chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High fever started 10 hours after shot lasted for 24 hours. 102-104.7  fever above 104 for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in left arm on 19Aug2021 12:00 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. Medical history included allergies and asthma from an unknown date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration in left arm, on 29Jul2021 17: 30 (at the age of 12-year-old), as single dose for COVID-19 immunization. Patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEK) and fluticasone propionate (FLONASE ALLERGY RELIEF) both taken for an unspecified indication. Prior vaccination, patient was not diagnosed with COVID and did not receive other vaccine in four weeks. On 19Aug2021 22:00, the patient experienced high fever which started 10 hours after the shot, temperature was 102-104.7, where temperature was above 104 for 4 hours. The fever lasted for 24 hours. The event resulted in doctor's office visit/urgent care.. The patient was not tested COVID since vaccination. Therapeutic measures in response to the event included, alternate use of Ibuprofen 800 mg and Aspirin 600 mg. The outcome of the event was recovered on 20Aug2021 22: 00.  Follow-up attempts are completed. No further information is expected.
Shot was given at 4:00pm on a Tuesday. That evening around 9:00pm patient was nauseas. Went to bed and couldn't sleep because entire body hurt. Vomited at 9:00am the next day(Wednesday) and had a fever 101.3F, chills, muscle pain on entire body and a headache. Called into work and laid in bed all day. Heart rate was 120bpm (typically it is around 70bmp). Took Tylenol which brought the fever down at 5:00pm. Finally was able to eat something. Took more Tylenol before bed and was able to sleep. Woke up Thursday and still felt achy but functional with a headache and nausea. Same symptoms minus the nausea on Friday.
pt recv vax 28FEB96 9AM  in the rt arm & 2hr later vomited 3x;pt also had a h/a & a stiff neck;pt reports the sx have become worse;pt was adm to ER on IV & was treated w/phenergan;
"The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer."
Pt was given PNEUMOVAX in left deltoid & FLUZONE HD in right deltoid on 9/14/12. Called pharmacy 9/16/12 saying she had developed tenderness under the armpit & arm broke out in a rash extending to armpit on left arm.
3 1/2 days of moderate-severe redness and tenderness. Starting an inch below sight and stopping 8 inches below by 3-4 inches wide. Hot to the touch.
This report was received from a health professional on 01 July 2008. A 39-year-old female patient received her second intramuscular right deltoid injection of IMOVAX RABIES (lot number A0484) on 17 June 2008. Past medical history included increased cholesterol, fibrocystic breast disease, degenerative arthritis, and allergic conjunctivitis. Previously, she had received an intramuscular gluteal injection of IMOGAM (lot number B0886-5) and a first injection of IMOVAX; dates of administration were not provided. Following her second dose of IMOVAX, the patient began experiencing swelling in her hands and feet. She developed a red, blotchy, raised, itchy rash which was generalized over her entire body. The right deltoid was hot to the touch at the injection site. She subsequently complained of generalized body aches, and numbness in her hands "as if they were falling asleep". No relevant laboratory test results were available, and outcome was unknown to the reporter. Concomitant medications included birth control and AMBIEN.
This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (non-gsk); non-GSK manufacturer; unknown; unknown given on 2 April 2013; live attenuated human rotavirus vaccine; manufacturer unspecified; unknown given on 2 April 2013; PREVNAR (non-gsk); non-GSK manufacturer; unknown; unknown given on 2 April 2013. On 2 April 2013 the subject received 2nd dose of DTaP series as KINRIX (.5 ml, unknown, left thigh) and experienced inappropriate age at vaccine administration and vaccine administered at inappropriate site. On 2 April 2013, within hours after vaccination with KINRIX, the subject experienced fever. The healthcare professional reported that a 4-month old subject received KINRIX instead of PENTACEL (due to shortage) on 02 April 2013. The mother reported that the subject had a fever of 101 Fahrenheit rectally. At the time of the report no additional information was available. At the time of reporting the outcome of the fever was unspecified.
Hospitalization: ADMITTED 9/5/22 DISCHARGED 9/9/22.  Presentation to the ED: on chemotherapy presenting with general fever and weakness. Given the febrile neutropenia patient was started on antibiotics and admitted for antibiotic deescalation and trending of clinical course consultation with Oncology.  COVID-19 + date: 9/5/22. Treatment: BROAD SPECTRUM ANTIBIOTICS. Discharge to: HOME.
