chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ARM SWOLLEN WHERE PATIENT GOT THE VACCINE; ARM SORE; MAJOR HEADACHE; NAUSEA; TIREDNESS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-AUG-2021, the subject experienced arm swollen where subject got the vaccine. On 04-AUG-2021, the subject experienced arm sore. On 04-AUG-2021, the subject experienced major headache. On 04-AUG-2021, the subject experienced nausea. On 04-AUG-2021, the subject experienced tiredness. On 04-AUG-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm swollen where patient got the vaccine, major headache, nausea, tiredness, fever and arm sore was not reported. This report was non-serious.
Employee Health nurse gave Varicella vaccine, dose #2, per CDC recommendations for healthcare personnel.  Healthcare worker, patient, developed raised, red, swollen, very painful area, max measurement was approximately 7x15cm.  PA-C, prescribed 5 day course of Keflex for possible cellulitis.  Reaction improved tremendously after 2nd dose of Keflex.
23JUN94 woke up w/severe diarrhea, nausea, h/a, & vomiting x 4 over a 2 day period; 24JUn & 25JUN states t100.5; on 26JUN & 27JUN sx dec exp somee nausea & sm amt diarrhea; 28JUn states diarrhea inc; 5JUL94 returned to work,
1APR97 pt started rnning t103 approx 2hr p/vax;also started vomiting & having diarrhea;approx 24hr p/vax hosp for 6hr d/t dehydration;rechecked @ clinic approx 48hr p/ d/c-doing well;
Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and then left. She states on her way home she started feeling that her tongue and left side of her face was a little bit numb. It continues to be numb and on examination the left side of her face has diminished sensation. Her left eye is droopy and she has a symmetrical eyebrow raises as well as smile. Her diagnosis is consistent with possible Bell's palsy.
MYOCARDITIS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211157170-COVID-19 VACCINE AD26.COV2.S-Myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
pt recvd vax & exp low grade temp on 22AUG95 & early in day 23AUG95 temp inc to 104 & pt had sz;911 was noticed & child brought to ER & adm mostly for observation; bloodwork, CXR; dx MMR rxn
Vaccine administered about 10:30 am. About 3:30-4 pm, she turned pale, limp, collapsed, lips blue, no tone which lasted 2-3 min per parents-911 called and brought her to hospital. Admitted for observation and had normal EKG, cardiac ECHO, EEG and labs. No further episodes and D/C the next day.
I had vaccination on 09/20/2022. On 01/24/2023 I had nasal congestion low grade fever and felt cold all day. I took a COVID-19 test Positive and contacted my doctor office. I was prescribed Paxlovid. I currently feel fine on 03/30/2023.
On 4/19/2022 I developed a sore throat about 4:30PM. The next day  when I woke up I had a headache and a fever as well. I scheduled a COVID-19 test and by non on 04/20/2022 I had a positive COVID-19 result. On 04/21/2022 I had a virtual visit to discuss treatment for COVID-19. It was decided that my only option was to do the antibody infusion. I had the infusion at a different facility on 04/22/2022. When I woke up on 04/23/2022 the sore throat, fever, headache and muscle aches were gone. I did have a continuation of severe nausea for about two weeks but never threw up. I still get tired more easily than normal but other than that I feel fine now.
Client received the 2nd COVID vaccine of Moderna (Lot# 021C21A expiration 05/26/21). Client has completed 10 minutes in the observation room before reporting an outbreak of hives on her left arm at 1344. Client is accompanied by husband. At 1344, EMT responded and notified RN and PHN. Client reports no adverse effects with the 1st dose of COVID vaccine of Moderna. At 1344, vital signs are blood pressure 130/72, heart rate 92, oxygen saturation 98%. PHN educated Client in regards to ED precautions and common adverse effects of the COVID vaccine. PHN offered 50 mg of Benadryl by mouth. Client accepted 50 mg of Benadryl by mouth. At 1346, 50 mg of Benadryl by mouth was administered to Client. Client was advised to stay in the observation area for an addition 30 minutes. Client agreed. Client was offered supplemental nutrition and fluids. Client denied nutrition, but accepted water and juice. Visible hives are present on left arm, right forearm, and right clavicle. At 1352, vital signs are blood pressure 132/78, heart rate 84, oxygen saturation 98%. Client reports no headache, no shortness of breath, no tightness in the throat, no chest pain, no blurred vision, no nausea. Client reports a history of diabetes type 2 and osteoporosis. Client reports taking medication: Metformin, Benazepril, and vitamin supplements. Client has allergies to Penicillin, shellfish, and iodine. At 1402, vital signs are blood pressure 120/73, heart rate 79, oxygen saturation 98%. Client reports no new symptoms. Hives on the right forearm are lightening up and skin tone is returning back to appropriate coloration to ethnicity. Hives on the left arm and right clavicle are still present, but have lightened to a pink coloration from red. At 1412, vital signs are blood pressure 130/78, heart rate 77, oxygen saturation 96%. Client reports no new symptoms and is talking with EMT. At 1422, vital signs are blood pressure 120/70, heart rate 77, oxygen saturation 96%. Client reports no new symptoms. At 1432, vital signs are blood pressure 130/72, heart rate 80, oxygen saturation 97%. Client reports no new symptoms, talking to EMT and husband. At 1442, vital signs are blood pressure 120/70, heart rate 76, oxygen saturation 96%. Client reports no new symptoms. At 1445, hives have significantly lightened and have gone down, but are visibly present only on the left arm. Client reports no itching and is reminded of ED precautions. At this moment, Client reports feeling "a little tired". At 1450, Client reports no new symptoms and leaves facility. Client stood up with no complaints and walked out with a steady gait accompanied by husband.
