chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started with me being extremely tired. I was extremely tired, and then on Thursday when I finally went to the Urgent Care I woke up with a bad migraine. I had a sinus infection, and I felt a lot of pressure in my face. I didn't feel congested, but I just felt the pressure. They gave me antibiotics for sinus infection. I had a lot of fluid built up. She could see it in my ears. The antibiotics have been helping me. They have me using a nasal spray too. I started them on Saturday and was able to go back to work on Tuesday. I am feeling quite a bit better, but it's not completely gone. It was really bad. I did not have any side effects immediately after this vaccine or the first one.
COVID-19 symptoms started 07/02/2022; tested positive 07/04/2022. I started with sore throat that seemed like it was going to get bad but it went away. On the 3rd the sore throat went away but my nose started running like a faucet and I kept blowing nose on the 3rd and 4th. I never had fever, a headache, or body aches. The runny nose was proficient for 48 hours and lasted another 3 days, but only mildly. I had the very slightest, occasional cough and once a day I took a cough drop. It was about 5 days of runny nose, but two days it was bad and then subsided. I used over the counter medication and used that for 2 days. My fever was 100.7 on the 5th during a telehealth appointment with my doctor and my pulse ox level was 97. I started PAXLOVID the night of the 5th and then I took that through Sunday morning the 10th. By about 3 PM I felt like I was running out of energy and up until 2 nights ago I was in bed by 8 PM and 2 nights ago I was up until 10 PM and back to normal. I would get fatigued.
While preparing to go to T ball practice, patients mother noticed patient had itchy bumps over her entire body. Diagnosis:  Urticaria Patient was given diphenhydramine 10ml by mouth in clinic.  Pt returned home.   Contacted patients mother approximately one hour after patient left clinic.  Patients mother stated patient is less itchy and outside playing.
pustules all over; chest pain; rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (pustules all over), CHEST PAIN (chest pain) and RASH (rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PUSTULE (pustules all over), CHEST PAIN (chest pain) and RASH (rash). At the time of the report, PUSTULE (pustules all over), CHEST PAIN (chest pain) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
20min p/vax pt devel hives on stomach, back, arms & legs;pt had no diff breathing;the hives resolved w/in 1hr;
was not able to get out to get the booster due to Covid; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 61-year-old patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received rapid 3-doses in August- September 2019). Concomitant products included INFLUENZA VACCINE (SEASONAL FLU SHOT).   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient received rapid 4-dose course of Twinrix for Hepatitis A and B in August - September 2019 and was due for 12 month booster dose in September 2020, but due to Covid and various precaution was not able to get out to get the 12 month booster dose. The patient also received seasonal flu shot a week before reporting. The patient asked the pharmacist that if it was too late (24 months, rather than 12 months) to get the 4th and final Twinrix dose, to finish the series, and he/she did not know was there any value in getting the final booster at this point or would he/she need to went through the whole series again, the next time he/she travel. The patient stated that he/she was not planning on any International travel anytime in the foreseeable future, but if he/she finish the series now, would it offer him/her any basic protection.
"very bad" headaches; one to two days of fever; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority Support received from a contactable nurse. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. The patient experienced "very bad" headaches and one to two days of fever on an unspecified date and the patient was in bed for 3 days. The outcome of the event headache was unknown and recovered for fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Neck problems/neck cracking/every time he moves his neck he feelsa pinch/sore movement; Never felt good since vaccination; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck problems/neck cracking/every time he moves his neck he feelsa pinch/sore movement) and IMMUNISATION REACTION (Never felt good since vaccination) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 06B21A and 012A21A) for COVID-19 vaccination.     Patient did not had any allergies. It was reported that patient has never been diagnosed/tested positive for COVID-19.  The patient's past medical history included Tooth lost (Teeth fell out).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck problems/neck cracking/every time he moves his neck he feels a pinch/sore movement) and IMMUNISATION REACTION (Never felt good since vaccination). The patient was treated with Manual therapy (Heating pads) for Musculoskeletal discomfort. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Neck problems/neck cracking/every time he moves his neck he feelsa pinch/sore movement) and IMMUNISATION REACTION (Never felt good since vaccination) had not resolved. Patient was not taking any concomitant medication.  Patient had received all the vaccines doses in deltoid muscle. It was reported that the patient never had any back problems. No other vaccine was received within 1 month prior to COVID-19 vaccine. Adverse event did not cause patient to cause seek medical care. Patient never experienced similar event in the past. Patient had received the treatment of complex sodium cream with no improvement and heating pads which stopped cracking.
This spontaneous report was received from a physician referring to a 18-month-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 12-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
PT VACCINATED WITH RECOMBIVAX HB APPROX 1 WK TO 10 DAYS LATER DEVELOPED ITCHING SEVER THEN FOLLOWED BY TOTAL BODY RASH.