Patient called the pharmacy stating that his arm where he received the vaccine has been hurting for the past month. He stated that he takes pain med for other conditions (OXYCOTIN and NORCO) which is still not controlling all of the pain. He had heard (from internal) that others receiving shots from pharmacy hurt because given too high on the arm. I gave shot per protocol. He said he would visit dr this week.
PATIENT HAD INDICATED HE WAS 65 ON HIS IMMUNIZATION FORM, WAS ASKED IF HE WANTED THE SENIOR FLU SHOT FOR THOSE 65 AND OLDER AND HE SAID YES. IT WAS REALIZED AFTER ADMINISTERING THAT PATIENT DOES NOT ACTUALLY TURN 65 FOR 2 MORE MONTHS. MADE PATIENT AWARE ABOUT 30 MINUTES AFTER ADMINISTRATION. I HAVE FOLLOWED UP TODAY (72 HOURS AFTER ADMINISTRATION) AND PATIENT HAS HAD NO ADVERSE EFFECTS. INSTRUCTED TO FOLLOW UP WITH US OR PRIMARY CARE DOCTOR IF ANY BOTHERSOME SIDE EFFECTS OCCUR OR GO TO HOSPITAL IF ANY SEVERE EFFECTS.
Initial report received from a health care professional on 12 October 2009. The same health care professional reported another case which is described in case 2009-04285. A 44 year old female patient received an injection in the left deltoid of FLUZONE (lot number not reported). One day after vaccination, the patient developed nausea, diarrhea, abdominal pain and temperature of 101.2 degrees Fahrenheit. Illness at the time of vaccination was re ported as none. The patient's concomitant medications include XANAX for anxiety, CLARINEX and birth control. The patient's recovery status was reported as unknown. List of documents held by sender: none.
Mother called to report child had temperature of 1010 in the afternoon after the shot vaccinations. Stated a few hours, temperature gone after baby had warm bath. Then after 6 days, observed some rashes over baby's face, body, chest, and upper arms. Mother said moderate amount with redness and itchiness.
Patient had HPV and flu vaccine on her left deltoid area, then she had the meningococcal vaccine on the right deltoid area. Almost immediately after meningococcal vaccine was given child started to laugh uncontrollably and then to cry. She complained of shortness of breath and inability to move right arm. Vital signs were stable and normal. There was no change in color, no fainting episodes observed. She was conscious at all times and breathing spontaneously. No treatment was administered at this time, EMS was called immediately. EMS arrived 5-7 minutes later. Patient was transferred to hospital for further evaluation and management. Child left medical office walking without assistance to the ambulance.
Reports that within a couple hours after Influenza injection 01/13/11, developed severe burning in throat and stomach. Met daughter to go shopping. Couldn't stop coughing. Thought was going to pass out due the burning in stomach. Ate snack protein bar and didn't help. Ate lunch, but didn't help burning of stomach. Throat raspy, hoarseness, and felt some tightness. Mattering in both eyes, re, itchy. Coughing lasted a few hours. Went home took Tylenol, and went to bed at 18:00 and stayed in bed until the next morning. Felt some archness and stuffiness in sinus before going to bed. Woke up next morning and feeling well, symptoms were gone.
Chills, moderate fever, headache and body (joint) pain from 6am through 2pm.
