chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3RD DOSE MODERNA COVID VACCINE GIVEN 11/8/21, LOT #077C21B; 7/24/22 pt brought to regional hospital from SNF; c/o rectal bleeding and bloody diarrhea today; found to be positive for COVID; no tx for COVID needed due to maintained on RA; pt had UTI, given ABX; pt dc'd back to SNF with Hospice where pt passed away
Developed erythematous/swollen area described at at least 60+ mm diameter to (L) deltoid injection site. 4 days later: 40mm. 6 days later: 30mm. Remains without discharge. Pain at injection site area very bad & on 6th day remains tender. Had body aches and (L) shoulder and pectoralis throbbing discomfort. All discomfort now resolved except tender at injection site. No lymph node enlargement tenderness. Had dizziness (not light-headed).
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 85-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased. The patient was treated with non-drug therapy (Hot Compresses) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased to be related to SHINGRIX. Additional information was received as follows: The patient reported being vaccinated with SHINGRIX in left arm at a pharmacy about 9 or 10 days before the date of reporting. The patient stated that her arm was itchy immediately after vaccination. The patient did not specify after vaccination when redness, warmth, swelling and pain extending to the top of the left arm began but reported that it was started about 9 days before the date of reporting. The patient reported that she experienced pain, redness, warmth, and swelling extending to the top of the left arm. The patient had difficulty in moving arm and could hardly use it. The symptoms was getting better. The reporter did not have more information on pain symptoms like pain scale, radiation, sharp or dull. The physician in office recommended the patient to use hot and cold compress to treat the symptoms and increase circulation. The reporter was pretty sure that this symptoms were due to the vaccine. The reporter reported that the patient was doing better on the 9th day. The reporter planned to have patient come back in 5 months to get 2nd dose of SHINGRIX. Upon follow up, MSL (Medical Science Liaison) had called and emailed health care professional (HCP) to learn more about event reported. There were no response from HCP has been received. The reporter was questioning if the patient could still get the second dose 2-6 months later.
The evening after vaccines the leg thigh was swollen and red and warm to touch. The patient developed hives on her chest and abdomen. All symptoms resolved.
I felt tired after receiving the vaccine and my arm was sore for a day. My left eye felt irritated and itchy. The symptoms are all isolated on the left side of my face. I went to an urgent care center and was given two prescriptions prednisone and valacyclovir. I saw my Ophthalmologist and she gave me an ointment prescription. I have a follow-up appointment in a couple of weeks. I do not have pain from the Shingles, but I am still dealing with me.
a little painful; had redness/ has a "big red circle; has a "big red circle", it is bigger than before; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She took the second dose of the Pfizer COVID-19 vaccine on Friday. She said it was a little painful and she had redness. She now has a "big red circle", it was bigger than before. Is this an allergic reaction. Any reports of this and how long was it supposed to last. The outcome of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother states the child was inconsolable and screamed continuously for the entire evening after the two-month vaccines were given (PENTACEL, PCV13, RV5). Mom states this is very unusual behavior for the child, as the child is very calm and quiet usually. Mom states the child had a worse reaction after the four-month vaccines and the screaming continued all evening into the next day.
Itchy arm, back and lips lasted a few hours.  A few days later, hives, wheezing and lump on jaw under earlobe. These symptoms still persist.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA297839 and 2018SA297828 (same reporter). This case involves a nine years old male patient who was inadvertently vaccinated with a dose of FLUZONE HIGH DOSE lot UJ030AB expiry date 05-May-2019 via intramuscular route in the left thigh on 22-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to drug administered to patient of inappropriate age and overdose. It was not reported whether the patient had any adverse event. 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 sender: none.
swelling and rashes on her arm; swelling and rashes on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), RASH (non-serious), outcome "unknown" and all described as "swelling and rashes on her arm". Additional information: She does not have the name, lot, ndc, or expiration date to provide Adverse Event (AE)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) was updated as a device combination product and dosage information.
Patient's description: Arm was red, hot and tender 24 hours after Td injection. Missed 2 days of work. Muscle soreness all over several days. Legs feel like they will give out from under her. Had fever 3 days following injection. Palpitations. Muscle aches have resolved. Weakness persisting.
Developed spontaneous urticaria several days after injection, requiring daily Zyrtec for the unforeseeable future. I have never had reactions like this in the past. I now have chronic urticaria after the injection.
