chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tenderness  and soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness  and soreness at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (Tenderness  and soreness at the injection site). At the time of the report, INJECTION SITE PAIN (Tenderness  and soreness at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
RIGHT DELTOID 7 X 3 1/2 CM AREA OF ERYTHEMA. POSSIBLE LARGE LOCAL REACTION US. EARLY CELLULITIS.
Within an hour, dizziness.  That night, fatigue, pain in arm, bad,bad headache, neck ache. Fever around 100 degrees. Morning after, bad headache, fever over 100 but less than 101. Within 24 hours, headache, shoulder, back, neck ache. Fever with Tylenol 101.6. Sore throat. Possible swollen glands. Waiting to see if better at 48 hrs.
Localized reaction to injection site right thigh. Localized reaction to left vastus lateralis injection site. BENADRYL 3/4 tsp given in office at 9:45AM.
Night sweats first 3 nights after vaccine "extreme fatigue" day after vaccine to present muscle pain since day after vaccine MD diagnosis "arthritis-type vaccine reaction".
low grade fever, joints ache, h/a, nausea;came on suddenly 1hr p/vax given;
After 24 hours, injection site swelled, reddened, itched, hot to touch and was extremely sore in area covering 6 inches by 6 inches.  Pharmacist recommended benadryl. Could not stand to use arm because of swelling and pain.  Five days post injection, the redness has almost disappeared, but the itching and soreness and slight swelling still remain.  Was told by pharmacist this was not abnormal but was unusual.
Had an intussusception 3 days after the Rotateq was given.  Pt did require surgery to reduce it. 12/31/07-records received for DOS 12/13/07-ER visit C/O choking on sputum, coughs up yellowish color sputum. 1/22/08-records received for DOS 12/13-12/16/07-DC DX: Intussusception. Presented with 1 day history of nausea and vomiting.
The initial symptoms were flu-like; elevated temperature; I didn't get to the point that I was having chills but I kept getting really cold. It started aggravating my eczema (I have had eczema since I was a kid). The skin stuff is ongoing. It started on my legs, back of knees and then my inner thighs and then my calves and arms. It's still kind of on my arms (inside my elbow down and up). The doctor had me get compression stockings when my ankle wound was healed and those didn't have cotton on them and they created two spots around my lower legs near both of my ankles and that seemed to all blow up and get more irritated and red and that stuff is just starting to get healed. It's still problematic. They gave me Cephalexin  (that took care of the initial parts that wasn't healing around the ankles) but it was making me itchier). They told me to use Neosporin and polysporin and put a Telfa pad over the wound area. I've been off med that for three week and it's still like an increase eczema symptoms are still around. The doctor is calling it Cellulitis Dermatitis and Venous insufficiency and Eczema is what the doctor is calling it. Also, It's 100 and something degrees temperature outside and I still have times and I feel cold. It doesn't get to the point that my teeth are chattering but it's just an odd feeling.
Initial report was received on 27 October 2011 from a health care professional, at which time this case was assessed as non-serious, listed. Based upon follow-up information received on 16 March 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. The reporter for this case is the same as case number 2011-10458. A 51-year-old female patient received dose one of a right arm intramuscular injection of ADACEL, sanofi pasteur Ltd., lot number C3968 (sanofi pasteur Inc. lot number U4088CA) on 06 October 2011. On 16 October 2011, ten days after vaccination, the patient developed "acute local delayed local reaction" swelling, pain and redness in right arm. She applied ice to site on 17 October 2011 and swelling was decreasing. The patient sought treatment with doctor on 18 October 2011. Vital signs were noted as temperature 97.1 degrees Fahrenheit, pulse 64 beats per minute, blood pressure 124/74, and weight 150 pounds. The patient denied shortness of breath, denied any injury or hitting arm, and denied fever. The patient had right arm pain with abduction and her right upper arm had swelling, was warm and tender, and had redness two and a half centimeters (cm). The patient's energy was noted to be okay (OK), and the rest of the exam was noted to be negative. The patient was diagnosed with Cellulitis and delayed hypersensitivity local reaction, questionably an adverse reaction to ADACEL (Tdap). Treatment included BACTRIM DS twice a day for seven days "BID X 7 d." for right upper arm. The patient was instructed to call if worsens and follow-up in office in one week. The patient's medical history included an allergy to Penicillin and the patient's concomitant medications included multivitamin, nortriptyline, and acetate cream. It was noted that the patient had a negative "C-Scope" with plan to re-scope in five years. The patient had no sex drive and decreased libido. She also took concomitant medication "citalopram 10/day" and was doing "great" and the plan was to "try drug holiday". The patient denied use of tobacco or alcohol. The patient had a two step purified protein derivative (PPD) on (date not reported) that was questionably positive. She had no history of PPD exposure and had a one and a half centimeter (cm) red area (prior to PPD). The doctor requested copy of PPD test results. The patient refused "F.S.". She had elevated low-density lipoprotein (LDL) and elevated high-density lipoprotein (HDL) and was doing great with diet and exercise. Vital Signs on 06 October 2011: temperature 97.0 degrees Fahrenheit, Pulse 60 beats per minute, blood pressure 124/84 mmHg, weight 149 pounds. The patient's outcome was reported as unknown. Documents held by sender: Medical record.
