chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1: Injection given in office at routine visit. Day 2: 12:30pm extreme lethargy (as referred to moving forward: limp, heavy eyes, little movement, however, can still move limbs and neck) and low grade fever of 100.3; extended nap, normal eating and drinking habits, extreme lethargy; 6:00pm fever of 102.3 - treated with Infant MOTRIN; normal night sleeping habits. Day 3: No fever upon waking up, however, still lethargic; 10:30am fever of 101; extended nap and increased discomfort/fussing; 2:00pm fever of 102.5, treated with Infant MOTRIN; called nurse at Pediatrician and discussed being seen next day if no improvement; very restless night. Day 4: Woke up with fever of 103 - treated with Infant MOTRIN and given bath; called Pedatrician and made appointment for 9:45am; seen by Pediatrician with outcome: all physical exams ok, told to treat with MOTRIN and/or TYLENOL as needed and make comfortable; continued extreme lethargy and fever throughout the day, treated with MOTRIN and TYLENOL. Very restless night - fever spiked to 105. Called night nurse through Pediatrician and walked through treatment, symptoms.  Made appointment for Saturday morning. Day 5: Woke up with continued fever - low grade at this point. Seen by NP at Pediatrician. Blood count via finger prick taken. White blood cell count normal, however, lymphocytes elevated. Told to make comfortable, continue treating with MOTRIN/TYLENOL, and sleep. Advised of wet diaper expectations, continue to push fluids, and return to doctor if no improvements by Tuesday or Wednesday. Extreme discomfort and hard stomach (almost as if bloated) later in day while inconsolable crying, called on call nurse back, advised to seek emergency medical treatment if more than one hour of inconsolable crying. Day 6: Fever free, extreme discomfort and bloating, suspended use of MOTRIN/TYLENOL due to potential constipation, rash presented beginning at hairline and eventually all over trunk. Day 7: Fever free, rash still present, woke up with mild congestion.
Fever up to 102.9°F, aches, pains, chills, fatigue.  Took Tylenol on the advice of the triage nurse at the VA. Fever reduced.
Tired, Facial swelling (Took zyrec), looks like chipmunk, swelling of left eye brow,
My outer arm turned all red I went to the doctor the next day and saw a nurse practitioner. I had lymph node under my left arm rashes under my left arm I had the rashes for 6 to 7months I was putting hydrocortisone on the rashes twice a day.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On 25-OCT-2017 the patient was inadvertently administered an expired dose of M-M-R II rHA (recombinant human albumin) (lot # L005290, Expiry date: 17-FEB-2017) for prophylaxis. Concomitant therapies included sterile diluent (Lot # N023306, Expiry date: 20-JAN-2020). The diluent used to reconstitute this dose was not expired. No adverse effect reported. There was no product quality complaint involved.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Sep2021 (Lot number: EW0172, Expiration Date: 30Nov2021) at the age of 63 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "MS", start date: 1992 (ongoing); "Thyroid disorder", start date: 1975 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (medically significant) with onset Sep2021, outcome "recovered" (Sep2021), described as "Feeling like I was paralyzed"; MULTIPLE SCLEROSIS (medically significant) with onset Sep2021, outcome "unknown", described as "Aggravated my MS"; PAIN (medically significant), outcome "unknown", described as "Very painful throughout my body". The patient underwent the following laboratory tests and procedures: blood thyroid stimulating hormone (0.350-4.940): (22Dec2021) 1.300, notes: Normal; magnetic resonance imaging: (20Dec2021) unknown results; (22Dec2021) unknown results. Therapeutic measures were not taken as a result of paralysis, multiple sclerosis.
