chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after two weeks of receiving 2nd shot I developed severe joint pain in hands shoulder calf knees feet it comes and goes moderate to severe.; I tested positive for Rhumatoid Arthritisand I am waiting; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 42-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left in Mar2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  Medical history included atrial fibrillation (AFib), high cholesterol, high blood pressure (BP) and gluten sensitive, all from an unknown date and unknown if ongoing. No known allergies.  The patient did not experienced COVID-19 before vaccination and not tested positive to COVID-19 since vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Mar2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  The patient reported that: "after two weeks of receiving 2nd shot (in Apr2021), I developed severe joint pain in hands shoulder calf knees feet it comes and goes moderate to severe. I tested positive for rheumatoid arthritis and I am waiting for treatments". The events were reported as serious, disabling. The events required doctor or other healthcare professional office/clinic visit. The patient outcome of the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning an approximately 13 year old female who on 30-DEC-2009 (lot# 662229/1497Z, Exp 15-APR-2011), 06-MAR-2010 (lot# 658271/0558X, Exp 21-MAR-2010), and 05-JUL-2010 (lot# 661530/0575X, Exp February 2011) was vaccinated IM into left deltoid with a first, second, and third doses of GARDASIL. The patient's menstrual cycle was delayed for 4 to 5 weeks after her second dose of GARDASIL. The patient told nurse that her menstrual cycle did resume. The patient's outcome was not provided. Additional information has been requested.
Pain at injection site persisting 16 days afterwards - resulting in avoidance of use/spasms.
Presented with SOB, cough, chills, headache; Covid+ ED; admit for Covid 19 (no pna); tx with Vit C, Rocephin, Vit D, steroids, zinc, minimal supplemental O2
fever, rash, h/a 12 days p/MMR vax;temp as high as 103.5;rash appeared on neck, chest, arms, trunk, raised red, 1-2mm in diameter;no photosensitivity no nuchal rigidity;
Arm pain and swelling at injection site that radiates to elbow and shoulder blade. Joint pain, trouble sleeping, fatigue, fever over 101°, swollen lymph nodes in neck, body aches, chills, tight jaw, headache.
Face is numb and tingly; Face is numb and tingly; This is a spontaneous report from a contactable non-health care professional, the patient. A 53-years old non-pregnant female patient received BNT162B2 (BNT162B2) (Lot/batch no: EP7534), via an unspecified route of administration on the left arm, as second dose, single on 16Mar2021 at 09:00 (at age of 53 years old) for COVID-19 immunization. Medical history included hypothyroidism. Past drug included BNT162B2 (BNT162B2) (Lot/batch no: EL9267), via an unspecified route of administration on the left arm, as first dose, single on 23Feb2021 at 10:00 for COVID-19 immunization. Concomitant medications included levothyroxine. Allergies included allergy to sulfa drugs. Prior to vaccination, patient had not been diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 09:15, the patient experienced numbness and tingling on her face. The patient did not receive any treatment for the events. The patient was not recovered from the events. No follow-up attempts are needed.
Two days after receiving the vaccine I developed ringing in my left ear. It waned and then resumed after the 2nd Pfizer shot. It again waned and then upon receiving the booster it has been on blast since 10/29/21  and has yet to subside.  I have been to my GP, Dentist and an acupuncturist.
24 post vax pt devel inject site rxn w/ swelling, redness, warmth and tenderness.
No additional AE; the syringe broke cleanly; while needle was still inserted into patient; This spontaneous report was received from a nurse referring to a 1-year-old female patient. The patient had no pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications (all reported as "none").       On 03-AUG-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL / single or four dose series, intramuscular (IM), lot # X005583 with expiration date 10-DEC-2024, for Pneumococcal prevention (strength and anatomical location were not reported). No additional adverse event (AE) was reported. Nurse reported that after administering pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) to the patient, the end of the barrel where the needle screws into the syringe broke cleanly off once administration was completed while needle was still inserted into patient. Nurse stated that the patient involved was not harmed as a result of the syringe breaking and the complete vaccine was administered to the patient. Nurse stated that the syringe in question was disposed of per facility protocol, therefore no sample was available to be retrieved.
