chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II lot # L003855, expiry date 05-FEB-2017 and lot # L026553, expiry date 16-JUL-2017 (dose, route and site of administration were not reported). There were no known side effects reported. The vaccines experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Case was vaccinated and boosted for Covid, but was then hospitalized for 21 days for Covid  in February 2022.  Hospitalized at Hospital.  * Pneumonia due to COVID-19 virus Assessment & Plan covid home test + on 1/25/22. Received sotrovimab 1/28. Admitted on 2/10/22 with respiratory failure and transferred to ICU on the 12th with high flow oxygen peaked at 60L -Suspect all due to covid, superimposed on his ILD. -Treated with 5 days of doxy completed on 2/17 to cover for potential atypical infection.  -Received tocilizumab on 2/11/22 -covid neg on the 24th so now out of isolation  -Has been on chronic prednisone taper for granulomatosis with polyangiitis, had been on 20 mg daily before admission. Reduced steroids to 40 mg pred 2/26, 30 mg on 3/2, will go back down to 20 mg on 3/5. Plan to defer to his outpatient providers for further tapering instructions. -Had rituxan induction 1/5 and 1/19.  -Down to 4L at rest. Usually on 2L NC at night only. Home oxygen prescription updated -Received IV lasix on 3/2 due to some increasing edema, much improved today, continuing his usual diuretics -Continue bactrim for PJP prophylaxis -CXR 2/28 with ILD, no longer with superimposed infiltrates -While the patient was on high flow oxygen, he was started on empiric treatment for possible venous thromboembolism. Dopplers of his legs were grossly negative, distal portion of his veins were not evaluated. It was felt that contrast exposure would be too risky so doctors decided on a 3-month course of Eliquis for possible pulmonary embolus. Low threshold to discontinue with any sort of bleeding episodes.
flared up after the first dose of pfizer covid vaccine; States it flared up after the first dose of Pfizer covid vaccine. states this is normal for her. and has nothing to do with the shot; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on 31Mar2021 at single dose for covid-19 immunisation.  Medical history included a couple of times a year pneumonia from her COPD. The patient's concomitant medications were not reported. Patient was due to have her second shot in Apr2021 however she was taking antibiotics and asked if it was ok to have the second shot of covid vaccine while taking antibiotics. Patient clarified antibiotics were for a pre-existing condition, she had COPD. Patient stated a couple of times a year she gets pneumonia from her COPD. She reported it flared up after the first dose of the vaccine. She stated this was normal for her and has nothing to do with the shot.The outcome of the event was unknown.No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The event flare up of pneumonia is unrelated to BNT162B2, the event can be attributed to an underlying COPD
Fatigue, congestion, headache, sinus pressure, pruritis/erythema/welting below injection site measuring 7.6cm x 4.5cm
Starting on 28th of march on Headache Muscle aches especially at injection site Injection site is hot Tiredness  Overall unwell feeling
A non-serious spontaneous report of we gave 14 doses of expired FLUMIST was received from a health professional concerning a 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 26-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the events is considered resolved.
Information has been received from a physician concerning a 12 month old female with eczema and food allergy and a history of influenza immunization who on 08-JUN-2007 was vaccinated with her 0.5mL SC dose of varicella virus vaccine live (Oka/Merck) (653516/0347F) in the arm. Concomitant vaccinations included a 0.5mL SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot# 652483/0148F) in the left arm. There was no illness at the time of vaccination. Prior vaccinations included a dose of influenza virus vaccine (unspecified) (December 2006). On 08-JUN-2007 the patient experienced high fever and rash within 6 hours after vaccination. Unspecified medical attention was sought. Lab diagnostic studies included a complete blood count and rash test-positive for egg. Subsequently on approximately 11-JUN-2007, the patient recovered and was sent to a pediatric allergist. In July 2007, the patient had hives and experienced vomiting after ingestion of whole egg. The patient was treated with Benadryl to resolve symptoms and pediatric epinephrine was prescribed for the egg reaction. There was no product quality complaint. Additional information is not expected.
Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to touch all over, excessive tiredness, lethargy, loss appetite.
Initial unsolicited report received from a pharmacist on 15-Nov-2017. This case involves a patient (age and gender was unknown) who was vaccinated with a dose of FLUZONE HIGH-DOSE (batch number, dose, site, route, dose in series and expiry date were not reported) on 16-Oct-2017. The medical history and concomitant medication were reported. On an unknown date, within a day or so after vaccination it became pretty painful. On an unknown date, following vaccination patient's injection site looks like a pimple and was not red or swollen but looks like if it is scratched there might be pus in it. Relevant lab tests and corrective treatment were not reported. Outcome of the events were not reported. List of documents held by sender: none.
Based on report attached on patient file, exposed to wife who is COVID-19 positive. Outpatient visit on 7/22/21 presenting with runny nose and sore throat that started 7/17/21. SARS-CoV-2 (COVID-19) RNA [Presence] in Nasopharynx with non-probe detection~SARS-CoV-2 (COVID-19) RNA [Presence] in Nasopharynx  with non-probe detection performed on 7/22/21. Came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
Extremely heavy menstruation starting with the first cycle after the 2 covid vaccines and every month since.  She also started having  large clots with her cycle.  Neither of the two symptoms (extremely heavy bleeding, and clots) did she have before the vaccine.
This spontaneous report was received from a health professional and refers to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates in 2016 (reported as "starting on or after 02-FEB-2016"), the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L013193, expiration date: 20-JAN-2017 (exact doses were not reported). There were no concomitant medications provided. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 34.4 degrees Fahrenheit for 15 hours. Additional information has been requested.
Heavy, abnormal menstrual bleeding (bleeding that was equivalent to a miscarriage every 2 weeks)  started about 4 months after the 2nd shot.  Significant testing was performed including blood work and an ultrasound that resulted in no issues.  Had to be put on birth control to stop the heavy, ongoing bleeding.
Pt reports that morning after the vaccine he got up and was shaking and chilling despite being in the shower, malaise, dry heaving, was on hands and knees without energy.  Got on the couch and stayed there for the rest of the day.
Patient complains of diarrhea, stomach cramping, and a burning in her stomach like it's "glowing".
Fatigue, fever (100), tightness in chest/rapid breathing (might have been anxiety?), headache.   While exercising: higher heart rate during significantly smaller effort; lower performance, exhaustion, and slow recovery (1 week vs 1 day).
Pt called office approx. 48 hrs after injection and reported a large bruise over L upper arm--denied any swelling, redness or increased warmth of the skin--pt was instructed to notify office if any of these sx developed. Pt was then seen at local ED three days after injection and was diagnosed with cellulitis of the arm/swelling of limb and was treated with IV Levaquin that day and returned to ED for IV Levaquin again the next day
Nearly one month of L shoulder pain which started on 11/6 after receiving influenza vaccine at clinic. Patient normally looks away during a vaccine, but recalls thinking that she didn't feel the typical upper arm muscle squeeze before the injection. (demonstrates to me bunching up of the deltoid) Afterwards noticed that the shot was more painful and she felt a little lightheaded. Over 48hrs after injection, L shoulder pain increased significantly. Couldn't raise arm to wash hair. Had trouble getting dressed/undressed. Whole lateral side of shoulder hurt at rest and with movement. Also some of anterior upper arm. Developed bruise on shoulder as well. "It seemed higher than I'm used to injections being." (indicates area a little below acromion on lateral shoulder) Has been taking naproxen consistently, but symptoms have if anything worsened over Thanksgiving break. Went winter coat shopping with mother and wasn't able to try on coats without assistance. Motions with forward elevation, internal rotation and lateral elevation are painful. Trying to avoid these motions. Using heat pad with some relief. Not sure if naproxen is helping. Do not think joint itself is involved given painless passive ROM. Appears to have painful rotator cuff c/w sprain/tendonitis immediately following an influenza vaccination. Gave handout on rotator cuff injury from Patient Sports Medicine Advisor. Referral to PT for improvement in function and symptoms.
