chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke. It was reported that, "same with my Mom. Her legs went out from under her to a stroke the week after shot. so sorry for your injuries." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221244092.; Sender's Comments: V0: 20221244027- Stroke. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Headache, Myalgia,  fatigue, swollen glands. Arm pain with redness and swelling
Cellulitis; right wrist area started swelling; painful to touch; Tender; bit of a rash; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OEDEMA PERIPHERAL (right wrist area started swelling), PAIN IN EXTREMITY (painful to touch), TENDERNESS (Tender) and RASH (bit of a rash). On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis), OEDEMA PERIPHERAL (right wrist area started swelling), PAIN IN EXTREMITY (painful to touch), TENDERNESS (Tender) and RASH (bit of a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Treatment information was not provided. For event of Cellulitis, the reporter assessed causality as not related. For events, right wrist area started swelling, painful to touch, tender and bit of rash, the reporter did not provide any causality assessments.  Company Comment  Based on reporter's causality of recent hospitalization for the event of cellulitis in the non-vaccinated upper limb, is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Turns out it was cellulitis from a recent hospital visit and not related to the vaccine at all.; Sender's Comments: Based on reporter's causality of recent hospitalization for the event of cellulitis in the non-vaccinated upper limb, is assessed as unlikely related to mRNA-1273.
Vax'd on 10/15/02. Also started whole milk for first time on 10/16. On 10/22 PT got a few chicken pox. On the 24th at 3 a.m. she broke out into severe hives. The hives did not affect her breathing. There was no wheezing or fever. She just had horrible locking hives (welts) from head to toe. One was the size of a baseball on her belly. We had to call hospital and gave her 4 ml of Benadryl every 6 hrs. The hives lasted 4 days. They did not go away until PT's mom stopped giving her whole milk. She was on Iscinil since 10 days after birth. Similae (?) at birth made her gassy and fussy. Her pediatrician made up to go to an allergist. On the day of her hives she had a little egg. They thought she may be allergic to milk or egg. These allergies have been ruled out. She now drinks whole milk ? (a copy of specialist's report) is exe?sed. PT's mother thought they should know about this. It is really inconclusive tra? ? caused this. But they could have?
urticarial rash @ site of inj w/in 8-10hr;tx w/antihistamines;
Day following the shot, joint pain in right knee and left shoulder. Symptoms still present but pain has decreased. Eczema aggravated at beginning of series.
pt recv vax 19APR96 & 27APR96 pt devel a fever of 102 & a rash in diaper area;By 1APR96 rash had spread to trunk & back & then from head to toe;
patient vaccinated jynneos intra-dermally.  wheal was not present. pt was revaccination. No SE reported.
This spontaneous report as received from a physician via a company representative, refers to a 60 year old female patient. Medical history and drug allergies/reactions were not reported. On 19-AUG-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot were not reported) to prevent shingles. No concomitant medication was reported. On 01-SEP-2013, the patient applied an unspecified lotion to her bilateral arms and legs. On 02-SEP-2013, the patient noted itchy, inflamed blisters to her bilateral arms and legs. On 04-SEP-2013, the inflamed, itchy blisters were not improving; the patient went to an unspecified urgent care facility to have them evaluated. The unspecified practitioner at the unspecified urgent care facility stated that he/she felt the blisters were caused by the unspecified lotion and prescribed an unspecified antihistamine and topical cortisone lotion to manage the symptoms. On 06-SEP-2013, the blisters were not improving while using the prescribed treatment ordered by the unspecified practitioner, so the patient decided to consult her physician (reporter) who stated to the patient that she felt it was a case of shingles and prescribed a 5 day regiment of prednisone (manufacturer unknown) starting dose of 40 mg per day (on 06-SEP-2013) and weaning the dose down by an unspecified amount for the rest of the 5 day course. On 13-SEP-2013, the patient called the physician (reporter) to report she noted the blisters on her torso. None lab diagnostics studies were performed. At the time of the report, the patient was improving with the blisters starting to resolve. Additional information is not expected.
Pneumovax 23 (lot # L012215) was administered on 10/6/15 by SC injection in the right arm. Additionally, influenza vaccine (Fluzone, Lot #UI439AB) was given on 10/6/15 as an IM injection also in the Right arm. Patient has complaint of pain and swelling at pneumonia vaccine site on arm. Injection site is tender, and warm to the touch.