Information has been received from a certified medical assistant concerning a 30 year old male who on 1/22/04 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot # 644568/1152M). Subsequently the patient developed a mild outbreak of varicella-type rash. The reporter stated that she could not remember the patient's identity or how many lesions he had. Unspecified medical attention was sought and no treatment was required. Subsequently the patient recovered. No product quality complaint was involved. Additional information has been requested.
VERY MILD SINUS HEADACHE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus headache regularly throughout the year. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043421A,expiry: UNKNOWN) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced very mild sinus headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very mild sinus headache. This report was non-serious.
About a week after the second dose, the right side of my jaw swelled up. It is very tender and painful, like a huge swollen gland on my jawline. Aspiririn and ibuprophin do not help vert much.
Patient fully vaccinated. Tested positive for Covid 19 on 12/30/2021. Patient was admitted to Hospital on 01/03/2022. Expired on 01/11/2022 while still hospitalized.
Diarrhea started 3/26/21 watery stools 4-5 times daily now 11 days post vaccine and not resolved as of yet. Palpable lump @ injection site as well. Pt Reports: Previsit planning completed on patient.  Recent labs, consult notes, imaging studies reviewed and obtained 24 hours prior to today's visit.  ; Barriers to care such as financial, poor family and social support, noncompliance, vulnerable patient due to age, and reccurent admisions were discussed with patient and none were present. Pt Denies: Self referral outside clinic; Recent Emergency Room or Urgent Care visits Pt Denies: Fever; Shortness of breath 79y/o F presents today due to Diarrhea. Pt had her 2nd Moderna COVID vaccine on 3/25. Later that night she felt fatigue with chills and sweats, but did not run a temperature. She felt "wiped out" for the next 3 days. The day following her vaccine on 3/26, she started with diarrhea. She's had diarrhea ever since then, now counting for 11 days. Pt describes the diarrhea as watery and it smells like burnt coffee. It's light colored and looks slimy. She denies black stools and blood in stools. She denies abdominal pain, When she eats she would go 4-5 times daily. She's avoided foods x 1 and a half days and it has slowed to 1-2 and less contents to come out. She is drinking plenty of fluids-water and sprite. She's take Imodium, now gone through 1 box, which is somewhat helpful. Pt reports her arm was very swollen and red after the vaccine. Right now she still has at the location. She's not taken her medications for about 4 days because wasn't feeling well and thought she shouldn't have all of that in her system. Of note, her Levo dose was increased from 25mg to 50 mg on 3/12, about 2 weeks prior to the onset of diarrhea. Vitals L/H 62.5 in; W: 223.0 lb; BMI 40.1; T 97.9 F Temporal; B/P 157/65 Sitting/Left Arm; P 85 BPM Brachial; R 13 BPM General: WDWN elderly obese WF, NAD Head: Normocephalic, atraumatic Skin: left deltoid with round palpable and mobile lump at injection site; feels identical to a lipoma Neck: no TMG. ***Written plan of care was given and pt informed that clinical summary will be available on the portal within 24 hours or available by mail if desired. Pt expresses good understanding of plan of care. Risks and benefits of treatment plan were reviewed with the patient. Advised to follow up for any new or concerning signs and symptoms.
Information has been received from a patient's mother via medical assistant who reported that her 20 year old daughter with no pertinent medical history or no drug allergies who on 06-AUG-2008 was vaccinated with the first dose of GARDASIL (lot # 660393/0067X). Concomitant therapy included hormonal contraceptives (unspecified) (oral contraceptives). About two weeks after vaccination on approximately 20-AUG-2008 the patient developed rash, hives over her face and sores in her mouth. The patient's rash and hives over her face and sores in her mouth persisted. Medical attention was sought via calling office. No product quality complaint was involved. Additional information has been requested.
BODY ACHES, CHILLS, FATIGUE, RHINORRHEA, NASAL CONGESTION, COUGH, SORE THROAT,
Patient states she woke up the morning of November 17, 2016 with matted eyes and swelling of the lips. She was encouraged to seek prompt evaluation by her primary care provider or Urgent Care/ER for reported symptoms and/or at any time if she feels symptoms are worsening.
On 11/8/00, had redness, swelling and soreness at site on right arm down to elbow. On 11/9/00 at 09:00, puffiness going down but little red and some swelling below elbow.
Parents presented child to ER with c/o rash. Recent hx of receiving varicella vaccine. Rash appeared 3-4 days after vaccine given.
Nausea and dizziness starting approximately 24 hours after vaccine administration. Progressed to flu-like symptoms (nausea, fever, chills, muscle aches, night sweats) approximately 30 hours after vaccine administration, which lasted approximately 24 hours.
Gave Moderna vaccine to 15 year old. Moderna is approved for 18 and older only.