This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received SHINGRIX for prophylaxis. In March 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, upset stomach and diarrhea. On an unknown date, the outcome of the fever, upset stomach and diarrhea were unknown. It was unknown if the reporter considered the fever, upset stomach and diarrhea to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient received single shot a week before reporting day and at the time of reporting had a fever, upset stomach and diarrhea. The patient refused to provide demographic information or physician information. Lab Comments: On an unknown date lab test was performed.
patient got his vaccine, put his shirt back on and buttoned it up and asked if it should be sore already.  I told him, yes the shot may cause some discomfort after injection and he was standing at this point.  He was about to say something and he fell backwards and hit a mobile laptop cart and the wall.  The patient went unconscious not talking but breathing was given an epipen and 911 called vaccine given a few minutes before 12:30 and 911 called at 12:29.  He regained consciousness fairly quickly and was assessed by the pharmacist and then EMT and transported to the hospital for monitoring.
24 hr. after vaccination, patient stated she had a swollen knot the size of a small orange on her left deltoid region in addition to swollen lymph nodes in left armpit area. Patient alternated warm & cool compresses with MOTRIN by mouth. Today 12/7/10 the know is the size of a quarter.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old male patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles and rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: Some time after receiving the 1st dose of SHINGRIX on left deltoid, the patient developed shingles and rash. The patient was prescribed Valtrex and the shingles resolved. For tolerance to 2nd dose refer linked case US2018GSK188479.
p/few min of vax pt lost conscious fell recovering & referred to ER;rxn to vaccine;
pt recvd 1st dose of Hep B vax on 7JAN92; next day devel thirty pruritic papular lesions that resembled insect bites on back & lt forearm around the inject site;
Pt recv vax on 3/8/99; on 3/9/99 pt exp left thigh swollen & red; dx=cellulitis
This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a adult female patient who received ENGERIX B adult (batch number 3744L, expiry date 17th May 2016. Concomitant products included ENGERIX B adult. On an unknown date, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the drug dose administration interval too short to be related to ENGERIX B adult. Additional information received: A patient inadvertently given her second dose of ENGERIX B 3 weeks after the 1st dose.
Information has been received for interferon beta 1a (Rebif). This was originally reported by a physician concerning a 60 yr old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot not reported). Concomitant medications included interferon beta 1a (Rebif). Subsequently the pt experienced flu like symptoms consisting of an increased temp (fever of 104.4F), chills, nausea and fatigue. The physician reported that she was not sure if the symptoms were due to the vaccine, the interferon beta 1a (Rebif), or a combination of the two. The pt's outcome was not reported. No further information is expected.
LIKELY LICHEN PLANUS. i STILL HAVE A HINT OF IT, ALTHOUGH MUCH HAS FADED. I AM REPORTING, BECAUSE IT DID SEEM NEAR TO THE TIME i HAD THE VACCINE. i ALSO UNDERSTAND THAT LICHEN PLANUS CAN BE AN ABNORMAL IMMUNE  REACTION. BUT I HAVE NOT SEEN IT LISTED AS A POSSIBLE REACTION TO THE mRNA VACCINES.
Fairly significant injection site pain; This is a spontaneous report from a contactable patient. A 33-year-old male patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot/batch number: EM9809), via an unspecified route of administration on the left arm on 16Mar2021 at 13:30PM (age at vaccination was 33-year-old) for COVID-19 immunisation. His medical history and concomitant medication were not reported. Prior to vaccination, he was not diagnosed with COVID-19. Since the vaccination, he had not tested for COVID-19. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unreported date, she experienced injection site pain after 12 plus hours of vaccination. The patient did not receive any treatment for this event. At the time of report, the clinical outcome of the event injection site pain was recovering. No follow-up attempts are needed. No further information is expected.
After 24 hours of vaccination a lot of pain in the arm, fever and muscle pain in all body.  After 48 hours of vaccination in addition of pain in the arm, I have a lot of itching and warm the area of vaccination in the arm.