Pfizer on 2/5 and 2/26. Positive on 9/22
Chief Complaint   rash  History of Present Illness     Rash  on L back/hip  x 1.5 weeks  red bumps, at low back, buttock and back of thigh, last new lesion 2 days ago  pain on the L thigh  discomfort on the back of knee and back of thigh   h/o shingles in 20's  h/o zoster vaccine 2019   immunosuppressed for RA, PA   no itchying  still developing more spots  no fever   gardens  but hasn't done anythign to trigger back/leg pain
On 4/25/01, telephone call from mother, stating child seen by doctor on 4/25/01 concerning body rash which started on calf X 3 days. Also, had "flu-like" symptoms; blistery rash at site of HIB & Hep-B (RD). Doctor dx'd "5th venture", per mom. Discussed soothing methods; Benadryl, Tylenol and soothing bath. On 5/15/01, mom called stating rash covered body and had increased coughing and increased crying. Child was hospitalized X 1 day for observation.
Started with tiredness, chills, fever of 101, and shivering including back ache. Progressed to dizziness, discombobulation, flush in the face, progressing further to restricted breathing and swelling of the face. This Shingrex vaccine is rough, though spouse got it at the same time without so many side effects? so it?s me, I guess. I?ve not gone to the doctor because, hey, what can they do now.
Parent had requested Immunization records from pediatrician, and HD had sent record request/ on 8-28-07. Mother called Dr's office, told her child had never rec'd vaccinations there when she came to the health dept. we called and was told the same thing. We started her immunizations as though she had never had any and gave her Pediarix for her 1st DTaP, IPV, Hep B. On 9-24-07 She sent the attached form from the PCP. The Pediarix was given as a "booster", but unintentionally and through no fault of the health dept
On the 26th I experienced a TIA (mini-stroke) though I have no risk factors.  It was one week after my second Pfizer shot.  I couldn't see out of my R eye, like bright white light--snow blind, then I couldn't decode the words I was trying to read on my computer email.  Then I got up and walked around, made a call and on the call was unable to say the word I wanted to say (Aphasia).
Patient complaint of difficulty breathing, shallow breathing, feeling weak, difficulty talking after the 2nd dose of Pfizer vaccine. Pharmacist lay patient  with legs elevated. Called 911 immediately. 1 dose of 0.3 ml epinephrine given on right thigh(ndc 001151694-30 lot g201101x) monitored bp and hr every 2 minutes. Vitals remain stable and paramedics arrived to release patient.
Patient started with diarrhea on Sunday she was having 10-12 stools a day by the following Thursday she had a 104+ fever and we went to Pediatrician they said she had a viral stomach bug.  Sunday 10/3/10 fever was gone she woke up from nap with a rash all over trunk, neck, and face.  She currently has rash and low grade fever. She is lethargic with no appetite and seems to ache.
9/17/99:Pt recv'd 1st dose of Engerix-B vax.10 days later,he dvlped a petechial rash;also high blood sugar and was hospitalized.10/19/99:Pt recv'd 2nd dose of vax & dvlped flu-like symptoms.Tx w/prednisone after 1st dose.
Received immunization 9/11/08- PEDIARIX, HIB, PCV7,ROTATEQ. On 9/18/08 baby had diarrhea and blood in stool x 4. Day before had increased frequency but not diarrhea. Bm 9/18 is running. Baby acting normal, eating normal no fussing, tummy not hard and swollen by report was receiving Tylenol. On 9/25/08 baby was ok and did ok.
Two hours post vax, pt developed shaking chills and some chest pressure. Over the next 2 days pt had nausea and was hot and cold.
Inappropriate age at vaccine administration; patient had hives after GARDASIL 9 was administered; This spontaneous report was received from a pharmacist, referring to a 29 year old female patient. The patient's pertinent medical history and concomitant therapies were not reported. Her historical drugs included naproxen (NAPROSYN) and her drug reactions/allergies include that same therapy.  On 05-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate age at vaccine administration) as prophylaxis (valid lot number R024259, expiration date was not reported but upon internal validation established as 30-MAY-2021) (strength, dose number, route of administration and anatomical site of injection were not provided).         On approximately 10-NOV-2019 (also reported as "5 days after administration"), the patient experienced hives (urticaria). The patient received treatment with diphenhydramine hydrochloride (BENADRYL) and an unspecified hydrocortisone cream.  On 11-NOV-2019 (also reported as "yesterday"), the patient was started on methylprednisolone (MEDROL) dose pack, and at night of the same day (also reported as "last night") the patient went to the Emergency Room (ER) and was treated with unspecified intravenous steroids and unspecified antihistamines; it was unknown by the reporter if the patient was admitted to the hospital or if any laboratory diagnostics or studies were performed to the patient.  At the time of this report, the patient had not recovered from urticaria. The outcome of inappropriate age at vaccine administration was unknown.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration and the event urticaria, was not reported.
