chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after became nauseous for 4-5 days with occasional vomiting; then in addition developed fever along with prior symptoms for the next 5 days followed by continued nausea with occasional vomiting.; in addition developed fever; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included paracetamol (TYLENOL) used for unknown indication from unspecified dates, unknown if ongoing. The patient was not allergic to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 04:00, the patient became nauseous for 4-5 days with occasional vomiting, then in addition developed fever along with prior symptoms for the next 5 days followed by continued nausea with occasional vomiting. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of these events. On 07Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events nauseous, vomiting and fever was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE  10/01/2022 - RECURRENCE OF SAME SYMPTOMS
Fever beginning on date listed. 24 hours later a spotty rash appearing on face and trunk. Within 24 hours of rash first appearing on face and trunk, rash spread to arms and legs. Rash remained for another 24 hours before dissipating. During its course, patient continued to exhibit mild fever and the rash appeared to itch based on patient's behavior. Patient also showed lethargy and reduced appetite.
GERD acting up; Ice cold feeling her chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD acting up) and FEELING COLD (Ice cold feeling her chest) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included GERD on 15-Jan-2021 and Acute bronchitis on 15-Jan-2021.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD acting up) and FEELING COLD (Ice cold feeling her chest). On 15-Jan-2021, GASTROOESOPHAGEAL REFLUX DISEASE (GERD acting up) and FEELING COLD (Ice cold feeling her chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment included a heating pad.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Redness and swelling at the injection site on (L) Lateral thigh. Area was also itchy and hot to the touch. Practitioner prescribed AUGMENTIN to treat a cellulitis infection of (L) thigh.
This literature marketed report was obtained from published literature article as stated above and refers to a 26 years old female patient. The patient's medical history included double heart valve replacement. The patient was 0% HLA class I, only 12% sensitized to HLA-class II, and the virtual crossmatch against her donor was negative. As an inpatient for 3 weeks prior to transplant, the clinical team was able to report she had not incurred any sensitizing events. On an unspecified date, protocol fresh frozen plasma and hepatitis B vaccine (recombinant) (manufacturer unknown) were given to the patient. Flow crossmatch (FCXM) on the 1 month pre-transplant sample was negative, correlating with the original virtual. During the transplant, testing of the immediate pre-transplant sample revealed the patient was 100% sensitized to HLA-Class I and 24% to Class II, FCXM on the same sample showed strong T and B cell channel shifts, HIA-DSA titered as high as 1:512 and were strongly C1q-binding. This was a surprising increase from results collected one month prior to transplant. The clinical transplant team was alerted, and while the patient was fine at that time, within 5 hours of transplant, cardiogenic shock and rejection began. Early detection of sensitization allowed the transplant team to arrange for plasmapheresis (PP) antilymphocyte immunoglobulin (thymoglobulin) and eculizumab before the patient crashed. DSAs responded quickly to eculizumab, bortezomib and PP. Within 4 days post-transplant, DSA titers had fallen to 1:8, and a 1 week post-transplant right atrium biopsy was C4d negative. This was the most rapid response to therapy that had ever seen, and speculated that the hyperacute immune response and quick therapy, including PP and complement inhibitors, precluded a mature complement response and C4d deposition. As of 4 months post-transplant, DSA titers were maintained below 1:4 on tacrolimus, CELLCEPT and prednisone, and the patient entered cardio rehabilitation. While likely an anamnestic response pointing to a gap in HLA-specificity data collection, perhaps immunization could have served as a sensitizing event in this case. This case highlights the need for close monitoring for HLA-sensitizing and antibody specificity changes following hospitalization and vaccination. The outcome of cardiogenic shock and transplant rejection was recovering. The reporter considered cardiogenic shock and transplant rejection to be related to hepatitis B vaccine (Recombinant) (manufacturer unknown). The reporter considered the events, cardiogenic shock and transplant rejection as serious due to hospitalization. Upon internal review, cardiogenic shock was also determined to be other medically significant. Additional information has been requested.
I had the same reactions to both the first injection on 8/10/21 and 9/10/21. I had chest pain, high fever, sweats, chills, fatigue, joint pain, body aches, nausea, arm pain at injection site and could not get up from the floor for a day and a half following the injection. These symptoms lasted 2 days with only the headache lasting until the 3rd day.   What concerns me is that I am breastfeeding and my baby after nursing post my injection fell asleep within an hour and did not wake up until the next day. After the first injection on 7/10/21 , he fell asleep at 4pm and did not awake until 6am the next day. After my second injection on 8/10/2021 he fell asleep at 3pm and slept until 6am the next day. He did not awake for dinner on both occurrences. He has never done this before other than after nursing several hours after each of the moderna shots that I received. I pumped breast milk on 8/11/21 in the morning if you would like to study.
2 hours after flu vaccine injection, my arm was very painful, swollen and red. Blue and red pattern started to appear, then blisters appeared and kept on growing and filling up with liquid. It was extremely painful. Next day, the doctor burst the blisters to drain them. The skin ripped exposing flesh. Cortisone was prescribed with ibuprofen. Doctor said they would report to CDC but no one had followed with me.