Seen1/12/07 for well checkup-received (4) vaccines(MMR,Varivax,HIB,Prevnar). About 1 wk. later, patient was seen in Mease Countryside ER for fever 104.6 for 2 days,fussy, staring episode-labs,Xray,spinal tap done to R/O meningitis-received Rocephin antibiotic. F/U visits to MD ofce on 1/22,1/23. Rehospitalized for irritability on 1/23/07. 02/02/07-records received and reviewed for DOS:01/23-01/26/2007 DC DX: Irritability, resolved Gastroesophageal reflux, now on Prevacid Mild upper respiratory infection, on nasal decongestants History of megacephaly and hemispherectomy HX:2 year old with history os seizure disorder, had a left hemispherectomy fin early infancy for intractable seizures. Born with megacephaly. Post surgery developed aseptic meningitis. Currently not taking seizure medications. PE:extremities show some weakness on the right side, no posturing is noted. Status post ear infection. Reported fever of higher than 104. In ER 100.4. Diarrhea status post course of antibiotics for otitis media. EEG: abnormal study because of presence of suppression of the left hemisphere consistent with left hemispherectomy. Supine abdomen:grossly normal abdomen.
This spontaneous report as received from a nurse refers to a 10 months 24 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Presents w/vomiting & diarrhea x5 days, cough & body aches. Admit for COVID/COVID pneumonia. Tx: IV/oral dexamethasone, Zinc, Vit C, heparin, not candidate for remdesivir or CCP (did not demostrate signs of clinical deterioration due to COVID). DC'd to SNF.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.   No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
pt recv vax 25JUN98 & pt exp burning, swelling & redness @ the inj site;pt was not acting self & pulse went up to 140 & BP was 180/110;seen in ER given 02 & DPH & hot/cold packs were applied @ site;also exp nausea;pt arm still red & swollen
fatigue; Fever 103.6/fever 100.3; headache; chills/chills with fever 100.3 after ibuprofen; Sore at injection site; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 14:30 at single dose for COVID-19 immunization. Vaccine location was Left arm. Medical history included migraine, transient ischaemic attack (TIA), allergies: Penicillin, the patient had covid-19 prior to vaccination. Concomitant medication included buspirone hydrochloride (BUSPAR), cranberry, vitamin c (ascorbic acid), colecalciferol (VITAMIN D). The patient was not received other vaccine in four weeks. The patient experienced Sore at injection site, body aches, chills with fever 100.3 after ibuprofen, headache on 18Dec2020 19:00. And then the patient had Fever 103.6, headache, chills, fatigue on 18Dec2020 19:30, sore at injection site on 18Dec2020 19:00, body aches on 18Dec2020 19:00. Therapeutic measures were taken as a result of events fever and chills, no treatment was received for the other events. The outcome of the events was recovering. All events were assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
on evening of vax pt had fever, vomiting; fever peaked during noc >105; had 1 sz; pt taken to ER dx w/ear infect;
Large egg-sized mass on R deltoid. Whole body weakness, headache 6/10 sharp and intermittent, body aches and chills. No fever, cough or N/V.
Swollen , painful lymph nodes underneath armpit and underside of arm. Started as slightly tender and now has  increased to encompass whole upper arm being painful and having trouble moving the arm.
Large area of redness, very inflamed and swollen, double the size of his other arm, very hot to the touch.