Patient was being observed following his vaccination. The patient stated that he started feeling lightheaded so he got up to let us know. As he was walking toward us, he had a syncopal episode and started to collapse. We were able to catch the patient prior to him hitting the ground. Patient was pale, diaphoretic and hypotensive. The patient was moved to a cot and place in trendellenburg position. The patient was monitored for approximately 30 minutes with vital signs being checked every 5 minutes. The patient's blood pressure increased and his color improved. After 30 minutes the patient stated that he felt better and he was allowed to leave with his wife.
This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with the improperly stored (Oka/Merck) VARIVAX (dose volume, routes of administration, lot numbers were not reported). No adverse effects were reported. Additional information has been requested.
shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number was not reported), via an unspecified route of administration in 2007 as a single dose for immunization. Medical history included cancer survivor and ongoing immunocompromised. The patient's concomitant medications were not reported. The patient experienced shingles in 2007. She took the Prevnar 13 in 2007 and had a really bad reaction that put her in the hospital for 7 days. She had shingles, was in isolation for 4 days. She stated she reported about this. Her doctors didn't think its due to the Prevnar 13 vaccine, but she stated she knew its due to the vaccine as that was the only medication she took per her doctors suggestion. She was started on IVIG after the Prevnar 13. She is cancer survivor, taking IVIG infusion and she is immunocompromised. The outcome of event was unknown.   Information on the batch/lot number has been requested.
Bruising, tender breast, jittery, sweating, heavy and more frequent mensural cycles
On 08/28/2017 at approx. 04:30 PM my voice was becoming hoarse, it felt like there was something in my throat that need to be cleared. At around the same time my vision was getting blurred, I wiped my eyes and noticed that they were filled with something. I went to a bathroom window and saw that both eyes were filled with a yellow pussy discharge. I cleaned them out with water but the discharge built up almost immediately. By 6:30 PM I did not want to get out of my chair. My entire body was feeling weak. At that time I was overcome by chills, cold chills, so severe that I could not stop my entire body from shaking. August, 77 degrees inside. I wrapped myself in a comforter and after a short period began to feel warmer and the SEVERE shaking subsided. I also took my temperature: 100.6. At this point, approx. 6:45 PM while bundled up in my chair my breathing changed to GASPING and at the same time I could feel my heart beating Irregularly. I thought I was going into Cardiac Arrest. I was alone in the house and was too Freaked Out to call 911 although that is what was being recommended by all online sites regarding adverse reactions to flu shot. The gasping and irregular heartbeat seemed to go back to normal within 10 minutes or so. The eye discharge at this tome approx. 7:15PM had begun to improve. I was sitting still in my living room chair wrapped in a comforter until approx. 9:30 PM when I felt that I was going to survive the night and went to bed, still with chills but not nearly as bad as earlier. In the morning I felt somewhat weak, I hadn't eaten anything since the previous morning, had coffee and breakfast and as the day progressed I began to feel 100% again. This was my FIRST FLU SHOT, I will discuss this reaction with my Doctor when I have my annual exam next month.  Please feel free to contact me, via email preferred, if additional details needed.
There was temperature excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up Document received on 15-NOV-2021 contains Patient and Suspect Product details and updated.
Presented to office with complaints of pain, erythema and warmth of injection site left arm.
