chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches occurring in the legs, along with worse lumps that are undiagnosed appearing to be blood clots in the legs; muscle aches occurring in the legs, along with worse lumps that are undiagnosed appearing to be blood clots in the legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2577013 (Genentech, Inc). A 79 year-old female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Melanoma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "2 Bad heart valves" (unspecified if ongoing); "Aortic insufficiency" (unspecified if ongoing); "Pancreatitis" (unspecified if ongoing); "Brain tumor" (unspecified if ongoing); "stage 1 Bronchioloalveolar carcinoma" (unspecified if ongoing); "stage 4 Bronchioloalveolar carcinoma" (unspecified if ongoing); "metastasis into both lungs" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing); "thyroid obliterated" (unspecified if ongoing); "irregular heart beat" (unspecified if ongoing); "appendix removed" (unspecified if ongoing); "lung cancer surgery" (unspecified if ongoing); "benign meningioma surgery" (unspecified if ongoing); "Brain tumor" (unspecified if ongoing); "Lobectomy" (unspecified if ongoing); "Lung inflammation" (unspecified if ongoing); "Chronic bronchitis" (unspecified if ongoing). Concomitant medication(s) included: TARCEVA. Past drug history included: Levothyroxine sodium, reaction(s): "Allergy". The following information was reported: THROMBOSIS (medically significant), MYALGIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "muscle aches occurring in the legs, along with worse lumps that are undiagnosed appearing to be blood clots in the legs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 9 week old patient, who was vaccinated with improperly stored doses of RECOMBIVAX HB and ROTATEQ (lot # L046319, expiry date: 28-SEP-2017, dose and route of administration were not reported) on 16-AUG-2016. Reporting nurse did know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012794: US-009507513-1608USA012908: Original case: 1608USA012916 US-009507513-1705USA004965: US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004953: Original Case: 1608USA012916 US-009507513-1705USA004952: Original case 1608USA012916 US-009507513-1705USA004967: US-009507513-1705USA004954:
Pfizer Covid vaccine lot EH9899 on 12/21/2020, 1430hrs   12/31/2020 1400-2200hrs: Ocular watering, itching, discomfort. No treatment. (no alcohol, no celebration, ill feeling) 01/01/2021, 0900 - 2230hrs: Fatigue, photophobia, headache 8/10 pain, clear nasal discharge. Profound feeling of something entering at cribriform plate. Frightening & disturbing. 01/02/2021 0030hrs: headache 4/10 pain, eyes feel dry / sore.
Muscle Pain, Joint Pain, Trouble Concentrating, Headaches, Fatigue, Depression, Anxiety, Sleep Apnea. Muscle and Joint Pain first to appear. All symptoms have increased over time.
Patient states pain in right arm that started after receiving H1N1 vaccination. Patient states pain initially felt "like a shot" but became worse in the evening. Patient states she woke up with pain in her arm and took Tylenol. She reported the pain two weeks post vaccination, stating she went golfing and felt pain when she tried to swing the golf club. Employee states she reported it because the pain had not gone away. She has limited ROM of her right arm - pain with lifting perpendicular to floor and when extending arm forward. She states it is starting to get better. The patient was advised to call her PMD on 01-27-2010 when she first called about this reaction. She states she did call her physician on 01-29-2010, after being advised again, and is waiting to hear back from him.
When I initially received the shot with in 15 minutes my pointer finger on my right hand became stiff and swollen. The following week, I experienced headache & neck soreness - approximately 7 days after the vaccine. On Friday, I went to the see my doctor for for abdominal pain on my left side. I was diagnosed with Diverticulitis. I was able to take medication and required no hospitalization.  Once on meds the swelling and stiffness in my finger subside but returned once meds were stopped. I assume this was due to the anti-inflammatory effect from antibiotic. Please note, I received a full check up and blood work two weeks prior to getting my vaccine. I have had diverticulitis twice before: First occurance: 8/18 - hospitalized 4 day , Second occurance: 4/19 - meds only / no hospitalization. I believe the vaccine caused extreme inflammation in my body and
- loss of appetite  - fatigue (slept much more) = still feeling that way, but seems to be gradually improving  - chills and hot flashes = still feeling this way, but gradually improving  - feels like they started going away last Wednesday 4/8/20, starting having an improved appetite at that time  - diarrhea worsened after the vaccine, still having this symptom, and gradually improving
Shingles rash along left C5-C6 dermatome. Treated with Valacyclovir and prednisone. Currently ongoing.