Soreness in shoulder yesterday. The next day had headache and tiredness and fever with chills. Last night had sweats the whole night. Felt fine this morning, all symptoms had gone. Feels pretty good today.
The evening of the day of the second shot I got chills and a fever. I awoke the following morning with a bad headache, dizziness and nausea. At this point I took a tylenol and an antacid and went back to sleep. I did not get out of bed until 6:30pm. I still didn't feel great, but a lot better. I improved as the evening went on.
At first the injection site started to be extremely painful. Then chills, fever, weakness and general malaise. Diarrhea and cramping along with light headedness followed.
Following an MRI with Contrast, the injection site for my first COVID vaccine had an allergic reaction and itched and swelled and became very irritated and red (in about a 4 inch diameter oval on my arm).
I noticed a feeling of flushing, nasal and chest congestion and nose and mouth/lip tingling and swelling. Swelling of bottom lip worse on 10/07/2010 and nose numbness.
Started 24 hours after receiving vaccine.  Fever 3.4 degrees above normal, headache, vomiting, slept for 16 of 24 hours. Very sore arm, had 6" x 4" raised red area.
pt presented to ED with mild chest pain.  EKG normal. Mild troponin leak. Echocardiogram wnl. Discharged in ambulatory condition
Data exchange not properly working in E.A.R. office. Procedure did not include immunization reconcillation causing extra dose to be given.
Sore arm from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm from the first dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C47B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXCARBAZEPINE (OXTELLAR XR) for Seizure.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm from the first dose). At the time of the report, VACCINATION SITE PAIN (Sore arm from the first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications provided by the reporter.      This case was linked to MOD-2021-162348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 20-JUL-2021 contains no significant information
Area around shot is red; Area around shot is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Area around shot is red) and VACCINATION SITE SWELLING (Area around shot is swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around shot is red) and VACCINATION SITE SWELLING (Area around shot is swollen). At the time of the report, VACCINATION SITE ERYTHEMA (Area around shot is red) and VACCINATION SITE SWELLING (Area around shot is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details not reported by the reporter. Reporter details were not reported by the reporter.
Difficulty breathing, sore throat and difficulty swallowing, red eyes emitting a sticky substance.
Information has been received from a registered nurse concerning a patient who a couple years ago was vaccinated with the first and second doses of VARIVAX (Merck). It was reported that the patient who had received two doses of VARIVAX (Merck) tested negative for varicella antibody titers on an unspecified date. Additional information is not expected.
Right upper arm pain; Shoulder pain; her arm was stiil painfull with movement; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5MM97, expiry date 30th June 2020) for prophylaxis.   On 25th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pain in arm, shoulder pain and pain upon movement. The patient was treated with steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the shoulder pain and pain upon movement were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain and pain upon movement to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the Nurse Practitioner (NP) for an employee. The patient received Fluarix vaccine in her right arm and she reported that she was feeling right upper arm and shoulder pain and was still hurting on 18th October 2019. Hence the NP treated the patient with a six day steroid pack and she had no relief at all.  On 15th November 2019, the NP contacted the patient and her arm was still painful with movement that it would bring her to tears.  The NP consented to follow up. The patient can follow up with the reporter directly.  The patient had a scheduled appointment with their Primary Care Physician (PCP) this week. This case linked with US2019209636 and US2019209638, reported by same reporter.
This spontaneous report as received from a consumer, a patient's mother, refers to a 11 year old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. No information about concurrent conditions was reported. On 18-JAN-2017, the patient was vaccinated by a nurse with a dose of GARDASIL 9, injection, 0.5 ml (route of administration, lot number and expiration date were not reported). On 18-JAN-2017, (immediately after the patient received the vaccine), the patient experienced a seizure. The patient sought for medical attention (was visited by a physician) and was given orange juice as a treatment. No laboratory test diagnostic was performed. The outcome of seizure was reported as recovered/resolved on 18-JAN-2017. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of seizure was considered as medically significant. Additional information is not expected, as there was no consent to contact the physician.
pt reported 24 hours post booster spasms,limited range of motion.Pt took aleve and advil used voltaren no relief. Assured patient that the vaccination site was not near the shoulder when given but to seek physicians help.
After taking both series of vaccines of Moderna and Booster I developed Type 1 diabetes due to a decrease of vitamin D and C-Peptide, an increase of GAD-65A, and a positive Islet Cell Antibody Screen test.
Pt recv vax on 10/19/98; Pt may have recv vax IV instead of IM; no adverse rx
Patient reported and showed a rash that appeared a few hours after the vaccination. It is located on her chest, shoulders, neck, and lower scalp. She reports that her arm was very sore after the injection. She showed a red circular mark on her right arm which the injection was given. She stated it was hot to the touch as well as felt like there was a hard know under skin. She reported that this knot had become softer like it was going away. She stated that she went to the MD and was prescribed a Medrol dosepak b/c it looked like am allergic reaction. Patient still had a rash and the red circular mark on her arm on 2-20 but she reported that both were slowly getting better with time.
