chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 2 month old child received their first dose of Prevnar in May, 2000. The grandmother described the child as being "very" sleepy. The child kept their eyes closed while drinking it's bottle. The child was taken to the physician's office where they were found to be arrousable and alert.
Extreme nausea, dry heaves, sweating, chills, unable to keep food (saltine crackers, Ensure) in stomach. NO FEVER, unable to lift head off pillow, unable to take Tylenol without  heaving.
I began feeling a bit "flu-ish" before going to sleep 11pm, so i took a baby aspirin. I woke middle of night (3am?), feeling dizzy, disoriented feverish. Trying to use the restroom, took me 2 tries, could barely walk, fell. I laid down on the carpet, fell asleep or passed out, woke after awhile (1 hour?), Sweating, clammy, obviously fever had broken. Felt weak, only mildly achy, next 8 hrs. Fine the next day.
Patient was in the hospital due to a pulmonary embolism. Patient does have a family history of blood clots.
injection site rash; Injection site itchy; injection site drynes; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site rash, injection site itching and injection site dryness. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the injection site itching and injection site dryness were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site itching and injection site dryness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The health care professional called to report that 2 months before the reporting date, the patient received Shingrix and around the injection site the patient experienced a rash. The rash has since resolved, but the area was still dry and itchy 2 months later.
Information received from a nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 01-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L023589, expiration date was 26-JUN-2017, strength, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Information has been received from a nurse concerning a 15 year old female, who, on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. The patient fainted after receiving the vaccination. The patient regained consciousness and was sent home. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
On the Thursday after my vaccine a reaction started on my face in my chin area-itching. Friday it started again but covering my whole face and then my entire body. I received a steroid shot and steroid pack from my doctor. I also had shortness of breath and a tight chest. Saturday I just had a little of the rash left. Sunday morning I woke up at 1 AM not being able to breathe like normal. My chest was tight and I could only take small breathes. I ended up in the ER receiving tests and blood work. To be told I had a reaction to the vaccine causing an entire body rash and not being able t breathe with my chest being tight.
This case was reported by a consumer (subject) and described the occurrence of back pain near shoulder in a 78-year-old male subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure. Concurrent medications included ZESTRIL and Aspirin. On 23 September 2013 at 13:30 the subject received a dose of Influenza vaccine unspecified (unknown details, right arm). On 24 September 2013, 1 day after vaccination with Influenza vaccine unspecified, the subject experienced back pain near shoulder (described as "back pain in right shoulder") and muscle pain. The subject sought medical attention with his physician about back pain in right shoulder after receiving vaccination, where he was told that it was most likely muscle pain. The subject "took ADVIL tablets for the pain but it did not go away." On 29 October 2013, 36 days after vaccination with influenza vaccine unspecified, the subject experienced pulmonary hypoinflation (described as "hypoinflated lung"). The subject sought medical attention on 29 October 2013 and was told he "had a hypoinflated lung." The physician prescribed him SINGULAIR which he started on 30 October 2013. At the time of reporting the events were unresolved.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter consumer or other non HCP for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Oct2021 (batch/lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (batch/lot number: unknown) as dose 1, single and administration date Feb2021 (batch/lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: COVID-19 test: (21Jan2022) positive for covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
stomach cramps; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Dec-2012. The patient experienced EXPIRED FLUMIST GIVEN which started on 27-Dec-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious. Expired vaccine was used.
Pt developed marked redness and swelling at injection site (about 10cm X 5 cm)
7.5cm x 5cm redness, warm to touch, induration to L deltoid.  No treatment given.
Information has been received from a healthcare professional concerning a 6-month-old female with an allergy to milk protein who on 16-JAN-2007 was vaccinated PO with the first dose of Rotateq (Lot #655175/0849F). There was no concomitant therapy. It was reported that on 07-FEB-2007, the patient developed diarrhea. No fever was noted. On 09-FEB-2007, the patient was seen in the physician's office. A stool test was negative for rotavirus and positive for Giardia. The patient was treated with Flagyl. On 13-FEB-2007, the patient recovered. Additional information has been requested. 06/01/2007 Information has been received from a physician and healthcare professional concerning a 6-month-old healthy female with an allergy to milk protein and no other medical history who on 16-JAN-2007 was vaccinated PO with the first dose of ROTATEQ (Lot #655175/0849F). There was no concomitant therapy or illness at the time of vaccination. On 07-FEB-2007, the patient developed diarrhea. No fever was noted. On 09-FEB-2007, the patient was seen in the physician's office. A stool test was negative for rotavirus and positive for Giardia. The patient was treated with FLAGYL. On 27-FEB-2007 (previously reported as 13-FEB-2007), the patient recovered. The physician did not feel the Giardia was related to ROTATEQ. Additional information is not expected.
