chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body pain; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body pain), HEADACHE (headache) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MYALGIA (body pain), HEADACHE (headache) and PYREXIA (Fever). On 22-Mar-2021, MYALGIA (body pain) and PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medications were reported.
7/27/09 Pt. called to c/o continued swelling of (L) deltoid area - onset day after ADACEL injection at same site. Also had malaise and fever which subsided. Status deltoid area feels warm and looks blotchy" - no raised rash. Had significant pain last week - subsiding. Follow-up - resolved without treatment by 7/30/09.
+ PCR test/fatigue/HA/nasal congestion/cough/body ache/fever; + PCR test/fatigue/HA/nasal congestion/cough/body ache/fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "+ PCR test/fatigue/HA/nasal congestion/cough/body ache/fever". The event "+ pcr test/fatigue/ha/nasal congestion/cough/body ache/fever" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: covid test type post vaccination=Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical information included as Location of injection for vaccine received within 4 weeks Prior: seqirus- Right deltoid. Did the adverse event result in any of the following? Doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient been tested for COVID-19?:Yes  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
following hep B vax pt devel a histamine type react-small red welts w/white centers that started on lt arm & then spread to chest fingers & rt arm; resolved by 0600 20SEP;
Patient felt fine on Friday afternoon and evening after shot. Felt fine on Saturday until the afternoon when she started feeling fatigued and chilled. Decided to take a warm bath at about 6pm. Was found dead in bathtub at approximately 7pm with blisters on arms, legs, and face.
Fatigue starting 12 hours after receiving vaccine. 24 hours after vaccine experienced mental fog, joint pain, muscle pain, headache and nausea.
Received call on 10/18/2001 regarding a reaction at site. The injection was given 10/16/2001, client complained of warmth at site, redness and tenderness as well as a bump. Area of redness is about the size of a half dollar. Called 10/19/2001 following heat, swelling is down, redness abating and less tender.
Developed Bell's Palsy 3/5/21 and was hospitalized 3/7/21 for 2 days .
possible central retinal vein ablasion; left eye vision was only like 5% of his vision; severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) (seriousness criterion hospitalization). At the time of the report, RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) had not resolved and HEADACHE (severe headache) was resolving.        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.   No Relevant concomitant medications was reported.  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Excessive menstrual and pelvic pain and major changes to length, duration and frequency of menses ever since the first vaccine dose was received.  These symptoms have worsened over time.
Case number PHEH2015US026856 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 45-year-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event reported following this medication errors. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Patient presented to ED after he became dizzy while shooting pool and felt his defibrillator fire. Patient underwent diagnostic cardiac cath and it was deemed that there would be no intervention at this point. Patient was discharged with plans to follow up with PCP and cardiologist
p/shot 10JAN92 about 3 broke out w/rash few spots; following day hives then the next days swollen mouth ft & hives all over body;
Patient came to clinic to receive Janssen vaccine, after he received the vaccine it was discovered that he had already received a Moderna dose on 3/5/21, Pfizer dose on 3/26/21 and 10/27/21 completing the mRna series and booster. The patient did not have any adverse medical reactions during his time at the clinic (apprx 40 minutes after he was given the injection).
Had a seizure on 1/7/2021 at home - fell to floor face first and became unconscious - seizure activity two different times  a few minutes apart Very nauseated and a severe headache all day prior to seizure
Pt recieved smallpox on 22 Mar 2006. Noticed symptoms a month later. Tightness in chest and difficulty taking deep breaths lasted a week. "Pt has recurrent pericarditis, 5 epsiodes by history in the last two years. Initial trigger may have been viral. Occurred 2-3 months after smallpox vaccination, so not likely to be from that but cannot rule it out. He has ongoing dry cough and ongoing effusion, but symptoms of chest pain have passed. No evidence for tamponade."- 08 Aug 08 doctor visit explanation.
