chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm was also fairly sore/Body is bad; fever went up to 99 to a 100, or 101; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Her arm was also fairly sore/Body is bad) and PYREXIA (fever went up to 99 to a 100, or 101) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893 and X51621A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced MYALGIA (Her arm was also fairly sore/Body is bad) and PYREXIA (fever went up to 99 to a 100, or 101). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at a dose of 1 dosage form every four hours. On 26-Jul-2021, PYREXIA (fever went up to 99 to a 100, or 101) had resolved. At the time of the report, MYALGIA (Her arm was also fairly sore/Body is bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, Body temperature: 99-101 (High) fever 99-101.         No concomitant medications were provided.   This case was linked to MOD-2021-244794 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received contained: Updated event outcome
pain on his arm; lost range of motion in his left shoulder; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on his arm), JOINT RANGE OF MOTION DECREASED (lost range of motion in his left shoulder) and PYREXIA (fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016321a and 020b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PYREXIA (fever). In May 2021, the patient experienced PAIN IN EXTREMITY (pain on his arm) and JOINT RANGE OF MOTION DECREASED (lost range of motion in his left shoulder). On 26-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (pain on his arm) and JOINT RANGE OF MOTION DECREASED (lost range of motion in his left shoulder) had not resolved.            No concomitant medication reported. No treatment medication reported.
Monday morning I woke up with a scratchy throat, but didn't think too much of it because of the season. On Tuesday I still had the sore throat and then started sneezing. My son had issues with sneezing the week before so I thought it was a cold or something from him. On Wednesday I was feeling fatigued so I took a COVID-19 rapid test at home and it was negative. Then on Thursday I had a fever, and started reconsidering it. On Friday I took another at home COVID-19 and it was positive. I went to the urgent care and they gave me another test, also positive. She gave me a prescription for PAXLOVID tablets. I took the 5 day course alongside cold and flu medicine to help with symptoms. It was a mild thing, it was more like a cold other than the fever that one day. By the 10 day mark it was pretty much over, just an occasional cough. My son's symptoms were even more mild than mine.
soreness the day of the vaccine but no other symptoms since; Received the Pfizer COVID-19 Vaccine Gray Cap Monovalent today, but the vaccine had an expiry date of 30Nov2022; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2022 as dose number unknown, single (Lot number: FP7140, Expiration Date: 30Nov2022) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 02Dec2022, outcome "unknown", described as "Received the Pfizer COVID-19 Vaccine Gray Cap Monovalent today, but the vaccine had an expiry date of 30Nov2022"; PAIN (non-serious) with onset 02Dec2022, outcome "unknown", described as "soreness the day of the vaccine but no other symptoms since".  Additional Information: Reporter said they normally go based on the 10 weeks time period but unfortunately since the manufacturer expired first, they were told by the guidelines to use that instead of being normal 10 week period which would have made 11Jan2023. The correct expiration date was 30Nov2022. The expiration was 12 months after the manufacturing date. It had been stored in a regular refrigerator within recommended range. Reporter confirmed the product is the monovalent gray cap formulation, primary series for the patient.
Redness, tenderness, sore at injection site. Chills, body ache.
Per patient she developed a skin nodule at the injection site 1-2 days after receiving the immunization. Patient came in for the issue on 06/01/2023. The skin nodule is quarter coin-sized that is raised and red. Hard to touch. Patient stated it feels sore when she touches it. Instructed patient to see the primary physician as soon as possible and follow up with us.
Arm was itchy and little pustules developed on both arms.  No rash on chest or trunk.  Mom states he is acting "hyperactive" and complained that one eye was "fuzzy".
This spontaneous report as received from a pharmacist who read the case report from the National Vaccine Information Center refers to a 64 year old female patient with hives from horse serum. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). The following day, the patient had a very dehabilitating adverse reaction, which was unspecified. The outcome of the event was unknown. Additional information has been requested.
