chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; hurt to move it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HYPOKINESIA (hurt to move it) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HYPOKINESIA (hurt to move it). At the time of the report, PAIN IN EXTREMITY (sore arm) and HYPOKINESIA (hurt to move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: No new information reported. No consent for further follow-up.
pt recv vax 14JUL97 &  devel 2 to 4 inch area of redness, swelling, & hardness @ inj site & pain & soreness @ inj site;following day pt exp a mild h/a;17JUL97 devel mild aches, chills & tiredness;pt recv 2 doses of pneumovax rather than one
Vaccine site burning first about 10 minutes form vaccination, then body aches; feeling slightly better today Narrative:
Chills , chest pain , pain on joints , urinary frecuency , pain on testicles
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning an eight-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 06-Dec-2010. On 20-Dec-2010, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 04-Mar-2011 and incorporated into case: no late occurring adverse events.
Subsequent to receiving vax, the pt experienced rash and itching at the injection site. Engerix B was discontinued. The most recent information received reports the condition of the pt is unknown.
Accidentally given / had expired a couple of days before; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. A Menveo vaccine was accidentally given to one of the patients that had expired a couple days before hand. The reporter was wondering if they had to re vaccinate to the patient. The reporter consented to follow up.
Headache, NauseaVomiting, Migraine, eye twitching, hot flashes Narrative:
I started positive for COVID-19 on 22NOV2022, I was having a fever, body aches and a cough or sore throat. I did get a PAXLOVID prescription from the local state website. I started feeling better within 3 hours of taking the medication.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Valacyclovir unknown for shingles. The patient's past medical history included shingles (experienced 8 times and most recently in December 2017, January 2018 and February 2018). Previously administered products included ZOSTAVAX (received many years prior to the date of reporting). On 31st August 2018, the patient received SHINGRIX (intramuscular). On an unknown date, the patient started Valacyclovir 500 mg once daily (500 mg daily). On 5th September 2018, 5 days after receiving SHINGRIX and less than a year after starting Valacyclovir, the patient experienced red blotches. On 6th September 2018, the patient experienced pain, swelling, burning sensation, vesicular rash, fever blister and erythema. On an unknown date, the patient experienced muscle pain. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the pain, swelling, burning sensation, vesicular rash, fever blister and erythema were not recovered/not resolved and the outcome of the red blotches was recovering/resolving. It was unknown if the reporter considered the muscle pain, pain, swelling, burning sensation, red blotches, vesicular rash, fever blister and erythema to be related to SHINGRIX and Valacyclovir. Additional information was reported as follows: In early 2018, the patient had experienced shingles 3 times within 6 weeks, for which she had been taking Valacyclovir. After the previous cases of Shingles were resolved the patient took Valacyclovir 500 mg twice daily, but after vaccination with SHINGRIX, the patient was instructed to take 500 mg daily. The patient experienced bad muscle pain after receiving SHINGRIX, which was resolved after 2 days. On the fifth day, the patient noticed three big red blotches which went down her arm from the injection site. On the sixth day, the patient saw a spot which looked like a spot of Shingles on her neck underneath her ear and was red and swollen. A day before the date of reporting, it felt like the patient got a fever blister between her lip and chin where the fever blister was burning, painful. The blotches were fading at the time of report.
This spontaneous report as received from a pharmacist via field employee refers approximately 60 year old male (reported as in his sixties) immunocompromised patient. Patient medical history and other current condition was not reported. Approximately in NOVEMBER-2014 (reported as in the month of November) the patient was vaccinated with ZOSTAVAX Vial for prevention of shingles. Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced rash. It was reported that the patient sought treatment (no details were provided) reported as seen in the office. Cancer and overdose was not reported. Product quality complaint was not reported. The outcome of rash was reported as recovering/resolving. Causality assessment was not provided by the reporter. Additional information has been requested.
Information has been received from a consumer concerning her 19 year old daughter who in December 2008 finished her three doses series of GARDASIL. On approximately 31-JUL-2009 "three weeks ago", the patient developed throat infection and went to her physician's office on 17-AUG-2007. While in the office visit the patient was administered with a fourth dose of GARDASIL. The patient's final outcome was not reported. No further information is available.
Swollen lymph node under left deltoid. Severe pain in chest, back, elbow, underarm. Day number 5 and counting.