Patient had mild diarrhea and temperature of 98.2 F, received vaccine, developed convulsion and temperature of 103 F.  Taken to ER.  Had negative CSF, urine, blood culture.  Continue to have temperature off and on, on 6-3-09 found to have right otitis media, given Augmentin and fever resolved.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. Information regarding concurrent or medical conditions were not reported. On 22-APR-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 40, lot number reported as L022261 with expiration date 01-APR-2016 (dose and route were not reported). No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
This spontaneous report as received from a physician, as part of a marketing research program refers to 11-17 year old female patient. The patient had no concurrent condition. On an unknown date the patient was vaccinated with her first dose of GARDASIL 9 (dose and route were not reported). There was no concomitant therapy. The reporter stated that patients faint in response to GARDASIL 9, boys faint more frequently than girls. On an unknown date 1 out of 60 girls fainted. After fainting the kids sit still until their "color comes back" and then they leave the Pediatrician office. The outcome of faint was reported as recovering. The event did not prevent administration of second and third dose of GARDASIL 9. The reporter considered faint to be related to GARDASIL 9. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Right hand swollen; Vaccine is making her sick; Right side of my face is swollen, cheek swollen; Lips swollen; Tongue swelling; Inside part of her cheek swollen; Throat swollen; Right Arm and hand swollen; Right wrist swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Right side of my face is swollen, cheek swollen), LIP SWELLING (Lips swollen), SWOLLEN TONGUE (Tongue swelling), MOUTH SWELLING (Inside part of her cheek swollen) and PHARYNGEAL SWELLING (Throat swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 0U1AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID (VITAMIN C CITRUS) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced SWELLING FACE (Right side of my face is swollen, cheek swollen), LIP SWELLING (Lips swollen), SWOLLEN TONGUE (Tongue swelling), MOUTH SWELLING (Inside part of her cheek swollen), PHARYNGEAL SWELLING (Throat swollen), PERIPHERAL SWELLING (Right Arm and hand swollen) and JOINT SWELLING (Right wrist swelling). On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right hand swollen) and VACCINATION COMPLICATION (Vaccine is making her sick). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 10-Feb-2021, SWELLING FACE (Right side of my face is swollen, cheek swollen), LIP SWELLING (Lips swollen), SWOLLEN TONGUE (Tongue swelling), MOUTH SWELLING (Inside part of her cheek swollen), PHARYNGEAL SWELLING (Throat swollen), PERIPHERAL SWELLING (Right Arm and hand swollen) and JOINT SWELLING (Right wrist swelling) had resolved. At the time of the report, PERIPHERAL SWELLING (Right hand swollen) and VACCINATION COMPLICATION (Vaccine is making her sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: update event stop dates and Concomitant medications and  treatment medications details.
4-14 days after vaccine injections pt experienced rash (day 12), fever, diarrhea. Rash spread over abdomen, lower extremities. At this time pt was exposed to another child with fever & did roll in cut grass and rash appeared after.
Dizziness; Brain fog; fast heart beat; shortness of breath; chronic migraine; stomach pain; diarrhea; chronic cough; high blood pressure; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FEELING ABNORMAL (Brain fog), HEART RATE INCREASED (fast heart beat), DYSPNOEA (shortness of breath) and MIGRAINE (chronic migraine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02821A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizziness), FEELING ABNORMAL (Brain fog), HEART RATE INCREASED (fast heart beat), DYSPNOEA (shortness of breath), MIGRAINE (chronic migraine), ABDOMINAL PAIN UPPER (stomach pain), DIARRHOEA (diarrhea), COUGH (chronic cough), HYPERTENSION (high blood pressure) and NAUSEA (nausea). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), FEELING ABNORMAL (Brain fog), HEART RATE INCREASED (fast heart beat), DYSPNOEA (shortness of breath), MIGRAINE (chronic migraine), ABDOMINAL PAIN UPPER (stomach pain), DIARRHOEA (diarrhea), COUGH (chronic cough), HYPERTENSION (high blood pressure) and NAUSEA (nausea) outcome was unknown.            No concomitants were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-183075 (Patient Link).
Heavy menstrual bleeding occurred about 12 hours after my vaccinne (at both first and second doses). My heavy bleeding consisted of emptying a 50 ml mentual cup every 1/2 hour to every hour for two-three days after onset. I became extremely amemic and could not get out of bed. Increasing my Aygestin dose to the maximum recommended dosage daily has stopped the excessive bleeding.
2 year old was given a full dose of FLUZONE (0.5mL) rather than (0.25mL).
Patient was very nervous walking into the vaccination room with her mom and expressed worry but willingly agreed to the vaccination in the left arm. Prior to vaccine administration, we verified if she had ever had to use an EpiPen after getting vaccinated and after the patient said no, the vaccine was administered. Immediately after the vaccine, the patient was still anxious and asked for water which was brought to her. Right after drinking some water, she verbally expressed that she wasn't feeling well and the pharmacist was called into the room and we called 911 at 11:57am. We brought over another chair for the patient to rest her legs and to be in a more comfortable position. The patient reported tingly fingers, seeing dots, hot and sweaty but not pale, had ringing in the ears, drifting, and her words were very slow. The paramedics arrived to the scene and tested her blood glucose levels and blood pressure which were normal. The paramedics made sure that the patient reported that she felt ok and left at around 12:20pm. Patient left comfortable to stand up and go home with her mother at approximately 12:30pm.