11/14/07 (-) Fever, (L) arm-site of injection-Red/warm/swollen- Rx Clobetasol Cream BID 11/15/07 TC prompt-states she feels weak/shakey + having heart palpitations-went to ER-Hospitalized overnight.  12/28/07 Reviewed hospital medical records which reveal patient experienced symptomatic palpitations with lightheadedness, fatigue, DOE & nausea since 11/12/07.  Also had a local reaction to vax.  Admitted 11/15-11/16/2007.  Remained stable & d/c to home w/f/u troponin to be obtained as outpatient. FINAL DX: symptomatic sinus tachycardia.
PT CALLED TODAY (5/9/21) TO ASK IF HE WAS HAVING A NORMAL REACTION.  HE THEN STATED HE HAD A RASH ALL OVER INCLUDING HIS FACE AND INSIDE HIS MOUTH, EVERYTHING HURTS, AND HIS FEET WERE SWELLING.  I INFORMED HIM TO GO TO THE HOSPITAL IMMEDIATELY.
May be allergies; Dizzy; Arm hurt real bad; Very weak; weak/sick/I got really sick; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt real bad), ASTHENIA (Very weak), ILLNESS (weak/sick/I got really sick) and HYPERSENSITIVITY (May be allergies) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ1B and 011AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes, Lupus erythematosus, Latex allergy, Penicillin allergy, Allergy to antibiotic (Amoxicillin) and Fish allergy. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE BESILATE (AMLODIPINE BESYLATE 10) and ATORVASTATIN for an unknown indication.   On 06-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt real bad), ASTHENIA (Very weak) and ILLNESS (weak/sick/I got really sick). On 15-Apr-2021, the patient experienced HYPERSENSITIVITY (May be allergies). At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm hurt real bad), ASTHENIA (Very weak), ILLNESS (weak/sick/I got really sick) and HYPERSENSITIVITY (May be allergies) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-237235 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up 2: Patient allergies and relevant history added. Start time of Moderna vaccine updated. Event onset date updated. Event added.
Pain left arm and shoulder, high fever for one week, cough, sneezing, vomiting, pneumonia (3/11/22)
On Tuesday I developed a raised itchy welt on my left deltoid that was approximately 2 inches long and 1/2 inch wide and was red and warm to the touch. By Wednesday it had spread to an area about 4 inches long and 2 inches wide. By Thursday the area from the top of my deltoid to my elbow was red and itchy and warm. By Friday it was past my elbow.  By Saturday it was my entire arm from the deltoid to my wrist and in addition to the itchy red patches on Saturday night my arm was swelling so much that my elbow was no longer visible. By Sunday my arm was swollen to almost double the size.  As I was on a cruise ship, I went to the medical center and was given 2.5% hydrocortizone cream and an injection of steroid.
Information has been received from a physician concerning a 16 year old male who on 18-OCT-2010 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, unspecified arm. There was no concomitant medication, medical history, drug reactions or allergies. On 21-DEC-2010 the patient was seen at the office with right side gynecomastia, and right side swelling and tenderness of muscles in the chest and back. On the same date, 21-DEC-2010 the second dose of GARDASIL was administered in the left arm. At the time of report, the patient's symptoms were persisting; he was treated with ibuprofen as needed. Physician states many laboratory tests performed such as CBC, Chest CT, CPK, and all with normal results except for gynecomastia. Follow up information has been received from the physician and stated that after further examination, the patient was provisionally diagnosed of gynaecomastia. He referred to endocrinologist from whom he had not received consult report. Additional information is not expected.
Possibly inadvertently injected with empty syringe with J&J vaccine and Ml vanish point syringe
Erythema > 3in on 3/5/16 grew to include lower part of upper arm from elbow to axilla by 3/12/16.
One-half tongue swelled - Noticed about 4 AM 1/22/2010 - Self treated with BENADRYL - Patient reported with no complaints
Severe soreness around injection site about the size of a softball lasting approximately 24-36 hours.
