chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tonic clonic sz;tx of several anticonvulsants, sz erupted into myoclonic, atonic, absence or petit mal, complex partial, psycho motor;cont to have sz daily & affected speech & motor skills, ?ataxic walk;
At onset-vaccine shot hurt. 15 minutes-red and hurt. Continued to get stiff. Followed up with dr for an xray which didn't show anything. Followed up with another dr and he gave a cortizone shot but it didn't help. Went to the chiropractor today and he said it seems to be frozen. He's going to send her on to a specialist.
patient developed shingles across back and abdomen, no rash but unknown pain for 2 weeks before rash eruption starting 7/12/19, unspecified rash starting 7/22/19, visited ER on 7/12/19, 7/18/19, 7/23/19 for unspecified pain (resident cannot communicate much to clarify pain), unscheduled doctor visit 7/25/19 with diagnosis of shingles
Soreness on injection site for a few days, then pain down on arm, difficulty twisting or lifting of arm. After a few months, pain now moved to back of neck and shoulder area. Not seen by MD.
receives a vaccine one day after it's expired; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receives a vaccine one day after it's expired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (receives a vaccine one day after it's expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receives a vaccine one day after it's expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information is provided bythe reporter No treatment information provided.   Reporter did not allow further contact
Patient already received a flu shot this season. Patient was wanting to received the latest moderna shot ( spikevax), but the flu shot was incorrectly billed and administered.
CHIEF COMPLAINT:   Pt reports gets dizzy and lightheaded when he gets up.  was just released from hospital after rehab and could not aford perscriptions   HISTORY OF PRESENT ILLNESS:     68-year-old male past medical history of diabetes, hyperlipidemia, osteoarthritis presenting the hospital due to dizziness and lightheadedness.  He was recently released from his nursing facility when she signed out from a few days ago and has been living with his daughter.  He reports that it has been difficult living with his daughter and that he is not getting the care that he needs and would like to go back to his nursing facility.  He does admit to giving himself too much insulin earlier today and was noted to be hyperglycemic to the 40s in the emergency room.  He has had difficulty administering his medications.  He denies any chest pain, shortness of breath, nausea/vomiting/diarrhea, fevers/chills.  Just finished receiving both doses of Covid vaccine with his second dose 1 week ago.  According to daughter who along with her husband are the primary caregivers of the patient patient was recently discharged from his nursing facility and has been living with her and was having issues with his finances due to the transition from the nursing facility.  She would prefer the patient come back home as she is concerned that it might mess up his financial situation again and he she feels that he gets better care at home as he has 24-hour aides between her and her husband.  She did note that earlier today she had left his insulin time at his normal dose and when she returned after briefly leaving the home he had administered himself insulin and had given himself approximately 5 units more than his regular doses.  He has been mostly homebound only interacting with his daughter and grandchildren.  In the ER, is afebrile stable vital signs.  Lab work is notable for hypoglycemia to 45.  His glucose returned to 105 after administration of p.o. orange juice.  His Covid swab returned positive
had a sl sore throat 18 & 19OCT p/vax devel cold w/cough & sinus infect like never a/;pt thinks should be asked not only if they have a fever but also if they might be coming down w/something a/vax
Information has been received from a pharmacist concerning her 12 month old son with no past medical history and no known drug allergies who on 18 OCT 2001 was vaccinated SQ in the thigh with haemophilus b conjugate vaccine. It was noted that she "thinks" it was PEDVAX HIB". Concomitant therapy included a dose of SQ in the thigh of diphtheria toxoid/pertssis vaccine, teta (manufacturer unknown). It was reported that both these injections should have been given IM. "Later" the patient experienced a 1.5 to 2 inch diameter red hard area that was displaced off center from the injection site. Unspecified medical attention was sought. Additional information has been requested.
pt devel severe local rxn p/vax;this is one of three pt's from this site who exp the above rxn;adverse event may have been previously reported to the FDA by the reported;
report side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report side effects). At the time of the report, VACCINATION COMPLICATION (report side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
SWOLLEN ARM AND PAIN THAT RADIATES AROUND INJECTION SITE AND DOWN PATIENT ARM
Redness; Swelling; Reaction on the posterior deltoid area; Itching; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04044) with additional document received on the same day (being processed together) form other non-health professional via Med Communications (reference number: SEQW20-04036) and concerned a patient of unknown age and gender.   The patient had no relevant medical history and was not taking any concomitant medications.    On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for flu prevention. The batch number reported was 283847, expiry date: 30-Jun-2021.    On the same date, the patient experienced redness, swelling, itching, and a reaction on the deltoid posterior area.  On an unknown date in Oct-2020, the patient was admitted to the hospital due to the events. The patient was treated with clindamycin intramuscularly, dexamethasone intramuscularly and Benadryl (diphenhydramine hydrochloride).   At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the events and was still hospitalized.   The reporter assessed the case as serious due to hospitalization.   This case is linked to cases 202005385, 202005362 and 202005363 (the same reporter).  Company comment:The patient developed erythema, swelling, adverse reaction (reported as "reaction on the deltoid posterior area") and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed erythema, swelling, adverse reaction (reported as "reaction on the deltoid posterior area") and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
dyspnea, and worsening lower extremity edema beginning next day, CHF on xray, admitted to hospital.