Nurse administered FluMist, then proceeded to give Hepatitis A vaccine IM.  After shot patient stated the room looks funny.  Then nurse noticed patient having a blank stare and not responding to her name (approx. 20-30 seconds).  Lips normal color.  Respirations normal.  Then she responded, but had the blank stare again, lasting approx. 10 seconds.  Patient was put on cot.  Patient crying.  Mother asking patient how she was feeling.  Patient not answering but continued to cry.  Asked her if she had difficulty breathing, continued to cry.  Pulse 78, respirations normal.  Did not seem to have difficulty breathing.  Patient continued to cry, but responded to how she felt.  She stated her body felt numb.  Asked her to squeeze nurse's hands.  Both hands equal and strong.  Able to move legs.  Still stated body felt numb.  911 was called as a precaution.  No changes when ambulance arrived.  Paramedics took O2 saturation, blood pressure, pulse.  All normal. Patient continues to cry.  Paramedics assisted patient to chair.  Patient continued to cry and refused to walk out of room to car.  Paramedics put patient on cot and transported to mothers car.  Mother was given instructions on what to do:  Monitor pt at home, go to ER if conditions worsen, call HD tomorrow with update, call physician tomorrow with incident.  Mother denied any medical Hx including seizure, medications, having a recent virus.  Stated patient had Tdap last week. Pt went home.  Did not go to hospital.  Paramedics and mother felt child was having a panic attack.  PHN attempted to call family a few times, left messages, but have no call back from parent.  PHN called patient's doctor and there has been no call from parent on this child recently.
left arm was burning, it was red; discomfort; vaccine leaked; underdose; It did not go into the deltoid muscle. It was given much lower.; fatigue; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort), PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23F) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE ((dose 1) (Lot# 025L20A) first primary monovalent dose) on 28-Jan-2021, MODERNA COVID-19 VACCINE ((dose 2) (Lot# 011A21A) 2nd primary monovalent dose) on 25-Feb-2021, MODERNA COVID-19 VACCINE ((dose 3) (Lot# 035C21A) booster dose) on 02-Sep-2021, spikevax ((dose 4)  (Lot# 005M21A) booster dose) on 15-Apr-2022, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 ((dose 5) (Lot# 055B22B) bivalent booster) on 14-Oct-2022 and SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 ((dose 6) (Lot# AS7180B)  bivalent booster) on 15-May-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 and spikevax.    On 18-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Sep-2023, the patient experienced BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort), PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (left arm was burning, it was red), DISCOMFORT (discomfort) and FATIGUE (fatigue) had not resolved and PRODUCT LEAKAGE (vaccine leaked), UNDERDOSE (underdose) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It did not go into the deltoid muscle. It was given much lower.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. It was reported that the patient received the 7th dose in the wrong site. It did not go into the deltoid muscle. It was given much lower. Some went under the skin and some to surrounding tissue. The patient also felt that the skin at injection site left arm was burning, it was red. Also felt discomfort and the patient believes that the vaccine leaked. The patient was feeling fatigue.  No treatment medication was reported.
Patient developed mild nausea. No additional symptoms. She was monitored x 25 minutes with no progression of symptoms, reported improvement. No treatments administered. Discharged home.
Maco-papular rash, few vesicles on neck and face, lasted 2-3 days. Atypical varicella.
Pt vaccinated with Engerix-B developed diarrhea, fever, nausea, sore throat, aches.
no additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.; This spontaneous report has been received from a healthcare business professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# W011278 experienced a temperature excursion above 46 Fahrenheit (F) (62.8F) for a timeframe of 8 hours 0 minutes and 0 seconds; no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number W011278, expiration date 01-NOV-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002779: US-009507513-2209USA002722:02242135 US-009507513-2209USA002532: US-009507513-2209USA002469: US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002510: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002746: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002574: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606:
All initial symptoms- soreness at site passed at day 3,   At day 5 woke up from sleep with headache, did not respond to excedrine, progressed to migraine with photo and sound sensitivity, called out of work for next shift (bedside rn) vomited twice, telehealth urgent care proscribed imitrex and zofran, encouraged ER visit if headache not relieved by first dose of triptan.   Migraine lasted about 9-10 hours from onset to pharmacy filling two new prescriptions for me to allowing medications time to work