pt states that later the same day she started running 100.5 fever, had body aches, sore right arm.   Next Morning she took 2 ibuprofen.  A couple of hours later her fever was down to 99.  She still had body aches and sore arm.  Later that day she was still hurting and took 2 Tylenol.  On 3/17 she woke up sweating but her body aches were better and temp was back down to 97.  Pt developed a large 3 1/2 x 4 red, burning, itchy rash on upper right arm.  On 3/19 Pt seems to think the rash is a little less red and itchy today but her arm is still sore.
Patient received MMR, DTaP, and IPV (had previously received all of these shots as infant/toddler without reaction) and within five minutes of administration developed throat tightness, shortness of breath, and sudden conjunctival injection.  Patient required a nebulized albuterol treatment, sub-cutaneous epinephrine, and oral dose of benadryl.  Patient was seen in Hospital emergency room, was given an IV dose of Solumedrol and observed for 4-6 hours
targeted head pain (not a generalized headache); Fever; chills; muscle and joint pain; muscle and joint pain and soreness; nausea; thirst; tiredness; injection site soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 37-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Feb2021 at 15:15 pm (age at vaccination was 37 years) as dose 2, single for COVID-19 immunization. The patient's medical history included asthma, migraines, sinus infections, carpal tunnel and allergy (OTC allergy meds). Concomitant medications the patient received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), montelukast sodium (SINGULAIR) calcium, magnesium, OTC allergy meds and daily multivitamin all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 29Jan2021 at 15:30 pm (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Feb2021 at 04:30 am, the patient experienced fever, chills, muscle and joint pain and soreness, targeted head pain (not a generalized headache), nausea, thirst, tiredness, injection site soreness. No treatment was received for the adverse events. The outcome of the events was not resolved.   Follow-up attempts completed. No further information expected.
Patient was schedule to receive 1st dose of Pfizer but instead receive Moderna Booster vaccine dose
Pt was given injection on 09/13/13 - developed redness swelling Rt deltoid on 9/14/13. In the shape of a "Z" about 4 cm long. Treated with LEVAQUIN 500 mg dly x 7 days.
R arm from the upper arm to hand could not bend it; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (R arm from the upper arm to hand could not bend it) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was reported.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced LIMB DISCOMFORT (R arm from the upper arm to hand could not bend it). On 12-Mar-2021, LIMB DISCOMFORT (R arm from the upper arm to hand could not bend it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Chills and fever up to 102.5 reduced with advil. Fever started about 24 hours after vaccine was administered.  Gone around 48 hours after.  Swelling and redness at injection site. No stealing.
Two days after third dose, employee developed rash on arms, third day employee woke up with swollen red face, blurred vision.
This spontaneous report was received from an office manager and refers to multiple unspecified patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route and site of administration were not reported), lot #M008551 (expiration date 02-JUN-2018), lot # L048236 (expiration date 31-MAR-2018), lot # M010671 (expiration date 02-JUN-2018) or lot # M020926 (expiration date 11-AUG-2018). The administered doses of vaccine were exposed to the temperature of 30 degrees Fahrenheit for 11 hours. No adverse effects were reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
a few minutes after recieving the vaccine i got dizzy, cold sweats, tingly feeling all over body, and broke out in a red slightly itchy rash.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2022-566260, MOD-2022-566266 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up appended, contains no new information.