pt recvd vax & devel rash on Lt leg from knee to top of thigh; leg was swollen 3x norm; t 104; 2 days later t 103; given APAP & ATB for eye infect
This case was reported by a lawyer and described the occurrence of neurological damage in a male subject who was vaccinated with hepatitis B vaccine and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records: The subject received hepatitis B vaccinations on 2/21/95, 4/26/95 and 8/23/95. The subject was also vaccinated with Haemophilus influenza type B vaccine, a separate injection of poliomyelitis virus vaccine, and DTP/DTaP. The subject's 37 year old mother had a spontaneous vaginal delivery at 40 weeks and 6 days following an uncomplicated pregnancy. The infant weighed 9 pounds and 2 ounces. Apgar were 8 and 9. Physical examination at the hospital was unremarkable. On 12/16/03, he was evaluated by a physician who noted that the subject was previously diagnosed with autism and mental retardation after an evaluation overseas. He moved back to his home country when he was approximately 5 years old. He began having difficulties with aggressive behavior. This prompted his parents to clarify the diagnosis. Aggressive behavior has abated but the subject still has difficulty with poor frustration tolerance and becomes easily upset with transitions and changes in routine. It was reported that his primary physician became concerned at approximately 3 years of age because he didn't have enough language with little vocabulary and no speaking in phrases or sentences. He began walking at 15 months of age and has had long standing difficulty with both gross motor and fine motor skills. Examination of cranial nerves revealed visual fields to be intact. Motor examination revealed normal and symmetric strength and tone. Neurological examination revealed difficulty with motor planning as well as difficulty with basic maneuvers axial coordination, such as standing and hopping on one foot and maintaining tandem stance. The physician's evaluation revealed prominent difficulties with both fine motor and gross motor tasks. The physician concluded that the overall presentation was encephalopathy, characterized by the developmental difficulties was consistent with Asperger's syndrome. The physician considered that because early language development was not delayed, with normal acquisition of single words and brief phrases, a diagnosis of Asperger's syndrome, rather than autism was made. Because of the excessive difficulty with impulsive, hyperactive and off-task behavior he was also diagnosed with Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder. An MRI of the brain was requested to rule out a structural lesion and genetic work up.
During the shot, it felt like it entered my veins and fanned toward my heart, which was scary.   It felt like artery hardening.   Afterward my arm was sore and stiff as normal after a vaccine.  However, the stiffness  and soreness remained months later.  I felt the loss in mobility when reaching behind.  There was also pain when stretching out my arm outward.  I tried working it out to increase blood flow, however, this never seemed to go away.   I felt this during minor activities.  In November of 2021 I received a covid booster vaccination in my right arm.  In the days that followed the pain in my left arm becomes so amplified that I could not sleep at night, put on a coat or dress without severe pain.  If I reach out the pain is stifling.  It seems amplified so that even bumping my arm gives me stifling pain, reaching for objects or putting weight on my arm.
Fever, body aches, chills.  All mild. Approx 8 hrs in duration. OTC ibuprofen taken.
severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/off balance, started ~12 hours after injection
Loss of speech, eye contact and onset of repetitive movement over a 3 month period. Child evaluation center dx'd as autistic. Followup information received child also suffered gastrointestinal symptoms in April.
REDNESS AT SITE OF INJECTION.  AREA 3-4 INCHES IN DIAMETER.
Pentacel dose was given sooner than intended to the patient; the injection site quickly turned a little red; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 15 months old male patient who developed the injection site quickly turned a little red (vaccination site erythema), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 07-Jan-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number not reported) via unknown route at an unknown administration site. On 24-Mar-2020 he also received a dose of the same vaccine with an unknown batch number via unknown route at left hip area.  On 24-Mar-2020, the patient's injection site quickly turned a little red (vaccination site erythema) (non-serious), 2 months 17 days following the initial dose and on the same day following the last dose administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  The reporter stated that her physician called her after her son's visit today and informed her that Pentacel was given sooner than intended. He had a dose of Pentacel on 07-Jan-2020 and again today on 24-Mar-2020. Today's dose was given in the left hip area. The reporter reported that her son does not follow the typical schedule of vaccinations. Reporter was unsure which dose this was for her son. Today when it was given, the injection site quickly turned "a little red". The doctor told her this is common with vaccines which contain tetanus. Patient was fine otherwise. Patient had no fever.  It was also a case of actual medication error due to Drug dose administration interval too short.  No laboratory data were reported.  Final diagnosis was vaccination site erythema.   It was not reported if the patient received a corrective treatment.  Event outcome was not reported for vaccination site erythema.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
mom reports pt had t100 24 hrs p/vax; 48 hrs p/vax pts temp was nl but rt arm red, hot to touch, hard w/hive-like rash from shoulder to elow; MD spoke w/mom on phone suggest DPH; poss lymph node inflamation;
Client started feeling warm. Felt like he was going to pass out. Client became pale. Helped the patient into a lying position with legs up, gave client orange juice and blood pressure was 110/70. Client quickly regained color and felt better.
Local rash/swelling with injection site assoc with flu-like symptoms-headache, body aches, upper respiratory signs (anthrax injection site only)- occurred with initial injection 1-16-03 & reoccurred 11-16-04 & twice thereafter- lasted 3-7 days each episode- spontaneous onset & resolution and gradually decreasing in severity.