Patient contacted the pharmacy on next day around 10:12 am and stated about one hour after vaccine administered she started experiencing  shills, ache all over the body, fever 102 F lasted only one night, she was not febrile next day on 12/9/2020. on 12/9/2020 she reported that body pain not as bad as before, she had stomach upset on 12/8/2020, no appetite, sick stomach, nausea and vomiting on 12/8/2020, which she feels fine on 12/9/2020, no nausea and vomiting, and she was able to take some Tylenol on 12/9/2020
a fever for a number of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Caller adds that she got all the covid vaccines, they were all Pfizer,), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE , Caller adds that she got all the covid vaccines, they were all Pfizer,), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Caller adds that she got all the covid vaccines, they were all Pfizer,), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "a fever for a number of days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller adds that she got all the covid vaccines, they were all Pfizer, and the 4th one, clarifying the second booster, that gave her a fever for a number of days. When probed if she had dates, lot numbers, and expiry dates of all her covid vaccines, caller again stated that she prefers to provide this information on follow up, she was sure this information. Caller asked is it common that one can have a fever as a side effect. Caller declined transfer , stating that she was informed on how to get to the website, and look at it. Caller asked for drug safety's email to provide product details. Caller was informed that she would have to wait for follow up with her. Caller stated to not send her any physical mail, caller states that she would like to be contacted by Email.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A follow up report received 8/14/2000 adds: Large local reaction 8.5 x 5cm after 2nd shot. Physician considered local reaction. Case closed.
Spotting between periods in the form of clots. Day 16 of cycle. Cramps.
PATIENT GOT THE FIRST SHOT ON 04-19-21 AND IS TODAY RECEIVING THE SECOND SHOT MORE THAN SIX WEEKS AFTER THE FIRST SHOT
microscopic lymphocytic colitis; This is a literature report for the following literature source(s).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gastro esophageal reflux disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunization. The following information was reported: COLITIS MICROSCOPIC (medically significant), outcome "recovered", described as "microscopic lymphocytic colitis". The patient underwent the following laboratory tests and procedures: C-reactive protein: Normal; Endoscopy: patchy erythema in the descending colon, notes: and rectosigmoid; Mucosal evaluation: lymphocytic colitis; White blood cell count: Normal. Therapeutic measures were taken as a result of colitis microscopic.; Sender's Comments: Based on the information in the case, an association between the reported event Microscopic Colitis and the suspect product bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
gland under his left arm is really swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 10:00 (Lot number: Unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLOPIDOGREL. Vaccination history included: Bnt162b2 (Dose 1, TIME: 10:00AM, Action taken-Unknown, Anatomical location-Left Arm), administration date: 23Mar2021, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Apr2021, outcome "unknown", described as "gland under his left arm is really swollen".  Additional information: The patient was taking Covid 19 Vaccine (Verbatim): prevent covid, works for power company. The patient took clopidogrel: quite a few years, maybe 7 years. Reported was calling about the Covid 19 vaccine. Reporter was calling for her husband. He had his second Covid 19 vaccine on Tuesday, 13Apr2021. The gland under his arm, in the same arm he received his vaccine, was really swollen. Clarified left arm. Reporter called to ask if this was a side effect of the Covid 19 vaccine. The patient did not have prior Vaccinations (within 4 weeks) no AE(s) following prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given a dose of the vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial) 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. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-268121 (Patient Link).
Twenty-four hours after the second vaccination, I got extremely tired, abnormally tired. I slept for almost the whole day and slept the next day. I tried to keep going, and I took Tylenol. For two months, I ended up taking naps every day. I would just nap for 1-2 hours every day. That's when I finally went to the doctor to say something about it because I was thinking that it was the shot. I went to my doctor to just make sure that it wasn't something like my blood pressure being off, but that was fine. She checked my blood sugar and that was the best it had been in years. I also got my thyroid levels checked and they were fine too. I told her that at that point, I wasn't sleeping as much, but it worried me that I was sleeping a lot. My doctor changed my thyroid medicine from 6 days to 7 days. After 3 months, I was feeling fine. It was very frustrating though to wake up a little bit late, go for a couple hours, then having to take another nap. It was just real tiredness for me.