Mother states Pt. had one day following immunizations a warm, redden area approx. 1" in diameter on L leg.  Mother had a doctor appt. and had child looked at then (2nd day after immunizations).  Instructions given to ice area and give OTC analgesics.  Later that day after child was riding his bike outside he had a rash which cleared after a cool bath.  Mother then took child to emergency room.  ER instructed her to ice leg and use OTC Advil.  Mother denies any fever.  States child is fine now, 7/24/06.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot number were not reported). After being vaccinated, the patient developed injection site swelling and redness. The patient visited the physician, who concluded that the patient had Staphylococcus infection that was caused by PNEUMOVAX23. It was also reported that the patient had received PNEUMOVAX23 less than one year before receiving another one. The patient sought medical attention. The outcome of the events and action taken was not reported. The reporting pharmacist considered Staphylococcus infection to be related to PNEUMOVAX23. The relatedness for injection site swelling and redness was not provided. Additional information has been requested.
No symptoms or signs for patient. Medical office assistant accidently administered Hep A and Hep B vaccines from wrong stock instead of private adult. Two pediatric Hepatitis A vaccines were used to equal 1 adult dose (1440 EL.U) and same for pediatric Hepatitis B vaccine (20 mcg).  I was advise by my responsible entity to report incident. Medical office assistant who administered vaccines made an incident report with workplace as per policy and was re-education on vaccines.
Administerd to 118 patients; There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administerd to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administerd to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administerd to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: patient demographics were updated.
The shot was administered too high in my arm. It was painful and I felt resistance as the needle was going in. The pharmacy was very busy that night and I had to wait well past my appointment time. The pharmacist had a lot on their plate with complaining customers, ringing phones and administering vaccines and was distracted. I always have soreness in my arm afterwards, but this pain continued. I had an initial teladoc visit where they told me I had SIRVA due to improper vaccine placement in my arm and it likely was given to me in my bursa sac instead of my muscle. I'm still dealing with the pain 3 months after vaccine.
Viral ear infection; Nystagmus; Could not stand; trouble with balance; Vomiting; Vertigo; was a test pilot and is unable to do that now; This case was reported by a nurse via call center representative and described the occurrence of ear infection viral in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (on an unknwon date received older shingles vaccine). Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On 1st October 2019, between 1 and 2 weeks after receiving Shingrix, the patient experienced ear infection viral (serious criteria hospitalization), nystagmus (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), vomiting (serious criteria hospitalization), vertigo (serious criteria hospitalization) and impaired work ability. On an unknown date, the outcome of the ear infection viral, nystagmus, difficulty in standing, balance difficulty and impaired work ability were unknown and the outcome of the vomiting and vertigo were recovered/resolved.   The reporter considered the ear infection viral, nystagmus, difficulty in standing, balance difficulty, vomiting, vertigo and impaired work ability to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced vertigo, could not stand, vomiting around 1:00 PM and had to be dragged to an ambulance and taken to the hospital. The patient was in the hospital for two days. The final diagnosis was a viral infection in his left ear. As per reporter, the patient was a test pilot and was unable to do that now. The patient He had two hours of testing and the audiologist thinks it is related to the vaccine. The patient was no longer vomiting, this stopped in the emergency room, but he still had trouble with his balance, nystagmus when it is dark out. The reporter consented to follow up.
Shortness of Breath, hard to breathe, vomiting, diarrhea, body aches, and low oxygen count, radial pulse, high blood pressure, white blood count was high.
Profound hearing loss in right ear; Tinnitus in left ear.  These symptoms began the evening after the dose was administered and were intermittent throughout each day, eventually resolving entirely about a week later.
My child never been immunized before, the school had certificate of exemption on records. She begin to lose hair on her head partially with big chunks, and now its getting worse.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 07-SEP-2016, during the administration of single-dose vial of GARDASIL 9 lot # M018810 (expiration date 28-MAY-2018), intramuscularly to the patient, some of the vaccine leaked out of the needle and onto the patient's arm. Nurse put a new needle on the syringe and attempted to administer the rest of the dose in a separate injection, but she could not advance the plunger. This resulted in administration of a partial dose of GARDASIL 9, which nurse reported she felt was "about 0.4 ml". No adverse effect was reported. The outcome of the adverse events was not reported. Additional information has been requested.