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 66,  via an unspecified route of administration, in the left arm, on Mar 7, 2021, at 15:15, single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease and allergy to penicillin. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 7, 2021, at 15:15, patient experienced very sore arm, especially at site of injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, patient has not tested for COVID-19. The outcome of very sore arm (especially at site of injection): recovering (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660974 with expiration date 20-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported.  On an unknown date, the patient was vaccinated with an improperly stored VAQTA (which had a lot # of R003739 and an expiration date of 16-MAR-2019; however, dose, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: below 32F°/ 0°C (-1.2C) for 21 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved.; Sender's Comments: US-009507513-1807USA006219: US-009507513-1807USA000939: US-009507513-1807USA006221: US-009507513-1807USA006217: US-009507513-1807USA006218:
TINGLING ON ELBOW DOWN TO FINGERS; PAIN IN ARM; This spontaneous report received from a parent concerned a 38 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced tingling on elbow down to fingers. On APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and tingling on elbow down to fingers was not reported. This report was non-serious.
Dizzyness, light-headed, difficulty walking,  Legs feel "asleep" and getting a little worse weekly.  Can't / won't drive - unsafe as feeling in legs is slightly numb.
first vaccination over 4 years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose of Shingles vaccine over 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The patient received only one vaccination over 4 years ago and second vaccination was not available after trying for several months. The patient asked that if a second shot gave him/her protection or did he/she need to start over again.  Additional supportive information; Till the time of reporting, the patient did not receive second shot of Shingles vaccine, which led to incomplete course of vaccination. The case was linked with case US2022AMR144043, reported by same reporter for different patients. The case was kept valid with event incomplete course of vaccination in worst approach as it was not clear that was there any product availability related issue, at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR144043:Same reporter
Started with hurting underneath of left arm, then radiating top of arm, into shoulder with weakness.  Big night tume pain into neck.  Next day pain behind hear and dull headache.  Treatment: observe.
This spontaneous case reported by a consumer, describes the occurrence of aggravated condition (worsening of ocular symptoms/flare-ups), ocular discomfort (ocular symptoms) and pyrexia (fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included multiple sclerosis. Concomitant products included Ocrevus (ocrelizumab) for an unknown indication. On Feb 16, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced aggravated condition (worsening of ocular symptoms/flare-ups), ocular discomfort (ocular symptoms) and pyrexia (fever). At the time of the report, aggravated condition (worsening of ocular symptoms/flare-ups), ocular discomfort (ocular symptoms) and pyrexia (fever) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment information provided.
*NOTE: Unsure of which seasonal influenza vaccine received  Day 1, around 3pm: experienced stomach pain; around 1am, vomited and could not lay flat in bed; vomited a second time during the night and stayed on couch propped up; difficulty standing up fully due to stomach pain; chills and body aches/headache Days 2 and 3: severe stomach pain, chills, body aches/headache continued; lack of appetite; ate jello and chicken broth Day 4: stomach pain started to subside, but ingestion of any food lead to stomach pain For about one week (days 1-7 or 8), diet of only jello and chicken broth For about an additional 3 weeks, diet slowly expanded to include toast, other soups, meats, etc.
On 03-23-2021, 5pm. my symptoms started with chills and lethargic by 530p had chest pain and i felt burning my body and felt restless. The next day i had pain in my kidney area nd rib cage, was  nauseous, my body was still aching, had a bead headaches, had a temperature of 99.87 and my body was so sore. I still had the kidney pain. My fever had jumped to 101.7F. The next day I had fever, chills, dizziness, kidney pain on one side, strange pain under my rib cage and sore teeth and gums. My glands were swelled up in my neck, my taste was a little off. On 3-25-2021, had two large lymph node and my felt I had a ball in my throat.   the pain on my right side, I might had a right kidney stone.  an ultrasound of the right kidney was performed but I do not have the results yet.
Rash within 30 min, itching, treated with oral Benadryl and sent to E.D. per standing orders. BP 142/90. Spoke with Pt 9/18/13, no problems, no further treatment in E.D. 2010-2012 rcvd 3 doses Novartis Flu vaccine.