I started having post-prandial tachycardia and dizzy episodes. Then progressed to bilateral arm weakness, legs were preserved. Loss of upper extremity reflexes. Severe fatigue and generalized weakness.  Headaches. Photophobia and photophobia. Intolerance to flashing lights and anything that required saccadic eye movements. Fine tremor.
On February 8th  her right shoulder and left hip is swollen is very painful. Body feels tense and the pain comes and goes. Doctor sent her to a spinal specialist on March 10th but still couldn't find anything. Right hip had gotten worse she had to stop working and could barely walk. On march 29th her doctor prescribed her gabapentin and ropinirole. On April 23rd got an injection in her right hip.
Immediately after receiving immunization - (R) deltoid became red, swollen at site of MENVEO, (R) side of face red with some spot. Pt txd with BENADRYL and SOLU-MEDROL and observed.
Pt recieved a 3rd (accidental) administation dose of Shingrix: staff believed it to be th e2nd injection as the actual 1st injection was administered at the Dr Office, thus, the information on that injection was not in the pharmacy's patient record; patient stated that he has never had any reaction to previouly administered vaccinations.
Almost fainted/sleepiness 02 @ 3L per mask, R32, P86reg, color gray, dizzy & fever upon returning home;
-102.4 F fever that responded to ibuprofen.  Lasted 3 days -mild insomnia that also lasted 3 days -body aches lasting 3 days -sore arm lasted 7 days -heavy menstrual cycle (6 oz in 24 hours) started 2 weeks after injection, lasted 7 days although the flow decreased over the week. Should not have had my period as I am on the pill.  This occurred for 2 months and I appear to be back to normal.  -Was breastfeeding my 13 month old at the time and he was irritable and unable to sleep starting about  24 hours after my injection, and this lasted 3 days.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies were reported. On 30-SEP-2015, the patient was vaccinated with extra doses of MMR II (strength, dose, lot # and expiration date were not provided) and (Merck) VARIVAX (strength, dose, lot # and expiration date were not provided). The past doses of MMR II were administered on 01-FEB-2011, 04-MAY-2011 and 01-NOV-2011. The past doses of (Merck) VARIVAX were administered on 07-NOV-2013 and 25-FEB-2014. No adverse effects were reported. Additional information has been requested.
This spontaneous report  as received from a healthcare worker refers to a male patient of unknown age with penicillin allergy, LORABID allergy and OMNICEF allergy. No pertinent medical history was reported. On 22-AUG-2013 the patient was vaccinated with GARDASIL (lot # was reported as J006736, expiration date February 2016), intramuscular. No concomitant medication included. On an unknown date the patient experienced sweating, after receiving GARDASIL. The patient sought medical attention via office visit on an unspecified date. No treatment was given. No lab diagnostic studies performed. Therapy was reported as continued. The event outcome was reported as recovered. It was also reported adverse event reappeared after Reintroduction. Additional information has been requested.
About a year ago I caught my first ever Flu from a co-worker. Back then after a few days of having high temperature, nausea and headache accompanied with cough and runny nose I developed tinnitus in my right ear. It lasted about a week before it started fading but then new symptom in the same ear happened. Change in pitch of sounds that I heard. Slowly over the course of about another 1 to 2 weeks all symptoms in my Right ear went away but before that happened I developed same issue in my left ear too. Eventually after about 3 weeks most flu symptoms vanished and tinnitus also went away after about a month to a month and a half. Yesterday (November 25th 2017) I got my flu shot at a pharmacy. Now a few hour after getting the shot (maybe about 5 hours later). I have same symptoms I had with the actual flu when it comes to my ears only. No high fever, no coughing no runny nose small headache but accompanied with tinnitus in my right ear (again).
Immediately following the vaccine he developed a localized area of swelling, which they marked with a black pen and didn't expand. Documented on 02/21/19: Then approximately 48 hours ago he developed an area of redness near the area of his vaccine reaction, that he described as "itchy". The next day, 2/20/19, he developed a low grade temp of 100 degrees, and then today developed temp to 102 degrees, a headache and now a runny nose.