chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; Fatigue; Muscle ache; generalized weakness; unable to stand for minimal amount of time due to chills and generalized weakness; This is a spontaneous report from a contactable Nurse, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration on 27Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included AFib, rheumatoid arthritis (RA), migraine, asthma, congestive heart failure (CHF), prosthetic heart valve, allergies, hyperlipidemia and pacemaker. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), digoxin (MANUFACTURER UNKNOWN), verapamil (MANUFACTURER UNKNOWN), abatacept (ORENCIA), prednisone (MANUFACTURER UNKNOWN), leflunomide (LEFL); all from unknown date for unspecified indication.  The patient had known(Unspecified) allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration on 06Mar2021 at 15.45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 06.30, the patient experienced headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness was not resolved.   No follow-up attempts are needed. No further information is expected.
On 12/29/21 patient to ED with shortness of breath. onset of covid-19 symptoms on 12/22/21 and tested positive on 12/26/21. She was admitted to the hospital for management of COVID-19 pneumonia. Chest x-ray has bilateral infiltrates consistent with Covid. Condition deteriorated and she was transferred to the ICU. Intubated on 1/9/22. Post intubation she had cardiac arrest and right chest tube was placed. Dialysis was done due to kidney injury. Patient died 1/12/22.
Initial and follow-up information has been received from a physician concerning a female patient whose son in 1999 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number not reported).  On approximately 28-JUL-2008 the patient developed chickenpox.  In follow-up the physician reported that there was no adverse event.  "The kids simply got chickenpox after being vaccinated."  It was reported that the patient had routine office visit, no other work up was needed.  Additional information is not expected.
This medically confirmed spontaneous report (initial receipt 26-Oct-2015) concerns an unknown demographics patient. On an unspecified date, the patient received an unspecified flu vaccine (influenza vaccine, manufacturer and batch number not provided) for an unknown indication. On an unspecified date, the patient experienced throat swelling. No additional information provided. The outcome was not provided. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Brand of vaccine not provided. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, throat swelling is unlisted. Causality: Unassessable. Time to onset not provided. Anaphylactic reaction is a possibility, however insufficient information regarding other associated event, investigation and or treatment, hence causality is unassessable.
Narrative: Pt received Janssen COVID vaccine on 5/24. Reported fever and chills approx 24 hours after hospitalization which resolved. Reported diarrhea on day 4 for one night and again on day 6 for one night. On day 7, pt began experiencing chest pain while on vacation. He was evaluated in local hospital on 5/31/2021 for STEMI, flown to another hospital on 6/1 for PCI and post MI care. Per chart review, pt had forgotten his medications while on vacation and had not taken his ASA or ticagrelor for 3 days. He has a significant CAD hx and has had 7 stents placed in the past per family report.
On 9/16/99, the pt experienced tingling, the feet were "asleep" to the knees, cold and numbness to the side going to the vaginal area. 9/99 saw an MD for blood work, and 2 MRI's. The pt was referred to a neurologist. Diagnosis of MS.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccine was stored in the freezer and they would take out one to two vials and keep in the fridge as needed each day. Concomitant product use was not provided by the reporter. Treatment information was not provided.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022 at 20:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative, notes: Symptoms improved and I tested negative; (29Apr2022) Positive, notes: I tested positive again 6 days later. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Plaxovid for the full course. Symptoms improved and patient tested negative. Then some symptoms returned 4 days later, and tested positive again 6 days later.
2 hours post vax pt states she had pain in right arm then to all of body, had chills and felt hot later same day. Spent the night in bed with malaise. On day 3 felt better but still with some pain and fever. Took Tylenol for 24 hours for pain.
It was reported that a pt (4 of 7) received Fluzone 98-99 between 10/3/98 and 10/6/98. Reportedly the pt experienced vomiting and diarrhea.
Pt started c/o dizziness while sitting in observation area.  Gatorade given w/cool compress applied to neck and chest area. A/ox3. V/s b/p 110/88 HR 90 O2 99% on RA. After 5 min pt stated "she is feeling better". Pt denies any compliants and declines EMS services. V/S b/p 110/76 HR85 99%
w/in 2-3 days p/pt recvd vax started developing multiple sx including insomnia though minimal daytime fatigue, lower posterior chest wall & flank pain, worse @ noc; muscle spasms in mid back; lower abdo & pelvic pressure, constipation;
I had a little soreness in my arm after receiving the vaccine for about a day. I had a surgery on 05/09/2023 and by 05/11/2023 I started not feeling well. The worst symptom I had was congestion with slight drip, cough and sore throat. I use a C-Pap, so any respiratory illness is very irritating. It started to move down to my chest with more color and discharge. On 05/17/2023, I went to the clinic at a drug store. I was given three prescriptions plus 2 over the counter medication. I used benzonatate, amoxicillin, albuterol, MUCINEX DM and FLONASE. As of today, I am feeling better with no lingering symptoms.
Information has been received from a physician concerning an approximately 2-month-old patient who was vaccinated PO with a first dose of Rotateq (no lot number provided). Subsequently, within 24 hours of vaccination, the patient experienced diarrhea. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Blood in stool, persistent > 10 days, rotavirus antigen positive in stool.