SHAKING; CHILLS; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient experienced shaking. On 15-MAR-2021, the patient experienced chills. On 15-MAR-2021, the patient experienced injection site soreness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and injection site soreness on 16-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210840442 and 20210840671.
PNEUMOVAX given 2/27/12. Two days later noted tingling in both hands. By 3/3/12 noted intermittent tingling arms, hands, legs, feet & face. Comes & goes but present on a daily basis - changes all the time. Bad headache x 5 days after the shot - resolved.
Severe Diarrhea; Soreness under the arms; This is a spontaneous report from a contactable consumer ). A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8733), via an unspecified route of administration in right arm on 31Mar2021 (at the age of 57 years) as dose 2 single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN61GG or may be 99 not clear) via an unspecified route of administration on 10Mar2021 (at the age of 57 years) as dose 1 single for COVID-19 immunisation and experienced little diarrhea. It was reported that patient called to report side effects other than listed on the paper. On 31Mar2021, the patient experienced severe diarrhea. On an unspecified date in 2021, the patient had soreness like soreness under arm. It was kind of sore under arm not where the shot was but underneath arm. Patient received treatment for severe diarrhea with loperamide (IMODIUM 2 mg, frequency: 3). The outcome of events were unknown.  No follow-up attempts are possible. No further information is expected.
48 hrs p/vax pt fever went up to almost 106t R had chills; dx w/pneumonia per x-ray; recvd ATB;
Aphthous ulcer formed under tongue on left side a day after receiving booster shot of Pfizer. Treated with dexamethasone swish and spit. Same reaction occurred after 2nd dose of Pfizer.
This spontaneous report was received from a pharmacist refers to a 71 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly rather than subcutaneously. The pharmacist reported that the patient received the ZOSTAVAX at another unspecified facility late last week (date of administration unspecified). The pharmacist reported that the ZOSTAVAX injection site was bruised and raised. The outcome of injection site was raised and bruised was reported as recovering. Additional information is not expected.
Gave the patient 0.5 mL as a booster dose instead of the CDC recommended dose of 0.25 mL. The patient is not immunocompromized and therefore, did not qualify for the third dose but did qualify for the booster dose due to occupational risk.
Janssen COVID Vaccine dose administered on 5-19-21. When entering into alert it was discovered Patient received a COVID vaccine dose on 4-10-21, unknown trade name, lot EW0158.
As soon as vaccine administered, patient stated he felt like he was going to faint. RN grabbed his shoulders, he fainted in chair and started snoring. RN lifted his head to open airway and pt started convulsing and turned bright red. RN yelled for help. RN leaned the chair back to lay on the floor, holding patents head so it would not hit hard. Pharmacy worker called 911. Pt stopped convulsions and started coming too then turned very pale. He said he was starting to feel better but wanted to remain laying on the floor. When paramedics arrived they assisted him up in a chair, took his vitals, he was stable. Then checked his blood sugar and pt immediately passed out again. RN again assisted to lay him back in the chair to be flat on the floor. He again became very pale. Paramedics placed him on the gurney and took him to ER to be evaluated.
Red spots slightly raised on body increased after several hours.  Fussy for 1 hour after shots & oral suspension.
Red, itchy rash beginning on the 7th day after the vaccine. It is persisting and spreading slightly 6 days later
Patient reported no initial reaction, however, the following morning injection site redness, swelling, welting, hot feeling began. The reported symptoms have continued for 3 days post-injection at this time.
12/18/2020: COVID19 vaccine received. 12/19/2020: Patient noticed petechiae/bruising on arms, legs and face. Worsened over next 48 hours. 12/21/2020: Patient had blood drawn (CMP, PT/INR, CBC) at lab. 12/22/2020: Labs resulted; CMP and PT/INR WNL (exceptions: SCr 1.24, TBil 1.7); CBC with platelet count of 1,000 resulting in patient admission to Hospital. At admission he received 80 mg of prednisone, 40 g of IV Ig and a unit of platelets. 12/23/2020: Continued hospitalization. Patient's platelets improved to 20,000 and he received another 35g of IV Ig. 12/24/2020: Patient discharged with platelets of 38,000.