Granuloma; Two rim circle bumps on my chin and one underneath my eye; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA (Granuloma) and PAPULE (Two rim circle bumps on my chin and one underneath my eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HYALURONIC ACID (RESTYLANE) for an unknown indication.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced GRANULOMA (Granuloma) and PAPULE (Two rim circle bumps on my chin and one underneath my eye). At the time of the report, GRANULOMA (Granuloma) and PAPULE (Two rim circle bumps on my chin and one underneath my eye) outcome was unknown.            No concomitant medication reported. No treatment medication or therapy reported.
Fever, severe rash, inflamed right nipple, red at injection site, running nose, disoriented, constant crying.
Injection site warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to the touch) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to the touch) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Shingles flare starting 2 days post immunization to right neck, pain and soreness started next day but patient thought it was tenderness of lymph nodes due to immunization and typical muscle soreness from sleeping wrong.
This case was reported by a pharmacist via sales rep and described the occurrence of painful rash in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced painful rash and shingles. On an unknown date, the outcome of the painful rash and shingles were recovering/resolving. It was unknown if the reporter considered the painful rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, during the first week of June, a patient received the 1st dose of SHINGRIX. Pharmacist reported that early last week from the reporting date, the patient experienced a small painful rash on the back of her arm that looked like a small case of shingles. On the reporting date, the patient came back into the pharmacy and the rash looked better and it was not as painful. The pharmacist reported that the patient had not been to the doctor. The sales representative had limited information regarding this event.
Chills, fever, headache, couldn't feel legs after second dose  8 weeks later: hair falling out, cysts on liver and kidney, cyst on scalp  10 weeks later: large bruising over injection site.
first vaccine  dose on Jan 28 2021 noticed hearing loss on Jan 30 2021. Contacted primary MD on Feb 21 2021, started on antihistamines and decongestants per his recommendation. No improvement over the next few weeks. Seen by ENT and had audiology test on 4/19 /2021. Results: no structural damage but substantial low range hearing loss in Left ear. Received steroid injection in left ear and began 2 week course oral steroids. Follow up in 1 week and will receive addition steroid injection.
Within 9 hours of receiving shot,  fever rose from 101.1 to 104.2 by 3am.  Night sweats, severe chills, intense pounding headache, body aches.  Slept 21 of the next 24 hours. Next day fever dropped to 102.7.  Right now, 50.5 hours after shot, fever stands still 102.0°
Severe migraine, chills, fever, nausea, vomiting lasting 2 days. 11/16/09 Medical records received for date 10/23/09 to 10/27/09. OB record. Pt received vax at OB visit on 10/23/09. Pt. called 10/27/09 MD stated "got really sick" vision loss, felt flush, delusional, nausea, HA.
Approx 5  hours after injection:  Fatigue, Injection site soreness Approx 16 hours after injection:  Fatigue, Injection site soreness, Headache Approx 21 hours after injection: Fatigue, Injection site soreness, Fever, Nausea Approx 3 days after injection: Fatigue, Injection site soreness, Fever, Nausea, Rash  & discoloration at injection site, swollen thigh down to the knee. Approx 4 days after injection:  Fatigue, Injection site soreness, Nausea, Rash  & discoloration at injection site, swollen thigh down to the knee,  Left Face Numbness (Lasted about 7 hours) Approx 5 days after injection: Fatigue, Injection site soreness, Nausea, Rash  & discoloration at injection site, swollen thigh down to the knee, Thigh muscle extremely tight. 6 days after injection I began to feel better and felt normal by Tuesday...a full week after receiving vaccine.
PATIENT FOR PHYSICAL EXAM AND SHOT VACCINE ( NEVER HAD IT  BEFORE EXCEPT HEP B AT BIRTH) VACCINES GIVEN AROUND 11:30 AM, IBUPROFEN ORAL SUSPENSION 100MG PER 5ML AGES 2 TO 11 YEARS 4 FL OZ (118 ML) BOTTLE ( 0.75 ML GIVEN TO PATIENT AFTER SHOT) , LEFT OFFICE AFTERWARDS, WENT TO DONUT SHOP AT 12:00, HE ATE 4 DONUT HOLES GLAZED.. HE ALSO ATE GREEN DUM DUM LOLLIPOP AFTER THE SHOT AND DRANK CHOCOLATE MILK WITH DONUT. HOME BY ABOUT 2 PM  + RASH, HIVES. SEEN BACK 3:30 PM  BENADRYL 10ML GIVEN AT OUR OFFICE
onset left arm swelling, red, hot to touch, itchy. 12cm w by 8.5 cm length starting 8 days post injection.