Hospitalized (11.28.21 - still currently admitted); COVID-19 positive (11.28.21);  Fully vaccinated plus BOOSTER HISTORY OF PRESENT ILLNESS: Patient is a 71 y.o. male PMH of splenic B cell lymphoma, Hx of LLE DVT (was on eliquis and off receiving chemo, cholangitis sepsis in 10/2021, type II DM, HTN, who presented to ED with his wife with complaints of progressive confusion and AMS concerns, as well as weakness. Most of hx is collected from the wife who is bedside, but patient does add to it. They state patient has received his flu shot on 11/21/21, and was doing well, but on Wed 11/23 started to feel worse, tired, fatigued, and at this time has rec'd tx in office. He cont to have progressive weakness, per wife also has had fevers >101F, and a fall - was not witnessed (unsure if he hit his head, not on blood thinners). He has been having diarrhea on and off. Not eating much. Due to all above, his wife decided to bring him to the ED. In ED work up as above noted positive covid test, but most of rest work up neg, blood cult pending, given zosyn, and decadron in ED, and IVF per sepsis protocol.  On my eval, patient sleepy, but responds appropriately, he just had benadryl as he is allergic to contrast, so had been pretreated for imaging. He states he feels poorly, achy, tired, had mild SOB, no cough, and no pain anywhere. Has on and off diarrhea as mentioned, and no other sx.  will give remdesevir and cont dexamethasone, might need compassionate use of Regeneron (as patient is high risk of getting worse and getting re-current covid infx, due to inability to amount good antibody response), will re-assess tomorrow and see the O2 needs.  No obvious infectious process per imaging, will re-image later today post hydration to assess for PNA -- CXR ordered., in the mean time vanc/zosyn, and follow up on cultures.  Supportive care and monitor closely
fever up to 100 started 22FEB97;rash started 23FEB97 w/erythematous maculopapular gen;
Systemic: FAINTING - LOSS OF CONSCIOUNESS FOR A FEW SECONDS AND HIT HIS HEAD. BITTED HIS TONGUE.-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: PARAMEDICS CAME. HE WAS FEELING MUCH BETTER. HE WAS RESPONSIVE.
1400 Mom called, said left thigh swollen, red, warm from hip to 1/2 inch above knee.  Rec: ice to site, Tylenol
I had feverish symptoms - 99.6. Body aches were worse this time and headache was worse this time than first dose. It lasted until Monday the next week - so that was until January 25th when I finally started feeling normal. Tylenol was taken - 1000 mg - I took it every 6-12 hours. That helped. I also added benadryl - 25 mg - I took that every night because I was having a hard time going to sleep with body aches.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L023936, exp. date: 15-MAR-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
ADMINISTERED THE Dark pink cap; yellow label border INSTEAD of Dark blue cap; gray label border as indicated by the CDC
Vaccine administered at 9:15AM, rash reported from cheeks down to torso by mother at 6PM; rec. MD antihistamines (fexofenadine).
Patient is having trouble moving arm out to side.  Unknown date of when it started or time but started after vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX (batch number TZ9L5, expiry date 22nd November 2020) for prophylaxis. On 20th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and was having arm pain, till the time of reporting. The patient had notified his physician and no cause for the pain could be identified. The reporter was transferred to medical information system for discussion on pain seen beyond what noted in the product information. The reporter also stated he had heard of several other individuals that had complained about pain for weeks afterwards. The reporter also noted a lot of people complained about pain with the vaccination. This case was linked with US2019GSK041727, reported by the same reporter.
Soreness in upper arm; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 09:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no 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. The patient did not take any concomitant medications. The patient did not receive other medications within 2 weeks of vaccination. On 01Mar2021 at 10:00, the patient experienced soreness in upper arm. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt came in to get booster shot. over 24 hr after shot pt complained of fever, headache, and joint pain. pt fever resolved since took ibuprofen but headache and joint pain still unresolved. told pt to go to md since its odd for her to have these sx at her age even though could occur for up to 3 days after booster shot. pt said also no sx after first two shots. pt will see md asap.