I received my Moderna COVID vaccine on Thursday, May 20, 2021 and at that time I only had a slight fever and my arm was a bit sore at the injection site.     My reaction to the Moderna began in the wee hours of Friday May 21st.  I had a fever of 103.0, I did not go to walk in or my doctor because I took Tylenol and after a few minutes my fever subsided.  I went back to sleep.  Upon waking up I had body aches, a running fever, my head felt like I was in a fog that I couldn?t shake.  I was so tired that I could hardly keep awake.  My fever kept getting worse through out the day so I kept taking Advil (I had stopped taking Tylenol because it had stopped working).   Advil helped a little bit but I felt like my fever would never go away.   This happened through out the entire Friday May 21st.  Then in the middle of the night around midnight Friday into Saturday I began sweating profusely all the while having a fever and body aches and I was really really tired.  When I woke up at 5am Saturday my clothes were drenched in sweat and I felt better, but the entire weekend I had nausea and diarrhea.
pt recv vax & started breaking out w/little red bumps;by 18SEP98 pt was covered entire body w/hives, fever 101.8;itching seen in ER treated w/med;
Temp 104F, "stiffneck", extreme irritability, & vomiting for 12 hrs. It was reported that the patient recovered from this experience.
First dose 09/25/2020. Second dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th September 2020, expiry date 25th March 2022, Batch number NT7YR).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-July-2022 Reporter's comment: The reporter reported a late second dose of Shingrix. Second dose not yet administered at time of call. The reporter consented to follow up.  Additional supportive information: Till the time of reporting the patient had not received 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Morning of 28 January patient felt chest pain/tightness with associated SOB. Work-up at ER including chest x-ray/EKG/ABG/labor normal with exception of elevated CK. Echo normal, Patient did well until night of 29 January where had additional CP with cardiac enzyme elevation (CK 426, CKMB 29.4, Troponin 8.31) EKG/Echo normal but patient transferred as ACS and underwent cardiac cath for further eval. Cath normal, patient felt well post procedure and discharged (Feb 07 with diagnosis of myopericarditis secondary to small pox vaccination. Currently on Motrin and pain free.  03/05/2007 MR received.   Patient presented to the ER with c/o substernal chest pain 10 days following smallpox vax.   SOB only when lying supine, and increased pain with deep inspiration. Temp.=101.8'F. Pt. had occasional intermittent chest pain relieved with medication until 01/30/2007 when he had an episode lasting 1.5 hours with SOB, and corresponding cardiac enzyme increases.  Pt. transfered to another facility for cardiac catheterization. Cardiology consult impression: Suspected myopericarditis related to recent small pox vaccine.   04/12/2007 MR received from transfer facility.   D/Cd after 2 nights in good condition. Discharge DX: Myopericarditis 2' to small pox vaccine.  Angiographically normal coronary arteries.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles and unhappy with developing shingles after receipt of ZOSTAVAX. The patient sought medical attention via physician examination. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has been requested.
Headache; Not feeling well; His legs are warm; Has a stiff arm; The right arm he had the shot in is sore/It is pretty much sore all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "Not feeling well"; FEELING HOT (non-serious) with onset Apr2021, outcome "unknown", described as "His legs are warm"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Apr2021, outcome "unknown", described as "Has a stiff arm"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "The right arm he had the shot in is sore/It is pretty much sore all over".  Additional information: Patient and her husband received the Pfizer COVID-19 shot yesterday (at the time of report, 15Apr2021) and her husband was not feeling well today and she stated his legs are warm and he has a stiff arm. Reporter stated, she was calling for her husband. Reporter's husband and she went to have a shot the COVID-19 one and we went to the (redacted) University and we came back and last night her husband felt fine and she felt fine, arms are little bit stiff but she get up this morning and took a shower and she was feeling fine, no stiffness and nothing, Reporter's husband get up and he doesn't feel good, his legs are warm, he got a headache, the right arm he had the shot in is sore. He said it is pretty much sore all over. Confirmed the vaccine as first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 5JAN96 & 1APR97 & devel varicella w/approx 20 lesions;pt did not exp a fever;pt was seen by MD to confirm dx;
nausea 3-4 hours after, then arm pain, redness below injection site, swollen lymph node in neck and pain along sternum starting the following day
Loss off smell and taste; Loss off smell and taste; Stuffy nose; Sinus pressure; Headache; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and multi vitamins (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. On 08May2021 at 01:00, the patient experienced headache and sore throat. It was reported that on the second day also the patient experienced headache and sore throat. On 10May2021, 3rd and 4th day, the patient experienced loss of smell and taste, stuffy nose and sinus pressure. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10May2021, the patient underwent SARS-CoV-2 test and the result was pending. The clinical outcome of the events headache, sore throat, loss of smell and taste, stuffy nose and sinus pressure were not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
a dose of YF-VAX was administered today, 19Jul2021, using an expired diluent with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician.  This case involved an unknown (age and gender) patient who administered dose of YELLOW FEVER VACCINE - US [YF-VAX] was administered today 19-Jul2021using an expired diluent (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 19-Jul-2021, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot UJ371AB) (Diluent expiry date: 20Jun2021 and Vaccine expiry date: 21Jul2022) via unknown route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that, "Patient information not available. Caller with question on whether dose needs repeating. Requested HCP (health care professional) call back to provide patient data"  It was an actual medication error case (expired medical agent used) (latency same day)  At the time of reporting, no adverse event  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 the 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.