About 14 hours after vaccine around 10:00PM, I had body aches, chills, fever, soreness at injection site. This morning, I noticed shortness of breath when I was moving. I still have soreness at injection site and shortness of breath. Took Tylenol 500 mg this morning. Body aches are a little less. I still feel slightly feverish.
Patient was administered a seasonal flu vaccine, after the vaccine was administered, it was discovered that the patient had already received on this flu season.  The patient was also vaccinated with COVID Moderna Primary Series for 6-11years instead of 12 and older that he should have received. Patient's mother was notified of the error.  Patient is scheduled to be re-vaccinated with Moderna  Primary Series 12 and older 8 weeks from 11/10/2022 so that patient will complete his primary series.
Within 26 hours of getting 2nd MENACTRA (6/6/13 pt. developed severe (R) parietal headache 8/10 and severe fatigue, headache better when reclining; no N/V.
Unsure if related to actual vaccine, but patient experience shortness of breath shortly after receiving the vaccine.  On-site provider was notified.. patient was assessed and epi-pen was administered by NP
Vaccination given:  04/14/2003  04/25/03 - patient felt body aches, headache, sore throat, nasal congestion, joint pain, fatique and slight rash.  05/01/03 - came to Employee Health to report symptoms.  Rash is red spots - not raised - no itching - on arms and legs - spots separated - no drainage. No fever - temp. 97.1- oral.  Knuckles on bilateral hands are quite noticably swollen and red.  Patient states; "It's hard to move them because they are so stiff."  Sore throat when swallowing - neck glands are tender to the touch.  Patient made appt. with PCP for today.
Reports 2 days after receiving vaccines developed hive like areas on her leg. Reports had two areas at a time. Reports every day since that time she has had two areas in different places, her abdomen, back, shoulder around her collar bone. Reports areas itch, no fluid filled or weeping areas. Reports areas go away and leave a red area. Denies any other symptoms.
Side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose; unknown if might have experienced; Side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose; unknown if might have experienced; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (First Booster; unknown manufacturer), for Covid-19 immunization. The following information was reported: RHINORRHOEA (non-serious), DIARRHOEA (non-serious), outcome "unknown" and all described as "Side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose; unknown if might have experienced".  Additional Information:Concern, caller stated, "I want to know, is there side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose (unknown if might have experienced)?"  When paraphrased the concern, caller stated, "Right."As caller abruptly hung up the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Face numbness, racing heart, high blood pressure starting 20 minutes after injection. Took extra blood pressure medication. Symptoms started to subside. Some numbness in lips are still numb four months later.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Chronic diarrhoea, Weight loss, Nausea, Abdominal pain generalized, Pain in thoracic spine, Viral syndrome, Contusion of chest wall, Closed fracture of four ribs, Chest discomfort, Esophageal spasm (Nutcracker Esophagus), Dysphagia, Ankle sprain (Let ankle sprain), Headache, Appetite lost and Fatigue. Concurrent medical conditions included Mood disorder, Memory loss, Primary sclerosing cholangitis, Anxiety, Chest wall pain (Chronic from closed rib fractures), Chest wall discomfort (left posterolateral) and Acid reflux (esophageal). Concomitant products included CELECOXIB (CELEBREX) for Pain, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: results not provided Physical exam, routine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other investigations include Lab exam, pre operative examination, Observation and evaluation for suspected exposure to other biological agent, Screening for prostate cancer, skin cancer, lung cancer, colon cancer, physical examination.  Concomitant medications include long term use of non steroidal anti inflammatory drugs.
Mom called and reported child had "welts" elongated on buttocks and abdomen when she woke up the day after receiving vaccines. Slightly red and warm to touch. Told her to see PMD. Saw doctor that day and was given BENADRYL and CLARITIN. Mom reported the welts spread to legs and shoulders the evening of 8-6-08 and resolved 8-7-08. Mom did not check child's temp.