Patient was admitted to the hospital 4 days after the dose with gram negative bacteremia from a port infection, also found to have an infarction of the splenium of the corpus callosum on MR imaging, acute on chronic thrombocytopenia. DDx include a thrombotic thrombocytopenic process. Patient reports fevers, chills, malaise, N/V starting the morning after vaccine leading up to the presentation to the hospital.
Patient received her first dose of the COVID-19 Moderna vaccine. After vaccine administration, it was brought to our attention that patient received monoclonal antibodies 71 days prior to vaccination. Patient did not have any adverse reaction after vaccination. The next day, 3/11/21, Patients daughter was contacted and reported no side effects. Advised to call back if side effects occur. Patients daughter was also contacted 1 week later on 3/17/21 and said patient was doing well, had some diarrhea but that was it.
9 days after the vaccination I awoke with a large red, rash-like spot at the injection site.  I was awakened by fairly intense itching at this site which measured about 2" by 4".  Topical application of hydrocortisone and an oral antihistamine provided some relief from the itching , but did not seem to affect the rash.
fever 103 while on acetaminophen high pitch scream (crying) from midnight to 6AM; (cried most of that time); vomit breakfast day p/shots (less than 24 hr p/shots);
Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Station where I volunteer. I did and EKG which showed Anterior Infarct. I went to the ER. They gave me 4 baby aspirin to take and some blood work. I was told the blood work showed elevated levels consistent with a blood clot as well. I had a CT scan to rule out a clot in my heart or lungs. Which it was negative. I was released and told to see a cardiologist in the next few days. I saw the cardiologist two days later who said I ended up with Pericarditis and that it should resolve on its own. I was feeling better until two days ago when I developed chest pain again. I again went to my fire station I volunteer for and did an EKG which showed Anterior Infarct. I am currently waiting for treatment from my cardiologist.
Patient received SHINGRIX vaccination on 1/23/19 through Agency. She presented to our office on 3/29/19 with the following concerns: Patient states that on the right side of face mostly near upper lip to check. Patient states that the feeling in right side of face has been going on for about a week. Patient states that the muscles just dont seem to be working well. Patient is not having any issues near eye. Patient has feeling but it feels like it is puffy. Patient states that there is a tickle on right side of nose. Like there is something there. She describes it as like when you have novocaine is wearing off. Yesterday she was unable to drink due to not being able to hold lips closed. Patient didn't notice any dropping of the face yesterday. Patient states that she didn't have any problem with words or any other symptoms. Patient states that about two weeks ago she did have a sore on the right side of tongue but then gone. Symptoms started about a month ago, where she felt like her right side of her lip muscles were not moving properly. When she got up in the morning her lips were tight and didn't look right. Two weeks ago got a horrible cold sore on the right side of tongue that made it hard to speak. 2 months ago had the first shingles vaccine. Now having some more facial assymetry and right eye lid drooping/ weakness. PHYSICIAN SUSPECTS BELLS PALSY LIKELY ADVERSE EVENT FROM SHINGRIX VACCINATION. Plan from visit as follows: Bell's Palsy: Will treat with prednisone 40 mg x 3 days, 20 x 3 days, 10 for 2 days and 5 mg x 4 days. Will also give VALTREX 500 mg twice a day for 5 days. Will have use lacrilube at night to keep eye moist and may want to get an eye patch so eye doesn't dry out. Make take months to get full strength back. Do think there is good possibility that this was triggered by the shingles vaccine, given timing where shortly after vaccine got severe cold sore and started to notice facial symptoms. No evidence of stroke or intracranial event.
Immediately after the 1st & 2nd vaccine, I experienced headaches needing Extra Strength Tylenol  every 8 hrs, muscle aches and moderate tenderness around the injection site that lasted for a good 4-5 days later. Around 4 months later, I experienced moderate to severe vertigo spells needing by mouth steroid and an anti-vertigo prescription medication. 7 months after the first vaccine, I?m still experiencing mild, intermittent vertigo spells.