Shortness of Breath causes by multiple large blood clots, put on blood thinners, seems to be fine, but has follow up appointment in March
Return of covid symptoms after Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Return of covid symptoms after Paxlovid treatment) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension, Immune disorder (NOS) (Weak immune response) and Allergy NOS. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) from 01-Jul-2021 to 26-May-2022 for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced COVID-19 (Return of covid symptoms after Paxlovid treatment). The patient was treated with AZITHROMYCIN for Adverse event, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Return of covid symptoms after Paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive Positive.         Company Comment: This spontaneous case concerns a 69-year-old male patient, with relevant medical history of asthma, hypertension, and immune system disorder, who experienced the unexpected non-serious AESI of COVID-19 that occurred 6 months and 19 days after the mRNA-1273 vaccine as 3rd dose. The event was supported with positive SARS-CoV-2 test. Patient took Azithromycin and completed Paxlovid as treatment regimen. Patient reported that COVID symptoms returned after Paxlovid treatment. Clinical course was not reported. The outcome of event was reported as not resolved. There was no information provided regarding the first 2 doses of vaccination. Patient's co-morbidities could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with relevant medical history of asthma, hypertension, and immune system disorder, who experienced the unexpected non-serious AESI of COVID-19 that occurred 6 months and 19 days after the mRNA-1273 vaccine as 3rd dose. The event was supported with positive SARS-CoV-2 test. Patient took Azithromycin and completed Paxlovid as treatment regimen. Patient reported that COVID symptoms returned after Paxlovid treatment. Clinical course was not reported. The outcome of event was reported as not resolved. There was no information provided regarding the first 2 doses of vaccination. Patient's co-morbidities could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.
Delayed Hypersensitivity rash. Generalized urticaria 2 days post shots. Possibly from shots.
Increase in touch sensitivity, spinning, swinging of head back and forth while seated at the table for meals, inability to stay seated at the table for meals more than 5 minutes, challenges in emotional regulation, significant squirming while seated, overwhelm in social situations and social anxiety, listening to only one song on repeat, blank staring, use of visual schedule to support daily routines, difficulty with transitions, explosive and aggressive meltdowns, difficulties with word retrieval, increased humming, restless sleep, night terrors, difficulties with motor planning
Right arm was slightly sore for the first 3 days then dissipated. Then on 4/ 14 around 11 pm I was getting ready to go to bed and my arm began hurting and I noticed it was a bright red area around the injection area. It was began to get progressively itchy and warm. At this point It is very itchy, inflamed, and hot to touch.  Currently using antihistamine alternating between Benadryl,  and xyzal Orally. Also using cortisone 10 cream, Benadryl anti itch cooling spray, and ice packs topically. Also taking Tylenol for pain which is about a 5/10.  I just recently associated these symptoms with the vaccine due to evidence based articles I?ve been following guidelines found there however I plan to contact my pcp on Monday as it is Saturday and the office is closed.
Arm pain began by 6pm on March 19, about two hours after receiving the vaccine. I woke up the next morning (March 20) feeling very run-down, moderate-to-severe fatigue, dizziness bordering on vertigo (historically this is part of severe fatigue for me), and my core temperature dropped from my normal of 96.8 to 95.5 (my core temp historically drops instead of rising for mild illness--I'm either chilled and mildly ill or have a fever of around 103 and am severely ill) and rose no higher until symptoms abated on the 22nd.
VACCINE GIVEN. 2 WEEKS LATER I WAS EXPERIENCING EXTREME FATIGUE. I AM A PHARMACIST AND PERFORMED AN ANTIBODY TEST AT WORK. IT WAS POSITVE FOR IgM antibodies to Covid19. NO IgG present. ANTIBODY TEST PERFORMED ON 01/12/2021 WAS NEGATIVE FOR IgM AND IgG AT THAT TIME. FATIGUE CONTINUED. HEART PALPITATIONS BEGAN SHORTLY THEREAFTER. I FINALLY WENT TO GET THESE PALPITATIONS EXAMINED AT MY DOCTOR'S OFFICE ON 06/16/2021. 12 LEAD ECG SHOWED SINUS BRADYCARDIA AND BIFASCICULAR BLOCK.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patients wife called and said her husbands arm was swollen from shoulder to elbow and feeling hot.  told them to go see doctor asap
muscle fatigue in the injection arm; This case was reported by a nurse via call center representative and described the occurrence of muscle fatigue in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced muscle fatigue. On an unknown date, the outcome of the muscle fatigue was recovered/resolved.   It was unknown if the reporter considered the muscle fatigue to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself The injection felt more viscous to the patient. The patient suffered a little muscle fatigue in the injection arm but no systemic reactions. The reporter consented to follow up. For drug tolerance, refer case US2020107074.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107074:same patient
Pt began to develop pain and "tightness" in left shoulder & neck 2 days following vaccination and had ecchymosis at vaccination site.  Pain progressively worsened over following weeks finally prompting return OV this past week X 2.  Pt now complains of severe pain in left upper extremity/neck/shoulder which is resistant to OTC pain remedies, Flexeril, and Tylenol #3.  Pt returned 7/19/03 after OV on 7/17/03 with interim phone call to on call physician.  Pt now complains of intermittent forearm numbness on the left and weakness in left upper extremity.  Pain is debilitating patient, and she is unable to sleep.  Pt was started on Prednisone and narcotic pain meds on 7/19/03.