A temperature excursion for PNEUMOVAX 23; No further AE.; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, route, dose, frequency, and anatomical location were unknown) with lot # T026156, and expiration date 22-MAY-2022 for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 49.3 degrees Fahrenheit for 1 hour 0 minutes 0 seconds, and had no previous temperature excursion. There was a digital data logger involved. No further adverse event information provided.
Arm pain and fatigue about an hour after. Increase in menstrual flow. I passed 15+ grams of blood in roughly 4 hours which is abnormal for me.
Fever; Tingling all along fingers and hands; Body aches; Arm sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), PARAESTHESIA (Tingling all along fingers and hands), MYALGIA (Body aches) and PAIN IN EXTREMITY (Arm sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), PARAESTHESIA (Tingling all along fingers and hands), MYALGIA (Body aches) and PAIN IN EXTREMITY (Arm sore). At the time of the report, PYREXIA (Fever), PARAESTHESIA (Tingling all along fingers and hands), MYALGIA (Body aches) and PAIN IN EXTREMITY (Arm sore) 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.   Treatment and concomitant medications were not provided by reporter.
BLOOD CLOT SYMPTOMS; VERY BAD SIDE EFFECTS; This spontaneous report received from a patient via monitoring through company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, and batch number: unknown, Expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, Expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced very bad side effects (captured as: adverse drug reaction NOS), and ended up in Emergency room (ER) with blood clot symptoms (events subsumed under blood clot symptoms) (Dose number in series 2). As per the report "I got my second dose of the #johnsonandjohnson vaccine got very bad side effects, ended up in the ER with blood clot symptoms and these are my bills! Who's paying for this horrible side effects? Us? No way! Outrageous!" No additional information was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot symptoms and very bad side effects (adverse drug reaction NOS) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211218623-covid-19 vaccine ad26.cov2.s-Blood clot symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Rashes; Hives; Itching; Headache; Fever; This is a spontaneous report from a contactable consumer (mother) reported for her daughter. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and reported that there is no reaction on previous exposure to vaccine. On 16May2021, the patient experienced rashes, hives, itching, headache, and fever (Reporter as the daughter's adverse events started on 16May2021). Caller wanted to know if these adverse events may be from the vaccine. She also wanted to know if other people have experienced their adverse events from the vaccine. The outcome of the events was reported as unknown. No PQC involved.   No follow-up attempts are possible. No further information is expected.
Pt reported that she experienced, at first, the usual SE of headache, fever, fatigue, chills for about 2 days, but on 3rd day noted an 85% Pulse-ox reading and chest pains. A trip to the ER revealed a heart attack. Pt wanted us to know so that we could report it.
PATIENT COMPLAINED OF ARM BEING SWELLED AND ITCHING. OTHERWISE SHE DIDN'T EXPERIENCE ANY OTHER SYMPTOMS. THE REACTION OCCURED 5 HOURS AFTER THE VACCINE WAS GIVEN, SHE WAS ADVISED TO APPLY ICE ON THE AFFECTED AREA AND TO FOLLOW UP IF DOESN'T RESOLVE.
Head and ear Shingles from 1st shot; This case was reported by a consumer via and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as dollows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, less than 2 weeks after shot, had got head and ear Shingles. The patient was nervous about getting the 2nd shot.
Rash appeared 2 days after receiving the flu shot. Rash is getting better slowly after 2 weeks. Pt had HD flu vaccine and had no problem.
The residential facility called and stated taht the patient received Moderna for the first 3 vaccines and then received Pfizer for his 4th dose. The patient was feeling flu-like symptoms.
Rash started on 4/2/02. Not as active, low-grade fever, acts ill but not toxic. Observe.