lymph nodes till feel sore to this day; Sore arm and shoulder/soreness from neck to elbow; headaches for nearly 3 weeks; Sore arm and shoulder/soreness from neck to elbow; Sore arm and shoulder/soreness from neck to elbow; Fatigue for 3 weeks; injection site still itches to this day; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), VACCINATION SITE PRURITUS (injection site still itches to this day), LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy and Drug allergy (allergy to codiene). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Jan-2020 to an unknown date for Stress and Anxiety.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), LYMPH NODE PAIN (lymph nodes till feel sore to this day), ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) and HEADACHE (headaches for nearly 3 weeks). In March 2021, the patient experienced FATIGUE (Fatigue for 3 weeks). In 2021, the patient experienced VACCINATION SITE PRURITUS (injection site still itches to this day). On 31-Mar-2021, HEADACHE (headaches for nearly 3 weeks) had resolved. In 2021, FATIGUE (Fatigue for 3 weeks) had resolved. At the time of the report, NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow) and VACCINATION SITE PRURITUS (injection site still itches to this day) had not resolved and LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication reported. Patients shoulder and arm were extremely sore since first vaccine. shoulder and lymph nodes till feel sore to this day, 19-Aug-2021. It was getting better slowly. When she first got the vaccine it was sore from her neck to elbow to the point she could not touch it for a week. The headaches for nearly 3 weeks. fatigue for 3 weeks  injection site still itches to this day. Patient received the 1st dose on 09-Mar-2021at 01:00 pm.     This case was linked to MOD-2021-079907 (Patient Link).
Vaccine administered was stored greater than thirty days in refrigerated temperature. A case opened with the vaccine manufacturer demonstrated the vaccines were still safe and effective but requested that we make an official report.
On day 8 after the moderna vaccine I woke up with my arm being red, itchy and hot at the injection site.
Patient did not receive second dose in allowed time window; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose in allowed time window) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose in allowed time window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose in allowed time window) had resolved. Not Provided      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 concomitant medications are provided. treatment to the events not reported.  After her specific reaction to the first dose of the vaccine, the patient decided to forgo the second dose of the Moderna COVID-19 vaccine. She is now out of the allowed time window and is not planning on receiving at any point
As described by the mother, the infant was up all night crying after the first set of immunizations. Then the infant developed a red rash on the thighs and lower legs.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 23-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
LEFT GROIN PAIN RADIATING TO THE LEFT LEG/ HARD TO WALK; MUSCLE ACHES; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol hydrochloride. On 10-APR-2021, the subject experienced left groin pain radiating to the left leg/ hard to walk. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, nausea, and fatigue on 11-APR-2021, and had not recovered from left groin pain radiating to the left leg/ hard to walk. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
flush in face, shakiness.  facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent to ED for evaluation and montioring.   BP 141/76  HR 84 02 97
dull pain all the way from shoulder to fingertips. Consistent aching on left side. tingling/numbness in arm and fingertips. Reports not having full function of strength in left hand, can't pick up a gallon of water. Pain is a 5/6 on a scale out of 10, comes and goes. Patient reports going to the ER and was referred to specialist.
This prospective pregnancy case was reported by a physician and described the occurrence of heart murmur in an infant subject of unspecified gender who was exposed to FLUARIX (GlaxoSmithKline) transplacentally when their mother was vaccinated. The infant was also exposed to MACROBID and Ferrous sulfate which the mother took concurrently. On 18 September 2009 at 14:26 the 16-year-old mother of the subject received a dose of FLUARIX (.5 ml, unknown route, right arm). The mother's last menstrual period was on 25 December 2008 and estimated date of delivery was on 01 October 2009. The infant was exposed to FLUARIX during the third trimester. On an unspecified date the infant was delivered by unknown method. Weight and Apgar score were unknown. On an unspecified date the infant was diagnosed with heart murmur and pulmonary complications. No further information was provided. At the time of reporting the outcome of the events was unspecified. Please see case ID A0809375A for details regarding the mother case.
I had a little tickle in my throat, that night I woke up and felt bad I felt like I had a fever. I took a home COIVD-19 test that was positive. I went down to the local hospital and had a PCR COVID-19 test that came positive. I had telehealth with my Asthma doctor who put me on steroids and an antibiotic. I still have some coughing but no temperature, a little fatigue,
immunocompromised patient received half third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received half third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included INFLIXIMAB (REMICADE) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received half third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received half third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. The patient is immunocompromised.
Question 5: Moderna monovalent booster administered prior to receiving information to stop giving. Client contacted and no adverse signs or symptoms have occurred as of this time.
Cardiac arrest one week later, on 03Mar died 3 months later; Cardiac arrest one week later, on 03Mar died 3 months later; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 02:00 (at the age of 73-years-old) (Batch/Lot Number: En6302) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. The patient did not have covid prior vaccination and was not covid tested post vaccination. On 03Mar2021 07:00, the patient experienced cardiac arrest one week later, on 03Mar2021 died 3 months later. Therapeutic measures were taken as a result of the events. The patient died on 03Mar2021.  It was not reported if an autopsy was performed. The outcome of the event cardiac arrest was not recovered.   Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest one week later, on 03Mar died 3 months later