chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cough; runny nose; sore throat; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and COUGH (cough) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat). On 21-Jan-2021, the patient experienced COUGH (cough). At the time of the report, RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and COUGH (cough) 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.
Information has been received from a physician concerning a female with a history of dental procedure in which paralysis occurred who was vaccinated with GARDASIL IM.  The patient developed paralysis after vaccination.  The patient was considered to be disabling.  The patient sought medical attention.  Additional information has been requested.
Nausea; Headache; Stiff arm and neck; Almost fainting; Dizziness; Cold achy; Cold achy; Tired; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration on 30Mar2021 at 11:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included one kidney, lost left kidney to cancer, mitral valve prolapse, and left ventricle blockage in heart. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included ibuprofen (ADVIL) from an unknown date for an unknown indication. The patient previously received tetracycline from an unknown date and experienced allergy. The patient previously received dose 1 of BNT162B2 (lot number EN6204) on 19Mar2021 at 12:00 as a single dose in the right arm for COVID-19 immunization and experienced arm and neck pain instantly, fever, chills, and nausea. After the second dose of BNT162B2 on day 1 (30Mar2021) the patient experienced tired. On day 2 (31Mar2021) the patient was cold and achy. On day 3 (01Apr2021) the patient experienced stiff arm and neck. On day 4 (02Apr2021) the patient experienced nausea and headache. Two weeks later the patient had dizziness, almost fainting, and continued dizziness. The events were reported as non-serious. The patient was not hospitalized for the events. It was unknown if the patient received any treatment for the events. The outcomes of tired, cold, achy, stiff arm and neck, nausea, headache, dizziness, and almost fainting were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021403996 same patient, different drug(dose)/events
This spontaneous report was received from a healthcare worker via company representative refers to a male patient of unknown age. No pertinent medical history was reported. On 09-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route, lot# were not reported). Concomitant medications were not reported. On 10-OCT-2014, the patient experienced herpes zoster within 24 hours of the vaccination. Patient sought medical attention by an office contact. No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. Causality was not provided by the reporter. Additional information has been requested.
Shoulder is sore/Shoulder with the rotator cuff tear is sore right now; rotatorcuff tear is aggravated due to something he did.; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Shoulder is sore/Shoulder with the rotator cuff tear is sore right now) and CONDITION AGGRAVATED (rotatorcuff tear is aggravated due to something he did.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient did not had positive covid test or diagnosis.  The patient's past medical history included Shoulder arthroplasty (The patient stated that he has artificial shoulder since 2016 and a rotator cuff partial tear shoulder since 2017 and stated that both were before he received the 1st dose of Moderna vaccine) in 2016. Concurrent medical conditions included Drug intolerance (Percocet and Ibuprofen) and Lactose intolerant. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for an unknown indication.   On 22-Oct-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder is sore/Shoulder with the rotator cuff tear is sore right now) and CONDITION AGGRAVATED (rotatorcuff tear is aggravated due to something he did.). At the time of the report, ARTHRALGIA (Shoulder is sore/Shoulder with the rotator cuff tear is sore right now) and CONDITION AGGRAVATED (rotatorcuff tear is aggravated due to something he did.) outcome was unknown.            The patient reported that all 3 doses so far were administered in recommended time frame but was unable to provide dates for the first 2 doses and lot numbers and expiration dates.  The patient reported that all the shots were intramuscular injections into the left shoulder that is the non-artificial one with a tear in it.  No treatment medication details reported.
Pt. arrived for dose #2 04/26/2021.  We refused and informed that dose #2 can be given after 16th birthday.
It was reported in a published article concerning a 3 year old male pt with no evidence of immunodeficiency who was vaccinated at 2, 4, 6 and 18 months of age with Hib conj vaccine. Subsequently, the pt presented with a 1-day history of fever and rigors. The temp was 39.2 deg C, and the leukocyte count was 8000 per mm3 with 88% neutrophils. He was discharged without antibiotic therapy. It was noted that the pt was "recalled" and hospitalized the next day because a blood culture yielded Gram-negative rods subsequently identified as Hib resistant to ampicillin and susceptible to ceftriaxone. A second blood culture performed on the day of admission was sterile. Examination of the cerebral spinal fluid, including latex agglutination for Hib capsular polysaccharide antigen (obtained after 2 doses of ceftriaxone) was normal. Immunologic studies revealed normal total serum immunoglobulins, subclasses and total hemolytic complement. The concentration of serum antibody to the sterotype b H influenzae capsule obtained during the second day of the hospitalization was 0.45 ug/mL by enzyme-linked immunosorbent assay and two months later, the level was 2.0 ug/mL. The serum anti-hep B surface antibody was "in the protective range." The child had detectable anticapsular antibody in his serum 3 days after the onset of bacteremia. The pt received 3 days of ceftriazone and was discharged to complete 7 days of cefpodoxime. It was noted that the child lived at home with his parents and did not attend day care. It was also noted that the child was probably exposed to Hib in pharyngeal secretions from close contact and developed bacteremia despite being immunized. No further info was provided.