By the evening. Child had redness, pain and swelling at injection site.  The next day pt had fever to 103.  Chills, sore neck & body aches.  By 818 fever, chills, resolved, no appetite & activities per Dr.  On 8/23 child c/o of neck pain rating 5/10 intensity.
pt CC of  light headed took pt's vitals to find pt HTN. BSL was 111. Pt refused transport to ED. Advised pt of rights and risks of refusal. Pt signed refusal. Advised pt to seek help if symptoms worsen EOR.
blood clots; headaches; diplopia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches". Therapeutic measures were taken as a result of thrombosis, headache, diplopia. Clinical course: During a routine phone call, the patient described various health issues following initial two-dose vaccine series and booster dose since 2021. Patient is an adult male approximately 40 years old. Patient describes symptoms of headaches, diplopia and blood clots that he recalls following vaccine doses and is actively being treated by his physician. Events took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201184242 same patient/product/event, different dose number;US-PFIZER INC-202201184241 same patient/product/event, different dose number;
This spontaneous case initially received on 19-Dec-2016, was reported by health professional and concerns a(n) 61-year-old male patient. Weight: not provided; Height: not provided Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLUIRA from 22-NOV-2016 to 22-NOV-2016 Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 22-Nov-2016, the patient received the vaccine the underwent temperature Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
This case was reported by a healthcare professional (medial assistant) and described the occurrence of high fever in a 4-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PEDVAXHIB (non-gsk); Merck; unknown; unknown given on 19 September 2013; PREVNAR 13 (non-gsk); Wyeth Labs; unknown; unknown given on 19 September 2013; ROTATEQ (non-gsk); Merck; unknown given on 19 September 2013. On 19 September 2013 at 16:00 the subject received a dose of KINRIX (.5 ml, unknown route, right thigh) as the 2nd dose in the DTaP series and experienced inappropriate age at vaccine administration and vaccine administered at inappropriate site. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP and the fourth dose in the IPV series. The preferred site of administration for KINRIX is the deltoid of the upper arm. On 19 September 2013, 10 hours after vaccination with KINRIX, the subject experienced high fever and diarrhea. On 20 September 2013, described as "the next day", the subject sought medical attention at the doctor's office. At the time of reporting the events were resolved. The medical assistant "assumes this was all resolved" since the subject "did not come back into the office." The healthcare professional considered the events were probably related to vaccination with KINRIX. Per the medical assistant, the physician's notes stated that "it was probably related to vaccination."
Girlfriend felt his lips were swelling and has had other allergic reactions to mushroom.  This observer did not observe swelling but family was concerned.  BP 120/78, HR 87, Pulseox 94%.  Benadryl 50 mg given.  Waited for observation an extra 15 minutes.  Patient felt good when he left.  Vitals stable.  Advised to seek med advise if symptoms persist or worsen.
This spontaneous report as received from nurse refers to unspecified patients of unknown age and gender. No information received regarding medical history and concurrent conditions. The nurse reported that since 01-JUL-2014, unspecified patients might have been administered with ROTATEQ (dose, frequency and lot# not reported) orally, that were not stored property. No adverse effects reported. This is one of the several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
pt recvd vax & exp nausea, dizziness, weakness, vomiting & diarrhea following vax w/Hep B;
3.5" diameter swelling; Hot to the touch; Redness; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and patient was healthy. The patient did not have any allergies to medications, food and other products. Concomitant medications included unspecified normally taken medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 12Apr2021 at 10:00, the patient experienced 3.5" diameter swelling with redness & hot to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received any treatment for the reported adverse events. The clinical outcome of the event 3.5" diameter swelling, redness and hot to the touch was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Client presented for 6mo. shots.  Parents had declined Rotavirus.  By mistake he received Rotavirus for the 1st. time @ this visit.  Talked to parents the next day re. the mistake of receiving the Rota. vaccine.  They said that the infant was feeling fine @ that time.  10 days later mother called to say that the infant came down with vomiting and diarrhea and that it affected both parents and older sibling.  She said their family physician told them it was from the one dose of Rotavirus.  There was no treatment except to keep family well hydrated; no one, including client, was hospitalized.
Myalgia Narrative: chills; bodyache ;feeling thirsty 1/22/2021
Patient received vaccine on 01/07/21. The evening of 01/13 experienced itching at the injection site. The morning of 01/14 noticed a welt, appeared to be a hive.  Saw her physician on 01/15. Per vaccine recipient, provider diagnosed local reaction and no infection. Able to proceed with second dose.
This spontaneous report as received from a certified medical assistant, via a company representative, refers to unspecified number of less than 10 patients. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with GARDASIL which was improperly stored (lot # J015378, expiration date 09-APR-2016)(doses, administrations sites and routes unspecified). This is one of several reports from then same reporter. Additional information has been requested.
Swelling under my right arm, which is the same arm that I got the vaccine in.  This was my booster shot.
Fever of 100.8 on 11/7/19 Mucus in eyes, nose, and throat. Rash from head to toe. Thrush diagnosis on 11/10/19.
Lots of physical pain and soreness, red and visibly swollen, hot to touch, pain in limbs and joints continuing for 2 days and counting.
Headache, Fever, Nausea Vomiting, fatigue Narrative: