chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one dose of ROTATEQ administered to patient outside of approved age indicated for use; No adverse effects; This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, frequency, lot number and expiration date were not reported) for prophylaxis. It was reported that the patient was outside of approved age indicated for use. No adverse effects were reported in association with this administration.
RASHES NOTED ON THE BOTH THIGHS THE DAY AFTER SECOND DOSE, PROGRESSIVE AND BECOMING GENERALIZED. SEEN ON 02/23/21 RX PREDNISONE.
7:00 a.m. Headache, low-grade fever, chills, body ache, nausea.
After my third vaccine, I had an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. I am now at the 72 hour mar; After my third vaccine, I had an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. I am now at the 72 hour mar; acute stomach pain; nausea; diarrhea; vomiting; very itchy palms and feet.; The itchiness/redness on palms, fingers, and feet are acute when my stomach does not hurt; This is a spontaneous report from a contactable Consumer, reported for herself. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3180), dose 3 via an unspecified route of administration, administered in Arm Left on Mar2021 as a single dose for covid-19 immunization. Medical history included colitis ulcerative, hypothyroidism, anxiety, drug hypersensitivity. Concomitant medications received within 2 weeks of vaccination Entivyo infusion, Ozempic (75). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3180), dose 2 via an unspecified route of administration, administered in Arm Left on Mar2021 15:00 as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm right on 30Mar2021 09:00 as a single dose for covid-19 immunization. The patient had allergies with sulpha drugs. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After my third vaccine, the patient experienced an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. "I am now at the 72 hour mark and I am not able to keep any food down. Additionally, last night I woke up with very itchy palms and feet. There was no rash nor itchy feeling at the injection site. The itchiness/redness on palms, fingers, and feet are acute when my stomach does not hurt." The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. Narrative was added with case closure comment. No F/up activities required as per the AEM01 FAQ, no F/U is required for off label use without an associated AE Follow-up attempts are completed. No further information is expected.
My oxygen has been in the 80's since receiving the vaccine. I have had more shortness of breath as well as coughing. I have been prescribed doxycycline 3 times and then LEVAQUIN. As long as I am on the antibiotics and steroids, I get better but once I discontinue use, the symptoms return. This last time it came back worse than before. I have been unable to see the doctor again as of yet, but I do intend to return once I am rescheduled.
Information has been received from a registered nurse concerning a 24 year old female with a sulfonamide allergy and no medical history, who on 08-APR-2008 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 08-APR-2008 the patient developed a hard lump with pain at the injection site. It was reported that the patient called the physician's office. No diagnostic laboratory studies were performed. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Intussusception 1/21/2015 w/ blood in stool, emesis. (S/P attempted air enema reduction x 6 that was finally reduced on the last attempt). (Done at medical center).
Pt vax /w HIB had T(R) spiked to 104.8 48 hrs /p inject, febrile seizure, Rt OM, flaccid, looking to lt, unresponsive /w labored breathing, gagging < 10 min, lethargy & confusion for few min /p inject.  May have had 2nd seizure 31DEC90.
titers have come back negative; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient's titers have come back negative and the doctor wanted her to restart the series. The reporter consented to follow up. The health care professional was unaware of timing of previous vaccination but she thinks it was a while ago. She was not sure if patient was even fully vaccinated or not.
Body aches; joint pain; nausea; severe chills; fever of 101.4 F; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; feels like she has the flu; This is a spontaneous report from a contactable nurse reporting for herself. A female patient (Age: 53; Units: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 04Jan2021 as a single dose for COVID-19 vaccination. Relevant medical history included she had COVID 19 virus on 13Nov2020. Concomitant medication was not reported. On an unspecified date in Jan2021, the patient reported that she was experiencing the same symptoms she felt when she had COVID 19 virus on 13Nov2020. She was currently experiencing the following symptoms: body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch. The patient reports that she feels like she has the flu. The outcome of the events body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch and feels like she has the flu was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Patient received Pfizer COVID vaccine on 3/6/21 and 4/1/21. On 1/2/22, patient had respiratory arrest at home and was intubated on the field. Patient was then admitted to our CCU with main diagnosis acute hypoxic respiratory failure, severe hypoxia (intubated with PE and positive COVID status), chronic diastolic heart failure with demand ischemia (s/p cardiac arrest precipitated by hypoxia). As of today (1/6/22), patient is still admitted in our CCU but already extubated.
sz occurred 36 hrs p/vax that day 102.5 ER had severe emesis day of sz;
Developed rash over torso and limbs, itchy but not raised  36-48 hours after receiving vaccine. Self treated with antihistamines - employee is a physician.
No adverse event; second dose of the primary series that was given too early; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the primary series that was given too early) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the primary series that was given too early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the primary series that was given too early) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the primary series that was given too early).    Concomitant medication was not reported. Moderna vaccine for children under 4 were given too early and they are looking for some guidance. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-663919 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663919:(child 1) (same reporter)
Couple of days after the vaccine I started bleeding heavy, and I had a massive blood clot which is what made me go to the hospital. I was monitored at the hospital me and the baby. Estimate date of delivery - Feb 19, 2021
Pfizer covid 19 vaccine lot # FJ6369 administered beyond use date on 03/25/2022, administered on 03/29/2022
pain in the legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the legs). At the time of the report, PAIN IN EXTREMITY (pain in the legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
22-year-old male who reports that on 9/10/21 he received the J&J COVID19 vaccine.  He was not taking any medication at that time, and had no previous symptoms or medical problems/conditions.  Patient states he had about 1 day history of fevers and chills that then resolved.  On 9/13 he began experiencing some shortness of air and presented to the medicine clinic.  CBC, EKG, chest x-ray were all normal.  Patient was satting above 94% on stationary and exertional SPO2.  Duo nebs nebulizer treatment was given.  The next day (9/14), patient reports one episode of diarrhea in the morning.  He then called clinic in the afternoon reporting approximately one hour history of substernal pressure-like chest pain about 3/10 in severity, which was associated with increased difficulty of breathing.  He was directed to go to the ED at that time.  During his stay.  Chest x-ray, EKG, and labs were unremarkable, however troponins were not drawn.  Patient was diagnosed with chest pain, unspecified type, and shortness of breath.  He was prescribed Atrovent and Toradol, and discharged.  Patient has not yet filled his medications.  Patient reports he again had one more episode of chest pain with shortness of air that evening before going to bed.  Patient additionally notes he went traveled on 3-7 September, but was not around any sick contacts that he was aware of.  Also went fishing recently and used some mosquito spray, of which some may have gotten into his mouth.  He notes allergy to pine nuts and shellfish, but no medications. Patient states he does not currently have chest pain, but still feels decreased ability to take in a deep breath.  No other symptoms or concerns at this time. Troponins taken in clinic for due diligence and are pending.
July 20-Aug 1 I had a cold. Symptoms included sore throat, dry cough, fatigue. My husband had those symptoms plus a fever and body aches. I called my primary care provider to get authorization for a COVID test, they authorized, and we received a COVID test on July 21st from Medical Center. Results came back on July 22nd that both my  husband and I were negative for COVID. We had been on a road trip on July 13-16 and were in close contact with various people. It seems we just picked up a cold, our first in 2 years. Symptoms gradually improved over the 2 weeks and today we are both feeling healthy again. [Note, below asks about a clinic visit - we had to call the clinic to get COVID test authorization, but did not visit, so I said none]
14 days after vaccination, I awoke with swelling and stiffness in right knee, as it got better it moved to left knee which was very swollen for 3 days, then both wrists became sore.  I still have carpal tunnel syndrome in right wrist.
burning underarm, very red in color, similar to diaper rash, spreading between breasts, itching, mouth burning then tooth fell out
VACCINE ADMINISTRATION ERROR DUE TO AGE. NO ADVERSE EVENT AT CLINIC OR IN FOLLOW UP
Headache, SkinRash, Sweating, thigh rash and headache Narrative:
FAULTY SYRING-Client did not receive the full dose of 0.5cc. Approximately half of the dose squirted out around the lower needle hub. These syringes are part of the supply that is sent in kits with the covid vaccines. Not sure how or why this happened.  Double checked syringe with volunteer who was helping administer vaccines. Volunteer technique appropriate.
pt recvd vax & 2 days later exp fever, myalgia, elevated liver function tests, h/a, anorexia;
Swelling and intense itching at the injection site.  Burning sensation under the skin. Timeframe about 14 hours in and still going.
3 minutes after receiving 3rd dose of Pfizer, client complained of feeling  ?dizzy and lightheaded?. Client also stated ?I feel like I?m going to pass out?. Clinicians attended to client and 911 called. Client cold and clammy.
2nd dose of Fluarix; given Fluarix, supposed to get Vaqta; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number HZ2JR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 21st October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were 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 as follows: The patient was inadvertently given a 2nd dose of Fluarix on the day of reporting, after receipt of her first dose on 8th October 2021, which led to extra dose administered. The patient was supposed to get Vaqta but received Fluarix, which led to wrong vaccine administered. The reporter consented to follow up via phone.
Pain at injection site, fever, chills, joint aches, overly sensitive to physical stimuli. Began about 6 hours after vaccine was administered and lasted about 24 hours. Standard OTC dose of ibuprofen every 6 hours provided slight relief.
The third day after the shot, she had a  head to toe rash; joint pain; extreme fatigue; low grade fever; back of her legs felt like fire like she had a hot poker in her leg; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (back of her legs felt like fire like she had a hot poker in her leg), RASH (The third day after the shot, she had a  head to toe rash), ARTHRALGIA (joint pain), FATIGUE (extreme fatigue) and PYREXIA (low grade fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (back of her legs felt like fire like she had a hot poker in her leg), ARTHRALGIA (joint pain), FATIGUE (extreme fatigue) and PYREXIA (low grade fever). On 28-Jan-2021, the patient experienced RASH (The third day after the shot, she had a  head to toe rash). At the time of the report, PAIN IN EXTREMITY (back of her legs felt like fire like she had a hot poker in her leg), RASH (The third day after the shot, she had a  head to toe rash), ARTHRALGIA (joint pain), FATIGUE (extreme fatigue) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. She had titanium in her back and legs.  Treatment information was not provided.
pt recv vax;began screaming & 2hr later pt still screaming;notified MD; advised to take pt in er; mom reports difficulty breathing; pt screamed 5 hr in total;
Given 2nd dose Pfizer FN2908 on 11/1/22. The lot number had expired on 10/31/22. Reports no adverse reactions
Soreness, redness, swelling, hot at injection site. Fever 100.0°, body aches especially in hands, headache, weakness, lack of appetite.
It started around 5am (almost 12 hrs after the injection), I got up for restroom, and I found out that I can't control my jaw from shaking, when I came back to the bed from restroom, I can't control my whole body from shaking (leg, and jaw mostly) and I can even easily hold a cup.  I thought I mught get too dehydrated - cause I feel thirsty in the meantime - which might destroy the balance of ion of Na+ in my body.  I drank nearly 1L of water and try to relax myself  Fortunately the symptom went away after 1 hr, and I started a low fever(which is totally fine to me)
jaw, gum and teeth pain from 6 pm - continues teeth discoloration noticed 48 hours later - top of teeth are white, bottom of teeth are gray - continues tooth chipping 2 weeks later
gotten the flu since getting the flu shot; gotten the flu; slight cold; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included influenza.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: gotten the flu since getting the flu shot) (serious criteria GSK medically significant), influenza (Verbatim: gotten the flu) and cold (Verbatim: slight cold). The outcome of the vaccination failure was unknown and the outcome of the influenza and cold were not reported.   It was unknown if the reporter considered the vaccination failure, influenza and cold to be related to Flu vaccine.     It was unknown if the company considered the vaccination failure, influenza and cold to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 The reporter reported the case via interactive digital media. The reporter said it was unusual that the patient got the flu, since getting the flu shot. The patient would never go without the flu shot. The patient had the full-blown flu before he/she started getting the flu shot, it was horrible, it was like a slight cold after getting the flu shot. The patient got his/ her first shingles shot day before reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Dizziness, face felt "weird", flushed, BP 198-101. Administered 50mg Benadryl no resolution. EMS contacted and transported to Hospital
Patient called on 10/12/13 reporting swelling/redness/warmth at site. After she came into our location she had a double area of redness - 2 inch dark red with given lighter red area that was better as of 10/14/13.
Left upper arm area of swelling and redness, tender. Approx 2"x3" two inches below injection site but not directly at injection site.
Started with muscle aches, then got a headache. Several hours later I had a low fever (99 degrees) and chills. I also experienced nausea. A few hours later my fever broke and the chills went away. The muscle aches are still there but are gradually subsiding.
Patient was AAOx3, ambulating independently prior to obtaining vaccine. Medical Assistant gave patient vaccine in Left Deltoid. Patient ambulated to observation area and sat in a chair. Five minutes into her observation, patient reported not feeling well. Medical Assistant notified Nurse Practitioner. Upon exam, patient was pallor, eyes intermittently rolling back, lethargic and unable to keep her head upright, nauseous and dry heaving, developed rigors, unable to verbally communicate but did nod her head yes to having difficulty breathing. No hives or rash noted. Epinephrine 0.3mg Pen (Lot # 0FM406, Exp Feb 2022) was administered in Right Deltoid. 911 was called by the Vaccine Clinic Supervisor. Vitals: Temp 97.7, HR 77, BP 134/76 (sitting), Pox 96% Room Air. After Epi administration, patient continued to be lethargic and the only thing she stated was "I do not feel well" but was able to communicate with head nods. EMS arrived and patient was taken to a Hospital.
This is a spontaneous report from a contactable Pharmacist received via a Pfizer sales representative. A 75-years-old female patient of an unspecified ethnicity received PREVNAR 13, intramuscular in the arm on 15May2017 at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 within couple of hours after vaccination the patient experienced a bout of vomiting with outcome of unknown.
Upon 10 or so minutes post-injection: Pain-muscular at injection site Pain down right side of arm Hot, swetting Nausea Numbness full body *Wet wash cloth received for forehead. Numbness hands, fingers, toes, tongue Cold and chills  *Received Benadryl  Ambulance to ED: Blood pressure spike  Shaking  Right jaw pain Now zero left pain   At ED: Vitals okay  *Received Pepcid and  Something under the tongue for nausea  Dry mouth Dry throat  Toes return to normal  Right jaw and neck and head pain *Practiced jaw exercises.  Still very cold. Less shaking, more intermittent like waves  Tongue and roof of mouth tingly Right quad pain  *Received Blanket and now warm  No headache pain.  Right injection site muscular pain.   Discharged from hospital