there. She asked whether she would just call when she gets out of the hospital. She confirmed that it was the first dose of Pfizer covid-19 vaccine. She got the first dose of the vaccine on 07Jul2021 and was supposed to get the second one on 28Jul2021, but she was still in the hospital. When probed about the side effects, she mentioned her arms was just little sore, but no she didn't have any side effects. She just wanted to know what she should do, if she should call when she gets out of the hospital to get her second shot. She commented that she wanted to get the second shot. She added that she read in the paper she was given about smell and taste and shortness of breath, and she read all that. She added no it did not swell up. It was just in the spot where she got the injection, just was red and sore but it went away right away. No side effects. The UTI, vaccination site pain and vaccination site erythema started in Jul2021. The outcome of urinary tract infection was unknown while vaccination site pain and vaccination site erythema was recovered in Jul2021.  Information on the lot/batch number has been requested.
Exhaustion about 5 hours after the injection. Extreme cold and uncontrollable shivering and chills about 6 hours after injection for several hours throughout the night. Sometimes interrupted by sweating. Ibuprofen helped to regulate the body temperature.
Pt presented on 2/22/21 reporting right sharp and stinging arm and shoulder pain for 3-4 days. Pain was worse with touch/pressure. On 2/21/21 he developed a lesion on his shoulder.  Provider found 2 vesicular lesions concerning for shingles.  She started pt on gabapentin an valcyclovir and will follow up as needed.
Mental mouth, sore arm, Vertigo very bad weakness fever up to 101 for about 50 hours chilling sweating profusely then my soreness went down into my armpit and to the side of my boob and it got hard now after 75 hours I?m itching where this site where I had the injection finally got better about 60 hours in
Redness, mild swelling, itching, left upper arm @ 6inx6in Benadryl prn.
5FEB96 pt recv vax & 6FEB96 c/o h/a, n,dizziness;BP 150/94;? virus vs stress vs rubella;26FEB96 c/o arthritic s/s, finger tips numb;saw MD 17FEB;10FEB96 arthritis s/s;17FEB aspiration fluid by MD;29FEB96 more edema;22AUG96 arthritic pain;
Before the vaccination I had my normal menstrual cycle June 6- 11th, 2021. After my first dose I did not have my period around 28-32 days later as expected. I then took the second Covid (Pfizer) dose on June 29, 2022 and did not get my period until August 4-18, 2021 and it was 14 days long.
Vomiting, diarrhea and a really bad headache, body burning up Sharp pain in chest  Today 06/27/2021 Feeling dizzy
Information has been received from a pharmacist concerning a female patient who was vaccinated on unspecified date with PNEUMOVAX 23 vaccine. The pharmacist reported that the patient developed redness and swelling on her arm at the injection site after receiving the vaccine. The patient has sought unspecified medical attention. At the time of this report, the patient's outcome was unspecified. No further information is available.
Caught Covid/ tested positive for Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Caught Covid/ tested positive for Covid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced COVID-19 (Caught Covid/ tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Oct-2022 to 29-Oct-2022 for COVID-19, at a dose of 6 tablets per day, qd. On 09-Nov-2022, COVID-19 (Caught Covid/ tested positive for Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2022, SARS-CoV-2 test: (Positive) COVID-19 antigen test. On 31-Oct-2022, SARS-CoV-2 test: (Negative) COVID-19 antigen test. On 09-Nov-2022, SARS-CoV-2 test: (Negative) COVID-19 antigen test. In November 2022, SARS-CoV-2 test: (Positive) COVID-19 antigen test.         No concomitant medication information was provided.  The patient started developing symptoms of sinus type cold feeling with congestion on 23-Oct-2022.  It was reported that the patient was fully vaccinated with booster dose of Moderna vaccine. After taking Paxlovid on 24-Oct-2022, the patient showed rapid improvement in condition. The patient finished Paxlovid course of treatment on 29-Oct-2022. Then on 31-Oct-2022, the patient started feeling bad again. The patient had recently tested negative for COVID but was still experiencing lingering cough.  The patient took 6 tablets of Paxlovid per day. The patient had no emergency room visits.
Menactra given instead of Prevnar. No adverse reaction and no treatment needed. Child too young for MENACTRA.