1) developed severe neutropenia on 6/14/17. 2) developed BILIOUS vomiting.
cellulitis, upper arm, felt like fever , swelling, chills, nausea, no problem with first vax.
On 4/15 I began experiencing sharp pains in my chest and left side. I had difficulty speaking. My entire left side including face, arm, leg, foot, were all numb and continue to have intermittent numbness. I went to the emergency room. CatScan with and without contrast are negative for stroke or heart attack. MRI of brain was normal. I have no past history of heart issues.
Patient began with headache, nausea, feeling hot but afebrile. Then aching all over. Given Midrin and Phenergan about 8 PM and slept all night. 4/18 AM sore throat, myalgia, T 99.5. PE with inflamed pharynx. Rapid strep negative. Family has not returned calls on 4/19, 4/20, 4/21. Felt better when contacted by phone 4/18 PM.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 31-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly in the arm (unspecified), lot # L035686, expiration date 16-FEB-2017 (dose was not provided). On an unspecified date in 2016, the patient experienced a reaction described as: injection site arm was red and swollen, tender to touch, with red streak center, pink and dry (diagnosed as symptoms of cellulitis). The nurse reported that the patient sought medical attention on 02-JUN-2016. The patient was prescribed antibiotics of KEFLEX 500 mg, every 6 hours for treatment by a physician. The patient was also instructed to go to an unspecified emergency room if symptoms worsened at the time of the visit. The nurse reported follow up with the patient on 03-JUN-2016 by an unknown provider and the patient stated that redness was improved and the patient was feeling better. The nurse stated that the patient did not seek further medical attention as of 10-JUN-2016 (reported as today). The patient did not have lab diagnostic studies performed. The outcome of the events was considered as recovering/resolving at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
rash appeared on the 17th, started like a bug bite and then turned into a large rash to upper left arm on the 17th.  then noticed a small round lump under left armpit.  on 2-20-20 noticed a large lump under collar bone close to the shoulder, approx size of large egg.
Pt recv vax on 10/9/98; on 10/19/98 pt exp optic neuritis-both eyes; tx=steroids
Rash appeared on left arm November 3rd AM. Eye was red. matted and watery when getting up November 4th at 8 AM. was that way till November 11 when I went to see Dr. November 11 went to Optometrist, Dr, diagnosed as bacterial conjuctivitis and received Ofloxacin eye drops prescription. November 16 went back to Optometrist, Dr. as eye was inflamed and matted again - received Tobramycin/Dexamethasone Susp. eye drops prescription. November 24 went to Dr. as eye was inflamed and matted again and received Polycin Ophthalmic Ointment. November 29 went back to Dr as eye was inflamed and matted again. Diagnosed as Viral Conjunctivitis. Was told to use Over the Counter Systane Moisturizing eye drops. December 5 - Called Dr.'s office, eye inflamed and matted again. Told to use no preservative over the counter eye drops.
fluzone qiv np being administered to a geriatric patient accidentally instead of fluzone high-dose quadrivalent, with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age geriatric female patient who was accidentally administered influenza quadrival A-B vaccine [fluzone QIV] instead of fluzone high-dose quadrivalent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2022, the geriatric patient accidentally received a dose of suspect influenza quadrival A-B vaccine (lot UT7731, formulation, strength, dose, route and administration site: unknown) for influenza instead of fluzone high-dose quadrivalent, with no reported adverse event (wrong product administered).  It was reported "The patient is requesting to know if she should be revaccinated. Caller is on her way to work and will call back when at work with safety report information".  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown.  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 the 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.
pt recv vax 15OCT97 & 31OCT97 pt c/o discomfort in the coccyx & sacrum;
pt woke up on 6/2/2021 and noticed she had a warm red spot on her left arm around the injection site.  The next day it was the size of a half dollar.  It continued to spread down and out on the arm and was still red and warm.  She went to the walk in clinic on 6/6/2021.  Her vitals were normal.  She was prescribed Cephalexin 500mg antibiotic and told to FU w her doctor if it didnt get better.  Pt will contact her MS specialist to let them know about the infection.