I developed unusual vaginal bleeding in April 2021.  In December 2021 I was diagnosed with Endometrial Adenocarcinoma.  I had a total hysterectomy on January 6, 2022 at Medical Center and am having 3 radiation treatments now (March 2022).  I appear to be cancer free at this time.   I don't think this is related to the COVID vaccine and none of my healthcare providers mentioned this either.
This spontaneous report has been received from a pharmacist concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified dates, the patients were administered separate doses of improperly stored ZOSTAVAX lot # M035692, expiration date 07-NOV-2017 (dose, frequency, route of administration were not reported). There were two temperature excursions 15°F to 46°F , both with a time frame of 14 hours. No adverse effects were reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 60 year old white female secretary (weight 260) who on 20-APR-2007 was vaccinated with a dose of Zostavax. SQ in the left arm. Concomitant therapy included Coumadin. On 20-APR-2007 Coumadin was held for one day. On 24-APR-2007 the patient had an elevated INR of 1.5 and prothrombin time (PT) was 41.5 sec.  On 01-MAY-2007 the patient's INR was rechecked and found to be elevated at 3.9 and PT was 46.2 sec.  Therapy with Coumadin was held for one day and decreased to 2.5mg/week.  On 08-MAY-2007, INR was 3.0 ans PT was 15.4 sec. the patient's regular dosing of Coumadin was resumed.  On 22-MAY-2007, INR was 4.6 and PT was 55.4 sec. therapy with Coumadin was held for two days and the dose was decreased to 2.5mg/week.  On 29-MAY-2007. INR was 1.5 and PT was 23.2 the patient resumed dosing of Coumadin.  Unspecified medical attention was sought. There was no product quality complaint involved. At the time of reporting, the outcome of the event was not reported. Additional information is not expected.  Additional information has been requested.  This is one of several reports from the same source.
On March 11, 2021, the top of my left shoulder painful down my arm, across my shoulder to the back of my entire neck was very painful. I went to the Emergency room on 03/12/2021, the Chiropractor on 12/13/2021, and then I saw a PA after that. There really wasn't much they could do and the ER Provider gave me muscle relaxers. The Chiropractor recommended stretches and massage and that really helped but it took over a month to resolved. They didn't really request any tests. I was diagnosed with a specific name for the inflammation of my neck but I cannot recall.
This spontaneous report as received from a health professional refers to a 15 month old patient. On 01-MAY-2014 the patient was vaccinated with VARIVAX (lot # J009164, EXP 24-JUL-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a physician concerning a 13 year old female who on unspecified dates was vaccinated with the first and second dose of GARDASIL. After receiving the first dose her arm was numb for a couple of hours, and after receiving her second dose her arm was even more numb. The patient sought unspecified medical attention. At the time of the reporting, the patient had recovered. Additional information has been requested.
Information has been received from a health professional concerning a 4 year old female who on 30-May-2000 was vaccinated with a dose of varicella virus vaccine live. On 17-Mar-2003 the patient developed break-through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break-through chickenpox (WAES #0305USA00356, 0304USA00584, 0305USA00586 through 0305USA00595). Additional information has been requested.
Arrived with c/o palpitations & dizziness, found to be COVID+. Completed vaccine 2/2021. Reported runny nose and dry cough x1 week PTA. Progressed to Bipap. Steroids, O2, remdesivir, zinc, updratfts. Weaned to 1-2L NC. Discharged home with O2.
pt recv vax 6OCT95 & devel a tennis ball size swelling @ inj site which resolved p/several days;addtl info recv 7DEC95: pt devel $1.00 sized red welt following vax;
From March 27, 2019 through April 25, 2019 I experienced six burning/rash outbreaks and diarrhea. Midafternoon on march 27th I began to feel fatigued. That night the diarrhea began which lasted for six days. The next morning I experienced my first outbreak. Each outbreak was three days of intense 'burning' with bright red skin and then it would begin to temper with the color gradually fading through shades of pink to white along with an itchy rash. Each outbreak lasted 7-8 days. The outbreaks overlapped and so I experienced all these effects continually  for four weeks. the day following the three days of bright red burning, the skin was still hot but calmer (day 4) , and then the next day (day 5) another system would experience an outbreak. As the itching subsided the skin became very dry and flakey. The outbreaks in order: legs, arms, groin, midriff & lower back, left side and buttock, nner and upper thigh of both legs.