This case was reported by a consumer via call center representative and described the occurrence of tingling in a 53-year-old male patient who received SHINGRIX. Concomitant products included Furosemide and Lisinopril. On 9th May 2018 10:00, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, 8 hrs after receiving SHINGRIX, the patient experienced tingling, general body pain and malaise. On an unknown date, the outcome of the tingling, general body pain and malaise. On an unknown date, the outcome of the tingling, general pain and malaise were recovering/resolving. The reporter considered the tingling, general body pain and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: Eight hours after receiving the vaccination, the patient had tingling on his right side in his thigh, chin, orbit of his eye, his ankle and a finger (all on the right side). Less than a day after receiving vaccination, the patient also was sore and achy all over and had slight malaise. The patient had denied permission to contact their physician. The vaccination was done by the pharmacist so patient did not see the need for his doctor to be contacted.
Information has been received from a physician concerning a 23 weeks old patient who on 19-FEB-2009 was vaccinated orally with the first 2 ml dose of ROTATEQ (lot # 661053/1264X).  The physician reported that the patient was late starting the ROTATEQ series.  No adverse effects were reported.  The patient was seen at the office and sought unspecified medical attention.  Additional information has been requested.
chest pain, multiple subsegmental pulmonary emboli without acute cor pulmonale; anemia, massive GI bleed, tachycardia, lightheadedness, midepigastric abdominal pain, bilateral adrenal masses.
Patient was seen at Clinic on 2/4/2020 and was due for the following vaccines: Pneumovax 23, Flu and Tetanus. Patient had multiple layers of clothing on and declined to remove any in order for me to reach the deltoid. Patient pulled his layers of clothing as far up as he could. I then administered Pneumovax 23 and Flu on right upper arm and Tetanus on left upper arm. Patient waited 15 minutes after vaccines were administered and showed no signs or symptoms. Patient then came to the clinic again on 2/7/2020 and stated on 2/4/2020 evening he started with body chills, sweats, fever and localized redness and pain on right upper arm, just underneath the deltoid. Patient was treated for allergic reaction and cellulitis with oral Keflex and Rocephin as injection. Patient is doing good now.
Patient came to pharmacy on 10/3/18 complaining that her arm still hurts from her influenza vaccine she had received on 9/8/18. She states her pain and swelling commenced about 1&1/2 weeks after receiving the vaccine. She says she still has pain and swelling that has since radiated to her elbow. She is having a difficult time lifting her arm and extending her elbow.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
The injection was painful and the injection site remained painful for a few days. It was more painful than in past years, but I brushed it off as normal reaction anyway, especially as the contact pain, redness, and swelling went away. However, since then, I have been left with shoulder pain. It is a burning pain and deep strain in what feels like the muscle where the shot was administered. It is constant, somewhat limits my range of motion (backward), bothers me when lifting heavy objects, and also wakes me up at night to the point that I have to sit up and try to rub and stretch my arm in different ways.
more then one mentral cycle a month, and now no mentral cycle 40 days and counting.  increase in stomach bile, constant fatique
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients received an unspecified number of improperly stored doses of VARIVAX (subcutaneous, dose and lot number not provided) on unspecified dates since 25-JAN-2015. No adverse effect reported. Additional information has been requested.
Fever; Rigours; Myalgia; Headache; site redness; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: not provided), via an unspecified route of administration in her left arm on 11Jan2021 at 12:00AM (at the age of 54-years-old), for covid-19 dose1 immunisation. The patients medical history included abnormal cholesterol and COVID-19 dose 1 vaccination. Past drug history was not reported. Concomitant medications were not reported. The patient has reported no allergies to medications, food or other products. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has received other medications within 2 weeks of vaccination The patient has not tested positive for COVID-19 since having the vaccine. The patient has not diagnosed with COVID-19 prior to vaccination. On 12Jan2021, the subject experienced fever, rigors, myalgia, headache, vaccination site redness post 12 hours of vaccination, the subject was treated with acetaminophen (Trade Name: Tylenol). The clinical outcome of the events fever, rigors, myalgia, headache, vaccination site redness was resolved. No follow-up attempts are needed. No further information is expected.