This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Left arm site of injection -swelling, rash, itch  Called doctors office and they recommended putting ice on location of site for 15 min each hour and taking clariton
Pain was hot and tender; Pain all the way past her elbow; Pain was hot; Pain in the arm; Red arm; Pain where the injection-site occurred; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Pain was hot and tender), PAIN (Pain all the way past her elbow), FEELING HOT (Pain was hot), PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (Red arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039KRDA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced TENDERNESS (Pain was hot and tender), PAIN (Pain all the way past her elbow), FEELING HOT (Pain was hot), PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Pain where the injection-site occurred). At the time of the report, TENDERNESS (Pain was hot and tender), PAIN (Pain all the way past her elbow), FEELING HOT (Pain was hot), PAIN IN EXTREMITY (Pain in the arm), ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Pain where the injection-site occurred) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Regulatory Authority was received Patient's family member stated everything is fine now
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored VAQTA (which had either a lot number of M003011 with expiration date of 15-NOV-2017 or a lot number reported as M021124 with an expiration date of 02-FEB-2018; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
improperly stored doses of VAQTA were administeres to a patient; no adverse affects; This spontaneous report was received from the office manager referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  On an unknown date the patient was vaccinated with a improperly stored hepatitis a vaccine, inactivated (VAQTA) Lot No. S009562 has been verified to be a valid lot number, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019. (Strength, dose, frequency, route of administration, anatomical location, and indication were not reported).  The administered dose of vaccine experienced the temperature excursion of 35.1 degrees Fahrenheit for 5 hours. There was no previous temperature excursion reported. Data logger was involved.
NO SPECIFIC ADVERSE EVENT DUE TO THE VACCINE BUT THE PATIENT PASSED AWAY 02/10/2021 DUE TO COVID
The above patient petted puppies on April 2 and one puppy diagnosed with rabies, patient received her rabies injections April 18. She obtained a prescription for the additional RABAVERT vaccines from our clinic and took the order to the health department where she picked up the vaccine. On April 21 she received her second injection here, the next day she called and reported muscle and body aches, but was advised to continue with the next vaccination. Dose 3 and Dose 4 were scheduled to be given on a Sunday the patient was given an order and the vaccines (on ice and told to immediately return to refrigeration as soon as possible) to be given at an outpatient clinic. On April 25, she was given dose 3, she called us this morning complaining of muscle and joint pain and left sided tingling down leg to her toes. I was told by the Health Department, that it would be in the best interest of the patient to contact Novartis and Sanofi-Pasteur the manufacturers of the rabies vaccines. I did contact each of them and was told that the muscle and joint pain as well as the tingling were side effects and the degree of the severity differs in each individual. I was also told that the injections should not be discontinued due to this individual's symptoms, because the benefits would certainly outway the potential of risk of rabies. The patient will notified of these findings.
tired-lymph nodes swollen in lt ax area; swelling of partotid glands; local red reaction @ inject site; 16JUN93 swelling dec;
Patient received vaccine on May 4th. She was 9 weeks pregnant. In June she had a miscarriage. September 27 pt is admitted to hospital with PE.
Exactly one week after receiving the vaccine, I experienced itching, swelling, redness, and heat at the injection location on my upper left arm.
pt recvd vax & got a rash starting on rt arm either lat 17NOV or 18NOV; rash was red, not raised, petechiae-like & there was little itching;
EMPLOYEE STATES GENERALIZED INCAPACITATING SYMPTOMS. GENERALIZED COMPLAINTS. Narrative:  EMPLOYEE STATES GENERALIZED INCAPACITATING SYMPTOMS RESULTING IN THE INNABILITY TO WORK  Other Relevant History:
Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection site.Headache.
Given hep B injection in left deltoid on 11-15-11. Then the evening of 11-16-11 noticed redness, swelling and itching of (L) deltoid. Seen in clinic 11-17 with baseball sized redness and swelling still itchy, no pain, hot to touch. Given BENADRYL to take as directed until symptoms resolved. To return to clinic if not better.