Information has been received from a health professional concerning a 13 year old female with no pre-existing allergies or medical condition or illness at time of vaccination who on 11-JUN-2012 was vaccinated with the first dose of GARDASIL (lot # 672834/0131AE) into her left arm. There was no concomitant medication. In the morning of 11-JUN-2012, the patient complained of dizziness. The patient moved to upon room, head and feet elevated. Ice pack was applied. The patient rested additional 20 minutes. The physician monitored the patient. The patient stated she was ok and left facility. The patient had no further complaint. No labs/diagnostics studies were performed. Subsequently, the patient recovered from the events. This is one of several reports received from the same source. Additional information has been requested.
Patient in 1st trimester of pregnancy,  5 minutes after vaccine  was administered patient fainted and fell off of chair.  Patient came to but 911 ER squad was called.  Squad said patients blood pressure dropped.  Blood pressure came back and patient felt better.   Squad monitored patient. Patient  felt better and went home.
This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of M-M-R II (strength, route of administration, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
chest discomfort; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (chest discomfort) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest discomfort). At the time of the report, CHEST DISCOMFORT (chest discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recv vax 16JUN95&25DEC95 pt devel chickenpox-like rash w/vesicles initiating in crops on the abd&progressing to chest,back,arms&legs,all of which crusted;also devel prodrome w/high fever
p/pt recv 2 vax exp generalized itching, felt hot all over, & devel lumps at site. within 2-3hrs pt devel swelling, pain at pnu-immune inject site. 3nov97, painful area of ecchymosis devel @ pnu-immune inject site.
Administering the Menveo to a 57 yo patient; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Administering the Menveo to a 57 yo patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter wanted to know the information on the safety on administering the Menveo vaccine to the 57 years old patient that will be travelling. The reporter stated that after reviewing GlaxoSmithKline and disease control information he decided that he will follow guidance and proceed to vaccinate the patient. No additional information provided. The reporter did not consent to follow up. The patient received Menveo who was older than the indicated age which led to inappropriate age at vaccine administration.
Swelling and redness (4 1/2 x 2 3/4) around injection site. Soreness for 48 hours.
Sulfur body smell to self & Others for a few days,smelled sulfur in urin next day; arm pain; sharp pain to little fingers on both hands for a few days; headache; itchy face & neck & torso for several days; This is a spontaneous report from a contactable consumer (patient). A 57 years old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Ew0150) via an unspecified route, administered in Left Arm on 31Mar2021 (at the age of 57-years-old) as Dose 1, Single for Covid-19 immunization. The patient's medical history included spinal stenosis, fibromyalgia and known allergy to molds. The patient's concomitant medications included fentanyl patch; hydrocodone bitartrate, paracetamol (NORCO) tablet and methocarbamol (ROBAXIN) within two weeks of vaccination. The patient previously received amoxicillin, Neurontin and experienced allergy to all. The patient was not diagnosed with COVID prior to the vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On an unspecified date in 2021, the patient experienced sulfur body smell to self and others for a few days, smelled sulfur in urine next day, arm pain for 3 weeks, sharp pain to little fingers on both hands for a few days, slight headaches for 3 weeks, itchy face and neck and torso for several days. Post vaccination, the patient was not tested to Covid. No treatment received for resulted events. The outcome of the events was not recovered. No follow-up attempts were required. No further information was expected.
Systemic: Anxiety -Severe, Additional Details: pt got anxious and was getting unconscious after 5 minutes of the shot. she was sitting on bench and her mother was right next to her and she was leaning on her mother who also received shot and mother mentioned that she had very bad reaction from blood drawn when she was 8 years old and every since she is not good with needles and shot per. She stated it's more anxiety compared to adverse reaction called 911 and paramedic came and evaluated she was breathing entire time, monitor.
I experienced Covid arm for 3 days starting day 9 after the first dose. After the second dose, I experienced significant swelling, heat, itching  and redness the size of a mango and raised 1/3 to 1/2 inch at the center. This developed on the day after the injection and did not fully subside for 10 days. Upon swelling going away, the skin over the entire area scaled, dried and flaked off like a burn.
This patient received a full, diluted multi-dose vial of the Pfizer COVID-19 vaccine instead of the single dose of .3mL. The patient was notified on Friday July 23, two days after receiving shot and reported a sore arm, but did not feel it was anything beyond what was expected.
Following the fourth dose of Infanrix, the pt was diagnosed with autism. As of 10/24/00, the outcome of the event is unknown. This is considered medically serious. On 03/19/01 the vaccinee's mother reported that her daughter received Tripedia (Aventis Pasteur) and nt Infanrix. As a result, this case has been logically deleted.
Watery diarrhea that lasted 6 to 8 weeks. C diff and stool culture negative. Had gastroenteritis the week before the vaccine but it didn't get better as usual. Husband had diarrhea too a week prior so pretty sure it was infectious. I also had a similar scenario after 2nd dose of COVID vax and had prolonged diarrhea at that time. I had diarrhea after 1st vax as well though didn't persist for this long. I have only had diarrhea at time of COVID vaccination over the past year; otherwise I have regular BMs.
4.19.2021   swollen purple ARM                  Redness  pain on  LeFT                  Arm x 3days  after                 vaccination  Day . 4.16.2021