administered Infanrix instead of Boostrix; 11y/o was administered Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: The medical assistant reported that 11 year old patient was administered Infanrix instead of Boostrix. The reporter consented to follow up. Additional Supportive Information: As the 11 year old patient was administered Infanrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The case has been linked with the case US2022088501 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088501:Same reporter
12/11/2021 Vaccination 04/1/2022 Doing a normal breast exam, I noticed a lump under my right arm. I contacted Dr.She saw me the following week.  04/26/2022 Mammogram; dense breast tissue  04/26/2022 Sonogram; dense breast tissue  *stated it could be related to the vaccine.  **no further medical treatment at this time.
aggravating his COPD; aggravating his COPD; rash on his torso, arm and the back of his shoulders; felt the need to urinate but could not, , he had a burning feeling; prostate stated giving trouble; bronchial problems; muscle weakness; stomach is queasy; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 73 years old male patient who experienced aggravating his COPD (Chronic obstructive pulmonary disease), rash on his torso, arm and the back of his shoulders (rash), muscle weakness (Muscular weakness), felt the need to urinate but could not, had a burning feeling (Dysuria), stomach is queasy (nausea) and prostate stated giving trouble (Prostatic disorder NOS), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious aggravating his COPD (chronic obstructive pulmonary disease), rash on his torso, arm and the back of his shoulders (rash), muscle weakness (muscular weakness), felt the need to urinate but could not, he had a burning feeling (dysuria), stomach is queasy (nausea), prostate stated giving trouble (Prostatic disorder NOS) and bronchial problems (bronchial disorder) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was Chronic obstructive pulmonary disease, rash, Muscular weakness, Dysuria, nausea and Prostatic disorder NOS.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Rash below site of inj & above it 3 to 4 cm, eryth, no abscess.
Received flu vaccine on 11-13-08 and now has bullous @ site - non tender, or red, clear fluid - C and S just for precaution - no result yet.
Fever, congestion. Patient went to walk-in clinic and they sent her straight to emergency room. Treated with unknown meds in ER, given Zpak and Albuterol rx.
I contracted COVID-19 on 5/3/2022 with symptoms of cough, congestion, fever, chills, rashes, ear ringing, myalgia, extreme fatigue, chest tightness, shortness of breath, loss of smell and taste, abdominal pain, severe headache, and light sensitivity. I was prescribed Guaiatussin Apfy, and began taking it on 5/8/2022. I have been using my Neti Pot once daily and Fluticasone. My symptoms have not resolved as of yet.  I experienced Deep Vein Thrombosis and swelling/pain in my arm and leg above the knee since my Dose 4 of the Vaccine and it has not resolved.
I had low-grade, fever, headache, coughing, sore throat, body ache, lost of taste and smell. These lasted for about 10 days. On Jan 11th, I tested positive for COVID-19. I had a CT scan, shows that I have paralyzed voice cords.
This spontaneous report was received from a medical assistant and refers to a 20 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-JUL-2016 and on 13-APR-2017, the patient was vaccinated with a pediatric dose of VAQTA (lot # and expiration date were not reported) intramuscularly for prophylaxis.  There were no known adverse effects.  Additional information has been requested.
severe chills, body shook and would not stop for about 2 hours; stomach hurt; This is a spontaneous report from a contactable Other Healthcare Professional (HCP, patient).  This 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH 9899), on Dec2020 (provided both as 19Dec2020 and 129Dec2020) at 10:00 PM at single dose, and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL 3248), on 09Jan2021 at 11:00 PM at single dose ,both for COVID-19 immunisation and via an unspecified route of administration. Age at vaccination was 36-years-old. Vaccine location was left arm for both doses. No other vaccine was received in four weeks. Medical history and concomitant medications were none. The patient had severe chills that started about 12 hours after the first vaccine (as reported). Her body shook and would not stop for about 2 hours. However onset was also reported as 09Jan2021 at 10:00PM (to be clarified). Treatment included Pepto bismol because her stomach hurt and she had ''dia'' (as reported). Outcome was recovering.
Left leg swelling and redness and slightly warm, continue Tylenol and Benadryl.
I did NOT have a single headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "I did NOT have a single headache".  Additional information: It was stated that the patient suffered from migraines, its been a 10 year struggle, The Patient received first shot of the vaccine in March and as the patient expected, had a horrific migraine and nausea for 5 days suffice to say, patient was really nervous to receive the second shot but did so April 1st expecting the worst however the patient did not have any symptoms! The patient normally get 6-10 migraines a month and of course take medicine etc. but the patient wanted to let someone know that for a month patient did not have a single headache. The patient requested to look into this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021530507 same patient/drug, different dose/event.
Pt with no previous history of needing ALBUTEROL.  Mother thinks he may have wheezed in past with URI'S.  Started wheezing night of FLUMIST and req'd ALBUTEROL and ORAPRED x5d.