Information has been received from a healthcare worker (medical assistant) referring to an adult patient of unknown gender. The patient's medical history or concurrent condition were not provided. On an unknown date the adult patient was inadvertently administered a dose of pediatric RECOMBIVAX HB (injection, lot#, dose, route and therapy type were unspecified) (incorrect dose administered), then 10 days later was administered a 2nd dose of pediatric RECOMBIVAX HB (injection, lot#, dose, route were unspecified) (incorrect dose administered and inappropriate schedule of vaccine administered). No adverse effect reported. Additional information has been requested.
Arm started to swell from elbow to shoulder, turned very red, then by the morning of 9/29/2010 swollen twice my normal size and very red under arm and entire upper arm very hot from elbow to neck.  Went back to clinic told to take ibuprofen and ice it, no change as of 9/29/2010 11 AM.
Fever, lethargic, Headache  6 days later, swelling and large red rash on arm and face.  Mild throat swelling or irritation
Headache, chills, body aches, sweating, nausea. Also, currently nursing and my milk supply has significantly decreased.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 29.  Concomitant products were not provided.  On 28-Apr-2021, Excursion time was 9 AM, temperature was 33, total doses given for the day was 150, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-Apr-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 PM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
mom described sz like acitivty the evening p/vax; this is reported on 25SEP95 during visit for dermatitis
malaise, arthralgias requiring tylenol, lasting at this time 4 weeks with mildly elevated CRP and D-dimer
redness surrounding inject site, warm to touch, minor discomfort; inc redness & heat;
Rash chest and face. Face and throat swelling. Difficulty swallowing.  Taken to ER and given steroid, benadryl, and pepcid. Systemic affects x3 days. Medications given for a total of 5 days.
Headache, Sedation, Myalgia, Arthralgia, Chills Narrative:
hard knot deep inside rt deltoid area x 2 inches; soreness lt p/2 wks then numbness & tingling started & has remained; numbness extends down arm into hand; feels like had temp but it wasn't taken;
Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint ache Fatigue Headache Took two Tylenol which brought fever down and slept. Took two more Tylenol at bedtime and felt normal the following morning.
Information has been received from a consumer concerning her daughter an 1 year old female patient with seasonal allergy who in April 2006, was vaccinated SQ with a dose of VARIVAX (Merck) (dose and lot number not reported).  The consumer reported that the patient broke out with blister like a rash in 2006.  The patient recovered but then she broke out again in 2009.   Both cases were "mild".  At the time of the report the outcome of the adverse events in 2009 were unknown.  The patient did not seek medical attention.
All at 2pm - - headache, chills, fever, muscle aches, tearing in left eye, slight burning in left eye, extreme fatigue  All symptoms got progressively worse as time passed.
Pt arrives via ems from home. His son (caregiver) has been sick with covid for two weeks and has been away from home. Since his son hasn't been able to care for him the Patient states that he feels like he can no longer care for himself. Increasingly weak. This is a 87 yo male who presented to the ED with c/o of generalized weakness, decreased PO intake.  He has a PMHx as listed. Apparently his son tested positive for COVID about 10-14 days ago, typically his son lives with him and cares for him but he has been staying elsewhere while he recovers. Since his son has been out he has not really been able to care for himself as well. Over the last 5 days has had progressive weakness, decreased PO intake, increased PO intake. Still in hospital on 01/17/2022 in COVID Stepdown unit.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: redness at site too low-Mild, Systemic: Joint Pain-Mild, Additional Details: redness at site
Approximately 15 minutes after vaccination, stated she felt hot and flush. Given 20mg of Benadryl and given juice. Moved to an area she was able to take her mask off and take deep breaths. Denied any SOB or throat concerns. 5 minutes later stated she still felt hot and flush and felt as if she were going to throw up. Given another dose of Benadryl 20mg at this time. Approximately 8 minutes later stated she was doing okay, but still a little warm but felt the room was warm. Opened window and she sat by the window for approximately 4 minutes. At this time stated she felt better and wanted to return to work.
Numb arm, severe pain, couldn't lift the arm by itself had to assist with the other arm. Couldn't allow the arm to touch my body or anything else. Had to wedge a pillow between my body and my arm for comfort. No treatment was given. Was told that it would go away by itself in a day on two. Still have issues with sharp pain in shoulder joint and muscle spasms in the muscle where shot was given.
06/13/2013 Ulcers and sores in mouth. 07/16 Emergency Room Swollen Lips. Severe Rash all over body. Blister on right hand and Penis. 09/03/2013 Lips swollen sores in mouth Severe Rash. 09/07/2013 Follow up Doctor visit.  09/11 Allergist. 09/28/2013 Reoccurence Severe Rash Blisters in mouth. 10/01/2013 Infectious desease Doctor. 10/02/2013 Dermatologist. 10/19  Reoccurence same syptoms Reoccurence Severe Rash