Pain in arm muscle immediately after immunization. Calling a month later and still experiencing pain in arm. No medical follow up.
I got the shot at 4:00 on friday and had no immediate adverse affects. Saturday I woke up not feeling very good but not terribly bad, had a bad headache and arm pain where shot was administered.  Glands in underarm on shot side were swollen.  By mid afternoon, I was feeling pretty bad.  Stayed in bed.  By Sunday morning, I was running a 101 fever, severe headache, nausea, body aches and pains, and chills.  Stayed in bed all day and took Naproxen for the affects.  Not much eating or beverages.  By Monday I felt a little better, no fever, no headache, still nauseas but manageable.  I had adverse reactions to all 3 shots I have taken.
pt brought to Ed with c/o worsening SOB x 1 wk, saw PCP (name not found in medical records) and was treated for pneumonia; in ED pt also c/o nausea, D/V; O2 sats 73% on RA; tested positive for COVID; admitted; AHRF; given steroids, remdesivir, baricitinib, O2 supplementation; need for O2 increased; found to have a right upper lobe PE; pt requests DNI; does not want BiPAP; CPR is ok; pt eventually chose comfort measures only and she passed away in the hospital
Localized redness, induration development of a small 2-3 mm bullous lesions.
Nurse reports RECOMBIVAX HB that expired 1/25/2023 was administered to one patient today 2/3/2023. Product has been stored at the appropriate storage condition, specified in the product label, through the date of administration. No additional AE deta; This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications  On 03-FEB-2023, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot  T025374, for prophylaxis (route of administration was not reported).  The dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) expired on 25-JAN-2023. Product had been stored at the appropriate storage condition, specified in the product label, through the date of administration.
Myalgia, NauseaVomiting, arm soreness, chills, fatigue
pt recv 2 doses of vax & failed to seroconvert;lab eval revealed a titer of 0.14;
Patient presents rash in both arms after 11 minutes of being immunized. We offered primary care.
p/vax pt inj site became red & infected; devel rash on rt knee; cold symptoms; & fatigue; leg swollen w/painful rash on leg, not itchy; T99.6; was Dx w/lyme disease
Hives on Rt foot up to knee & thigh area, and Rt arm. Benadryl given 11/21/22 evening time & 11/22/22 am before coming into clinic. Advise to cont Benadryl OTC liquid & get OTC Benadryl cream, vaccine added to allergy list.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored PEDVAXHIB (lot #, expiration dates, doses and routes were not reported). No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Site: Pain at Injection Site-Severe, Additional Details: Left arm pain since injection given on 9/14/22.  Radiates up and down arm.  Advised to take advil and use ice pack.  Also advised to visit doctor again.
Moderna  COVID-19 vaccine EUA Developed throat, cough and throat clearing during observation period.  Refused epinephrine.  Code assist called and person was taken to ED where received Solumedrol, famotidine, Pepcid, and Benadryl;  continued to refuse epinephrine in ED.  Symptoms resolved and discharged home.
Her husband would like to receive Johnson & Johnson for second dose instead of Pfizer covid vaccine; chills; vomiting for 24 hours; fatigue; head ache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer or other non hcp (patient's wife) reported for a male patient (reporters husband) that patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 22Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date Feb2021, the patient experienced chills, vomiting for 24 hours, fatigue, head ache, and her husband would like to receive johnson & johnson for second dose instead of pfizer covid vaccine. Caller wants to know if it would be safe to receive Johnson & Johnson covid vaccine for second dose instead of Pfizer covid vaccine. The outcome for all the events was unknown.  Information on lot/batch number has been requested.
Covid Positive - Fever, Cough, Cold Symptoms, Achy Body, Exhausted
Had expected arthralgia and myalgia for 5 days. Unexpectedly awoke from sleep with severe shaking chills about 12 hours post injection which resolve after an hour with the administration of oral TYELNOL. Chills did not recur.
Suddenly blacked out and fell; mild concussion and soft issue injuries to right side of body; extreme fatigue and nausea.
Lump under the skin at injection site, diameter of tennis ball, red, swollen, hot, itchy and very sore.