Patient received a flu shot on 10/15/20 and just came in yesterday 12/21/20 to report the adverse event she experienced with the flu shot. She explained that approximately 90 minutes after getting the flu shot she experienced extreme left shoulder pain that did not go away. She said that she didn't seek medical attention because of  the fear of COVID and didn't want to get out. She contacted her primary care doctor on 10/22/20 because she still had the extreme pain. On 10/26 she had an office visit with her primary care doctor. They referred her to an orthopedic physician. Based on the conversation with the patient, she is still dealing with some pain and will follow up with her doctors. It was concluded from her physicians that she had a rotator cuff injury due to a misplacement of the flu shot.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: 7 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Previously patient received paxlovid the COVID-19 vaccine and Patient exhibiting rebound of symptoms and positive antigen testing 7 days after completing treatment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
about a week after the injection, site became red, swollen, hot, bumpy, extremely sore.
Vaccine given to 1 breastfeeding woman; This spontaneous case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine given to 1 breastfeeding woman) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine given to 1 breastfeeding woman). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine given to 1 breastfeeding woman) had resolved.        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.   N concomitant medications and treatment medications reported.   This case was linked to MOD-2021-009950 (Patient Link).; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Chills - lasted a day Headache - persisted for a few days Soreness across entire body - lasted two days Pain at injection site (on my right arm) - lasted 5 days Redness at injection site (on my right arm) - lasted 3 days
On 6/22 began experiencing mild COVID-19 symptoms but thought nothing of it. Woke up 6/23 feeling worse and tested positive for COVID-19 on at home test. I had low grade fever, congestion, loss of taste and smell, ear pain/pressure, fatigue, scratchy throat, cough, and brain fog. Called doctor's office and I was instructed to ride out at home. Doctor recommended cough meds, vitamin C, and zinc.
Cellulitis left thigh at DTaP injection site, Redness and swelling. Large 12 cm X 8 cm area of erythema and induration. Augmentin ES 1/2 tsp po BID X 10 days
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 29-AUG-2017, the patient was vaccinated with ZOSTAVAX intramuscular (lot # M037655, expiration date: 29-NOV-2017, dose was not provided) for prophylaxis. Other suspect therapies included sterile diluent intramuscular (lot #, expiration date and dose were not provided) for prophylaxis. The patients did not experienced any adverse events.
1st day - body aches, dizziness, fatigue 2nd day - nausea, stomach pains, dizziness, fatigue, body aches
On 2/2/10, on administration of vaccine, approx ? 1/2 of dose leaked/squirted out the sides of syringe at needle base, so only approx 1/2 of vaccine was administered. No adverse event to pt. Called Novartis and they said we could revaccinate to make sure has full immunity to H1N1. Left msg for pt to call re revaccination. May return for 2nd shot this wk. (Vaccine was transferred to retractable needle syringe b/c had no available single needles. Vaccine leaked out of dose of syringe on administration. Follow-up informaiton received states * (No adverse event occurred). 2/2/10 was date of pt. rec'd vaccine where had defective syringe/needle base and approx. 1/2 leaked out from syringe. No reaction from vaccine administration to pt. Novartis was called and they advised/instructed to give 2nd dose to make sure pt. has full immunity to H1N1. Advised not necessary to wait 1 month and could be revaccinated immediately. So, 2nd H1N1 dose (Novartis) given 2/13/10.
This spontaneous report was received from a physician regarding a 19 year old (also reported as 20 years old) female patient. Her concurrent conditions included herpes type 1 positive (diagnosed in November 2016), herpes type 2 equivocal (diagnosed on 02-MAY-2017), and genital herpes. She did not have other medical history and concomitant medications. On 02-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot # M042853, expiry 17-JUL-2019) in the left deltoid (dose and route unknown) for prophylaxis. On 02-MAY-2017, the patient complained of severe arm soreness described as "patient was unable to fully use her arm without pain". On the same day, the patient also complained of tenderness at the injection site (injection site pain) and aches. The patient did not receive treatment for the events. No lab diagnostics/studies were performed. The patient never received her second dose of GARDASIL 9. The outcome of pain in extremity, injection site pain and pain was unknown. Causality of the events was unknown with GARDASIL 9. This is one of three reports from the same physician (1804USA012047 and 1804USA012316).
Pt had series of symptoms starting a couple days after vaccine including SOB, chest pain (went to ER), myalgias, chills. PCP concerned for inflammation of the myositis following COVID vaccine. Stated on prednisone. PCP recommends patient not receive further COVID vaccinations.
3/12/13 Call taken by PSA and info given to this RN. Called patient back at given number. Patient states getting his Pneumonia injection yesterday and today his lt arm started to swell from the shoulder to the elbow. Also states the area is red and warm and tender to touch. Informed patient of system recommendation of 12 to 24 hours. Patient to be seen tomorrow. 69 yo wm who received PNEUMOVAX 3/11. Developed some swelling and redness at the site. Was sore. No fever or chills. Today the redness/swelling has tracked down past the left antecubital fossa. Only minimal warmth. No more pain. Getting better. Medication changes: OTC BENADRYL 25 mg Q 6 prn.