Hospitalization: 1/26/2023 - 1/29/2023 (3 days) Presentation to the ED: shortness of breath and hypoxemia.  COVID + date: 1/26/2023 Treatment: remdesivir and steroids and o2 supplementation. Discharge to: home.  044A21A 3/10/2021 046B21A 4/12/2021 032H21A 12/13/2021
Patient reported red welt warm to touch on back of arm where zoster vaccine was administered. She was instructed to ice the area and take ibuprofen to help with redness and swelling; told patient if worsened or did not improve within next day or two to see healthcare provider. Patient came to pharmacy on 6/28/16 and showed her arm. Back of arm where vaccine was administered was still very red and warm to the touch and had spread down to the forearm. Instructed patient to see her healthcare professional.
facial pain and increased swelling that began 24 hours post injection and increased in severity leading to an ER visit; facial pain and increased swelling that began 24 hours post injection and increased in severity leading to an ER visit; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number was not reported) via an unspecified route of administration, administered in right arm on 27Feb2021 (at the age of 66-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number was not reported), via an unspecified route of administration, administered in right arm on 06Feb2021 as single dose for COVID-19 immunisation. The patient had no known allergies and did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccine. Prior the vaccination, the patient was not diagnosed with COVID-19. On 28Feb2021 (next day of vaccination), patient experienced facial pain and increased swelling that began 24 hours post injection and increased in severity as a result of which, patient had an emergency room/department or urgent care visit. Since the vaccination the patient was not tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from an office manager concerning a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date in April 2017, the adult patient was vaccinated with a pediatric dose of RECOMBIVAX HB (drug administered to patient of inappropriate age) (dosing details, lot#, expiry date and route were not provided) for prophylaxis. Therapy with RECOMBIVAX HB was not discontinued. No adverse effect reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of ROTATEQ (oral by default, dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014065, 1507USA014067, 1507USA014068 and 1507USA013244). Additional information has been requested.
Patient is a 52 y.o. male known history of cirrhosis of liver with ascites, acute on chronic anemia, hypertension, left knee TKR 6 who presented from home on 9/19/2023 with left knee pain and shortness of breath and found left prosthetic knee infection complicated by sepsis due to prosthetic joint infection as well as streptococcal bacteremia and COVID-19.  Patient was followed by hepatologist for decompensated cirrhosis of liver with ascites required 3 times abdominal paracentesis and also found SBP.  Patient followed by infectious disease specialist for prosthetic joint infection with streptococcal bacteremia and given IV Rocephin and continue for 6 weeks.  Hepatologist recommended to restart oral Cipro once completed IV Rocephin as outpatient for SBP.  Patient needs follow-up ID, hepatologist as outpatient.    Left Prosthetic Knee infection Sepsis due to prosthetic joint infection and bacteremia and COVID-19 present on admission: -ID and ortho following. S/p arthrodesis 9/20. Fluid c/w infection with more than 50,000 WBC, culture negative patient had 1 set of blood culture with strep mutans on admission -S/p I&D with TKA explant and antibiotic spacer placement 9/22 with Dr. -Continue IV antibiotics per ID on Rocephin. Surgical cultures with no growth. ID now signed off with PICC line placed for IV Rocephin 2 g every 24 hours for total of 6 weeks with stop date 11/3/2023 and maintain IV until ID follow-up with weekly CBC with differential, CMP, ESR, CRP faxed and follow-up ID CNP on 11/2/2023 at 12 PM   Streptococcal bacteremia   -1/2 blood cultures growing strep viridans. -Secondary to prosthetic joint infection -ID as above rocephin IV for 6 weeks.  Repeat blood cx 9/22 NGTD  Covid-19 infection   -He was found to be positive on admission -Evaluated by ID.  Patient was given on Remdesivir for 5 days and completed.  -Patient was given IV decadron X 5 DAYS and will discontinue due to leukocytosis.  -has been vaccinated but has not received booster -Continue isolation at present for total of 10 days   Decompensated cirrhosis with ascites   -Known cirrhosis with ascites s/p paracentesis last week. Noted to have reaccumulation on exam and imaging -Repeat paracentesis done 9/21 with removal of 7L fluid. Cultures not sent and fluid no longer available -Hepatology consulted. He will need repeat EGD in 4 weeks. Resume cipro SBP prophylaxis once he completes antibiotics for current infection -Hepatologist increased bumex to bid as well as spironolactone increased to twice daily on 9/25.. Cont thiamine and folate.  -Repeat US with moderate to large ascites and repeat paracentesis completed with 2.1 L fluid removed and finding consistent with SBP with ascitic fluid study including cell count  -Hepatologist recommending repeat another paracentesis on 9/27  -Received IV albumin.  -Continue increase diuretic regimen per hepatologist, follow-up liver clinic already scheduled.  -Avoid narcotics as well as benzodiazepine -Can use Tylenol up to 2 g/day for pain.  -Follow-up hepatology clinic   Acute on chronic anemia   -acute on chronic -relatively stable compared to baseline. Cont to monitor post op   Hypertension  -Continue on increased coreg dose for now
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose a GARDASIL. Suspect vaccinations administered on that day included a dose of DTAP and MENACTRA. Subsequently the patient experienced syncope. It was unknown whether medical attention was sought. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Within a few weeks after receiving first COVID injection patient became experiencing memory issues.    Workup has led to showing a temporal lobe stroke. Her symptoms include difficulty with memory. Impaired speech, knowing what she wants to say but words coming out wrong. Mild emotional issues. Mild aggression. Physically intact.
Normal, expected fatigue the next day, but nothing I couldn't work through.  The following day, Sudden onset of dizziness and nausea.  Upon sitting down, sudden onset of extreme chills, to the point of shaking so terribly that my muscles hurt.  I sat with 4 or 5 blankets on me and tried to rest until the shaking subsided.  I asked a family member to sit and monitor me, as I was unable to do anything due to the shaking.  This lasted approximately 2.5 hours, then stopped, leaving my muscles feeling sore and overworked. It was exhausting.
Erythema, fluctuance, what appears to be sterile abscess formation with associated fever to 102 persistently, treated with Bactrim.
Presented to emergency department on 4/30/21  with blurred vision and dizziness. Patient was admitted for further evaluation of possible stroke and was found to be COVID-19 positive during admission screening. She has had minimal symptoms at time of reporting that have not required treatment. Patient is still admitted at time of writing.
Patient reports "it hurt really bad" immediately following shot and soreness in entire arm for 1 week following.  No redness, rash, or fever, but patient does report a knot at injection site.  Patient declined coming back to the pharmacy for examination.
Still tired; Felt some muscle ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Still tired) and MYALGIA (Felt some muscle ache) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Still tired) and MYALGIA (Felt some muscle ache). At the time of the report, FATIGUE (Still tired) and MYALGIA (Felt some muscle ache) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
I had a residual cough when I had the vaccine. Up to a week after vaccine, I had low grade fever and chills; night sweating and coughing seemed to be getting worse and coughing getting more frequent and worse (when it had been dry and occasional). It was ongoing for a week. I called my Doctor during that time and she prescribed me medications including an antibiotic and cold medications for the cough. The medications helped symptoms after I'd been on them awhile . I no longer have the fever and I stopped the night sweating. Cough seems to be improved.
Patient administered First Dose Covid Vaccine. 10 minutes into observation period, patient states she is having shortness of breath, increased heart rate, tongue numbness, and lip and mouth numbness. RPH Administered 25mg of liquid bendaryl to patient and called 911 for EMS/Paramedics. Patient was taken on stretcher to ER with father.  Patient was alert and able to respond/talk to staff/paramedics at time of departure
approx 45-60 min p/vax throat started to feel tight;pt waited to say anything thinking it would get better;1 of MD looked @ neck & throat & listened to voice & sent to ER;med given. A 31-year-old female was vaccinated with FLU-FLUZONE given '96-'97 (type not specified) on 31-Oct-1996. One hour after the dose it was reported that she developed difficulty breathing, red eyes, swelling of the face, neck and throat and anaphylaxis. There was no history of egg allery or any allergies reported. She is now off PREDNISONE as of today (5-Dec-1996) and her throat has remained swollen until today (5-Dec-1996). The patients local physician feels her vocal chords have been effected. From follow-up information on 29-July-1999, additional patient and vaccine information was provided.