This male subject was enrolled in the prophylactic single blind study. On 20 January 2007, he received the 1st and 2nd dose of influenza vaccine (Fluarix, IM Left deltoid). On 24 January 2007, four days after the 1st dose of Fluarix, this one year old subject experienced febrile seizure. Temperature 38.3 C 2 days prior. Subject was given paracetamol for upper respiratory infection symptoms. At approximately 5pm on 24 January 2007, had 2 minutes of left staring, frozen and arching back. He was active and alert by time arrived at emergency department. He received ibuprofen. He was discharged home on 24 January 2007 at 6:35 pm. He was seen on 25 January 2007 in pediatrician office for follow up. Diagnosis was febrile seizure due to viral upper respiratory infection likely. He was alert, active. The event resolved on 24 January 2007. The investigator considered that there was a reasonable possibility that the febrile seizure may have been caused by influenza vaccine and that the event was possibly due to viral upper respiratory infection.
second injection 5/15. following day developed weakness, dizziness, myalgias, fatigue.  a few days later developed cough and drenching nightsweats and chest pressure.
Redness and swelling at injection site started 6/22/16 and got worse on 6/23/16 redness/swelling approx. 6 cm. Light headed started 6/21/16. Pain in lower back left side started 6/21/16. Pain in ribcage area in the muscles started 6/21/16. Trouble swallowing 6/21/16.
Information has been received from a physician concerning a female adolescent who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast). It was reported that during her GARDASIL vaccine (yeast) therapy, the patient experienced "significant weight loss (over 20 pounds)". The outcome of the patient was not reported. Unspecified medical attention was sought. Additional information has been requested.
Received third dose; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Received third dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Valley fever on 30-Jun-2021. Concurrent medical conditions included Hypertension since 20-Jan-2021, Hyperlipidemia since 20-Jan-2021, Obesity since 26-Apr-2021 and Thoracic aortic aneurysm (Ascending Thoracic Aortic Aneurysm) since 26-Apr-2021.   On 26-Apr-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received third dose). On 26-Apr-2021, EXTRA DOSE ADMINISTERED (Received third dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographics was added Height, weight, Race, ethnicity, Historical and current  conditions was added
"redness near the injection site has spread in diameter to to 16 cm in length and 10 cm in width which was initially bard and has now softened".; the patient starting "feeling fatigue and experiencing pain at the injection site".; the patient starting "feeling fatigue and experiencing pain at the injection site".; "fever, extreme fatigue, and redness near the injection site has spread in diameter to to 16 cm in length and 10 cm in width which was initially bard and has now softened".; "redness near the injection site was initially hard and has now softened".; "fever, extreme fatigue, and redness near the injection site has spread in diameter to to 16 cm in length and 10 cm in width which was initially bard and has now softened".; This spontaneous report as received from a consumer refers to a 34 year old female patient..   The patient's pertinent medical history included Crohn's disease. The patient did not have any drug reaction or allergy. Concomitant therapies included adalimumab (HUMIRA) and azathioprine (IMURAN (AZATHIOPRINE).  On 03-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), route of administration reported as injection, for prophylaxis (dose, lot# and expiration date were not provided).   Later that same day, the patient starting feeling fatigue and experiencing pain at the injection site. The patient also reported that every day since being vaccinated her adverse symptoms range from fever, extreme fatigue, and redness near the injection site (injection site erythema) had spread in diameter to to 16 cm in length and 10 cm in width which was initially hard (vaccination site induration) and had now softened. She contacted her physician by telephone. The patient was given treatment with diphenhydramine (BENADRYL) on an unknown date. No further symptoms were provided. At the time of reporting, the patient had not recovered from the events of fever, vaccination site pain, fatigue, injection site erythema. The outcome of vaccination site induration was recovering. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
On 2/9/21, I noticed a bump at the exact injection site. It was red, raised and about the size of a large pimple. It was itchy and warm. The next day, around 1pm, the bump had flattened and a large rash had appeared around and below the injection site. The rash is red, blotchy, itchy, tingly and warm. My skin in the area feels right. I emailed my doctor and have not heard back yet. It is currently about 9 hours after the appearance and of the rash.
Patient and her mother reported "itchy hives" down right arm that began the evening of the admission and resolved within 24 hours.  Patient took Benadryl.  (Shot was given in right deltoid).
SHE AWOKE NEXT DAY WITH PALENESS DIZZINESS SORE AND SWOLLEN ARM NECK HURT FAST HEARTRATE THROAT CLOSING WEAK.
After first dose I had tightness in chest and some heart papulations which eventually subsided after a week.  Now after my second dose I had all of the common side effects but now also am experiencing chest tightness. I honestly wish I did not get the second shot now.
about 18 hours after shot I began experiencing migraines and sensitivity to light and sounds. The migraines lasted for about 10 hours. Shortly after, about 27 hours after the shot i began experiencing a fever and body aches that are still happening as i fill out this sheet.