This 45 year old  black female received the Covid shot on  12/28/20    and went to the ED on  1/7/21     and was admitted  on /21 with the following diagnoses listed below. COVID-19
08/29/21 Pain site of injection could not lift arm above shoulder 2 days 09/01/21 Rash on neck and chest Applied cortizone creme subsized itchiness 09/03/21 Severe headache lasted 2 days  Took advil did not help, next day took BC powder helped for few hours but came back 09/05/21 2 bruises ( dime size) back of arm Notice distance vision  blurry while driving 09/06/21 2 bruises on front of arm Bruises on back of arm disappeared
NO ADVERSE EVENT BUT PATIENT RECIEVED THE VACCINE PASS RECOMENDED EXPIRATION DATE BY THE MANUFACTURE.
This spontaneous report was received from a pharmacist referring to a 61 year old female patient. Information regarding the patient's concurrent conditions included allergies to penicillin, sulfonamides and codeine.  On 08-APR-2016, the patient was vaccinated with ZOSTAVAX 0.65ml, subcutaneously, lot # L040442 with expiration date of 15-JAN-2017 (dose number was not provided). The patient's concomitant therapies included MAXZIDE. Approximately in 2016, reported as on unspecified time after receiving ZOSTAVAX, the patient developed a "systemic fatigue" (fatigue), muscle pain (myalgia) and redness at the injection site (injection site erythema). The pharmacist stated, that the patient was seen on 28-APR-2016 and she reported the adverse reaction, however no treatment was given for it. Moreover, no laboratory diagnostic studies were performed. It was reported by the pharmacist that on 09-JUN-2016, the patient came back to the pharmacy and stated that the fatigue was present but, the redness was getting better. Furthermore, no product quality issue was involved. The outcome of myalgia was unknown. The relatedness between the adverse events and vaccination with ZOSTAVAX was not reported. Additional information is not expected as consent to contact the physician was not provided.
I received my booster shot at a local pharmacy and the following day developed a very painful and sore arm but with o other symptoms.  On the second day after receiving the vaccination, I developed a sudden sharp catching  or impingement in my shoulder that crippled my arm when reaching for a cell phone.  The pain was sudden and onset acute.  It affected my shoulder so that my arm could not be used for any purpose such as lifting, moving, pushing, pulling, or doing any thing other than holding it tight against my body.  This was followed by a constant aching in my shoulder even when no range of motion was used.  I started taking celebrex and icing my shoulder.  The pain and limited range of motion continued for the next 24 hours, until I received some relief the next day so that I had minimal ROM.  The shoulder catching or impingement continued when lifting the arm to the side, in front of me or lifting my arm.  I saw a doctor at an urgent care on the 4th day after the injection and was diagnosed with an adverse effect to the possible administration of the vaccine or reaction to the vaccine itself in my arm.  I was  referred to Physical Therapy and continued to take celebrex.  I have been to one session of PT and on day 5 after receiving the vaccine starting to return to more normal .
Lethargic,  then fainted . Also had a rash that was hot to the touch around the vaccine site
Muscle and joint pain LUE with limitation of LUE ROM.   Problem still persists.  It waxes and wanes with intensity, but never goes completely away.
More than 42 days have passed since first dose, still didn't get second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed since first dose, still didn't get second dose) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed since first dose, still didn't get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed since first dose, still didn't get second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 23 May 2021 does not contain any new information. On 14-May-2021: Follow up received on 30 May 2021 does not contain any new information.
Patient has small rash that displayed after the first dose of Moderna.   4/8/21. The second dose of Moderna was administered on 5/7/21. Patient broke out under left armpit  and  chest area. Patient seen in office on 5/14/2021. Patient given Prednisone 20mg   BID  x 5 days and Hydroxyzine 10mg and Triamoncinolme 0.5%  ointment. On 5/17/2021 patient returned with rash that has spread across chest. Kenalog  80 mg given in Right Buttock.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED DEVICE USED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED DEVICE USED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED DEVICE USED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 63 years and 9 months. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Patient received third dose of vaccine. Moderna vaccine Ndc code reported. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   No treatment medication information was provided.