Huge swelling in arm and shortness of breath x 3 days, and had fever.
Vaccine booster date:  12/9/2021:  Following fever (99.1 to 101.9), headache, body aches, experienced red, welt/hives/ rashes, throughout body with itchiness approximately 24 hours after injection.  Experienced some nausea and breath shortness.  Sought medical attention and received IV steroid, IV Benadryl, and IV NaCl fluid as treatment.  Ongoing at home treatment:  OTC Benadryl every 6 hours, Prednisone pack.  The skin issues - redness, itchiness, hives, etc. appear, disappear, and reappear throughout body- faces, neck, arms, hand, back feet , buttocks and continues as of this submission.  To follow-up with primary care physician.
This report was received from a Nurse Practitioner referring to an 18 year old patient of unspecified gender. Medical history and concomitant medications were not provided. On 25-OCT-2017, the patient was vaccinated with their first GARDASIL 9 (lot # N017697; expiration 21-JAN-2020) by a physician. It was given with BEXSERO. Immediately after the injection, the patient developed feeling dizzy. The physician reported he believed it may be an anxiety response. The patient returned to the office the next day and all symptoms resolved. The reporter did not provide causality assessment. This is one of several reports from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1710USA007830: US-009507513-1710USA007799.
Vaccine was at room temperature for>6 hours at time of administration. Weak, chills, very sore arm, and diarrhea.
Adverse Event Safety Officer reports guest who received Pfizer vaccine (Lot #EW0164) had a syncope episode within seconds of being vaccinated.  Intervention\Treatment\Why it Happened Guest was assisted to the supine position and LE elevated. Aid (EMT?s) were called and responded and assessed for further interventions. (B\P: 110\49, P-84, SPO2 ? 98% r/a). Guest reported to EMT?s that he has a history of feeling faint with vaccinations.  Outcomes Guest was assessed by EMT?s and no further interventions indicated and released to the Vaccination Post Op Area. Monitored for 30 minutes with partner and reported no further concerns or issues.
1 1/2 hours after receiving vaccine had nausea,  headache, vomiting  and shaking . Symptoms lasted about 1/2 hour
Information has been received from an allergist via a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with GARDASIL. Subsequently after the vaccination, the patient experienced itching all over the body and "other allergic reactions". No other information regarding the patient and events were known at the time. Additional information has been requested.
Approx 1 hour after vaccination, patient reported pain on left side of neck, next to trachea. Later in evening, she developed an itchy rash under both armpits. Still symptomatic today. Advised hydrocortisone cream &/or P.O. antihistamines for itching. Advised follow-up with physician if symptoms worsen. Still has symptoms at this time.
The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date vaccine removed from freezer to refrigerator 27-Apr-2022 1020. Date vaccine administered to patient 28-May-2022 0830. No treatment information was reported. No adverse events have been reported by the 7 patients at the time of the call.
This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 24-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M017334, 05-OCT-2017. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient experienced immediate burning sensation upon insertion of needle and injection of vaccine. Since injection has been experiencing sever upper arm/shoulder pain and limited ROM.
the day after vaccine, I had a red welt on the arm. it went away after 2 days and then again at day 9 it reappeared and is very itchy. Still there.
mom called p/hr spoke w/MD & stated pt was crying very bad since vax;MD thought this could be rxn to pertussis;
Patient has received an extra dose of COVID-19 Vaccine. Patient has completed vaccine series previous to this dose.  First dose: Moderna 02/03/21, Second dose: Moderna 03/03/21, Booster dose: Moderna 12/03/21. Extra dose administered Pfizer 03/22/22.
Patient was 17 yo at time of vaccine given.  no adverse reaction noted, patient may have left prior to recommended 30 min wait time.