Bad cramps in my arm and my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 17Apr2021, outcome "unknown", described as "Bad cramps in my arm and my hand". Therapeutic measures were taken as a result of muscle spasms.  Additional Information: The events started about three and 4 hours after the vaccination. The patient took three paracetamol (TYLENOL) as treatment and wanted to know what to do about that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Syncope or seizure 10 hours after vaccine, preceded about about 1 hour of aches, chills, and feverish feeling. Resulted in fall to floor,  hitting head and injuring shoulder. EMTs reported hypertension, tachycardia, trembling, some EKG abnormality, and low-grade fever. Transported to emergency room where CT scan, CBC, and additional labs and monitoring were performed. Released when scans and labs were normal (after monitoring.)
Pt developed severe narcolepsy with cataplexy within one month of H1N1 vaccine. Pt. is HLADQB1*0602 (+). Treatment includes: XYREM, Imipramine, RITALIN.
Redness in hands, arms-itching in throat-  light rash on arms and chest and back
Right side of face numb. Per ER Bell?s palsy. Currently on steroids for inflammatiin and antiviral medication and eye antibiotic ointment.
Patient had pain and some swelling at injection site and could not lift arm up all the way without pain-Discontinue of arm movement has continued for 3 weeks and has very slowly been improving.
Fluid accumulation in right foot localized above ankle as in a ?pocket? or pronounced lump? No pain but wish to report just in case it is or was significant in others, incl those who may have received trial vaccine(s) in years past.
All over body hives within 48 hours of injection requiring prednisone treatment. Began 6 day prednisone course 4/16/21 a.m. Outcome unknown.
At work, throughout her day she started urinating more frequently; she wasn't feeling 100%, fatigue, tiredness, kidneys started hurting on both sides.  That continued on all night long, every 30 minutes;  Her kidneys started aching.  That all continued the whole day.  She got a covid arm rash the following day.   By day 3, she started urinating normally.  The right kidney pain diminished.  The left kidney pain has continued and is intermittent.  It does let up and go away.  But comes back occasionally.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves an 88 years old female patient who received a 0.5 mL dose of FLUZONE HIGH DOSE lot UI977AB, expiry date: 09-Mar-2019, via intramuscular route in the left deltoid and then again a 0.5 mL dose of it lot UJ006AB, expiry date:14-Apr-2019, via intramuscular route in the left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was reported that patient was accidentally administered FLUZONE HIGH DOSE on 13-Aug-2018 and then again on 12-Sep-2018 due to a clerical error. The previous immunization was not documented so they reinjected the FLUZONE HIGH DOSE. The patient did not experience any adverse event following the vaccination. 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. List of documents held by the sender: none.
29 YO WV M 20D POST-VAX RASH ON CHEEKBONE; QUESTION FROM STATE AE COORDINATOR ABOUT STEROID TREATMENT; HISTORY OF POISON IVY ON HANDS 1-2 DAYS PRIOR TO CHEEKBONE RASH ONSET; WORKING DX: NON-SPECIFIC RASH, MOST LIKELY CONTACT DERMATITIS
arm is really numb; arm is painful; it is now cramping up; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date are Not Provided), via an unspecified route of administration on 29Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. It was reported that she got the Pfizer shot on the 29th, and on an unspecified date in Mar2021, her arm was numb, it was really painful, she has taken Ibuprofen and done everything, she was ready to do something that call handler was not able to clarify, and fight, and on an unspecified date in Mar2021, it was now cramping up, so she was seeking recommendations. Speakerphone recording notification given and caller says she was at the clinic there are people there, then says hold on and abruptly disconnects the call. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial shot:  nausea, extreme fatigue for 5 days.  Second shot:  immediate arm pain, warm.  In the first day lightheaded,  limbs heavy feeling, unfocused, flushed, fatigue,  hives for about an hour.  Next day headache, lightheaded,  neck tightness, fatigue,  lymph node pain, arm pain, nausea.  Next day nausea,  arm pain, stomach pain, fatigue.   Next day nausea  and fatigue.   Nausea lasted 5 days.
pt recvd vax; 15 days later, devel lesions on her chest; subsequently devel HA & stiff neck; at time of rpt had many lesions all over body;
Rash at site of injection 11 days later.  There was swelling and pain within 24 hrs of vaccine but it went away and then this just appeared today.
Headache on top left of head at 1900; getting it everyday since. It comes and goes. Pain level around  a 4/10. No history of HA. Seems to be improving a small bit as of 5/01/2021.    Legs feel weak. Like I have done an extreme workout. That started  4/10/2021 at 2100 PM.  My legs still feel very weak. Some slight improvement  as of 5/01/2021.
URI- Treatment Accuhist. Lump on right deltoid -  no treatment was given. Mom described that it was red and swollen after vaccination was given on 11-26-2007.