The evening of the day the pt received vaccine she developed approximately 5cm swelling, aching at site of injection and a warm, red "patch" developed. No fever. The swelling worsened over 2 days and red patch grew to encompass the entire back side of arm from injection site to elbow. She sought out MD on Saturday and took BENADRYL. By May 5th when the student came back to see nurse, the swelling had mostly resolved as did the redness and pain.
HUGE headache for 3 days Sore and stiff muscles for 3 days 101 temperature, body chills and aches for 1 day upset stomach for 2 days tiredness for 3 days
C/O pain and numbness in right arm - droop at right wrist - Mon took to dr - student ok
Friday 3-13-09 Body aches, fever, left arm swelling, red & warm to the touch.  Pt given BENEDRYL & on 3/16/09.
Patient had ED visit 23 days after receiving covid vaccine dose #2 and was hospitalized 24 days after covid vaccine dose #2.
Days after the shot my right leg collapsed, feeling like every bone from my hip to ankle had shattered.  Ended up in Emergency Room.  It was determined to be sciatica.  Within that same month, 2 other family members also diagnosed withsciatia after getting booster shot.
Information has been received from a nurse practitioner concerning a 24 year old female with allergic rhinitis, asthma, gastric ulcer, anemia and migraine and a "history of high-risk HPV' who on 10-JAN-2007 was vaccinated with the second dose of Gardasil vaccine (yeast) (lot#655165/1425F), 0.5 ml, one time, IM. Concomitant therapy included NUVARING, ZYRTEC-D and NASAREL. Initial vaccination of Gardasil vaccine (yeast) was received on 16-NOV-2006. On 10-JAN-2007, the patient developed throat tickle, chest redness, itchiness, chest and neck hives and intermittent shortness of breath 15 minutes after administration of Gardasil vaccine (yeast). The patient was administered BENADRYL and the symptoms resolved after 10 minutes. The patient left the office in good condition without residual problems. Throat tickle, chest redness, itchiness, chest and neck hives and intermittent shortness of breath were considered to be other important medical events. Additional information has been requested.
Case number PHHY2011US28383 is an initial report from a health care professional received on 05 Apr 2011 with a follow up from a health care professional received on 21 Apr 2011: This report refers to an adolescent female patient. The patient received vaccination with MENVEO (batch number M10030) on 28 Mar 2011. The patient received the MenA lyophilized conjugate component of MENVEO reconstituted with a sterile diluent; patient did not receive the MenCYW-135 liquid conjugate component of MENVEO. The powder component of the vaccine was mixed with another diluent instead of the one that came with it. No adverse event had occurred. The outcome of the event was reported as patient completely recovered. Follow up received on 21 Apr 2011: The patient's demographic, event description and outcome of the event was updated. Follow internal review on 05 May 2011, it was noted that the significant follow up tick box was not ticked for the previous dates. Hence, the check box was ticked now and the reports for the previous dates were generated.
Patient developed cellulitis following pneumococcal vaccination injection. Right arm became red, swollen and very painful. Patient states, it appears infected and I can barely move arm.
This spontaneous report was received from a health professional referring to unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (Lot# K011562, expiration date 08-APR-2017; Lot# L035105, expiration date 14-MAY-2017). No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of two reports from the same source (1603USA007484). Additional information has been requested.
Started feeling dizzy, unstable, 4-5 days after 1st Moderna shot.  On 6th day, early evening, the dizziness got worse and I had to stay in bed because every time I opened my eyes, the room was going around in circles.  The next morning, I still felt strange, but I was able to get up without the room going around, and feeling dizzy.
Got the vaccine, there was no pain, the shot was fine, no reaction.  Waited for 30 minutes due to his extensive allergies.  Went home and about 2 hours later he noticed when he was moving around it started to get painful just opening a door, etc.  It continually got worse, and maybe 3 hours later in the evening the pain got really bad, and it seemed to be more in his shoulder area.  Gave the shot kind of high, and the pain was real bad in the shoulder and could not raise the arm or use it much at all.  It was also a throbbing pain where he could feel his pulse with the pain in the shoulder.  It was almost like they hit a nerve.  He is still trying to get over it on day #5.  Each day it is starting to get better.  By Sunday the pain was letting up so that he could use his arm.  He is doing stretching exercises walking up the wall and it's complicated.  He has a history of shoulder surgery and had a total replacement in the right shoulder, and wonders if his pain is related to the bad shoulder and the cartilage being bad in that shoulder.  He is supposed to have surgery on it.  But the arm is better, can lift it 75%.
Headache, sore throat, fever, body aches, exhaustion (became progressively worse throughout the course of the day). Fever remained above 100 until ibuprofen was administered. On 1/11/2010, child had to stay home from school due to ongoing symptoms.
vaccine potentially administered subcutaneously; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine potentially administered subcutaneously) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine potentially administered subcutaneously). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine potentially administered subcutaneously) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was provided. No treatment medication details was provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2021: Follow received and contain no new information.