chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was experiencing severe shoulder pain; Face was also really swollen; Both of her eyes are swollen shut; She states that vaccine did not gone into the muscle; Initial information regarding an unsolicited valid non serious case was received from a Consumer/Non-HCP (Healthcare professional) via The Agency (Reference number- 00355124) and transmitted to Sanofi on 11-NOV-2020.  This case involves a female patient (unknown demography) who experienced severe shoulder pain (arthralgia), face was also really swollen (swelling face) and both of her eyes are swollen shut (eye swelling), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. She also states that it did not go into the muscle (wrong technique in product usage process).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non serious severe shoulder pain (arthralgia), 24 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patients face was also really swollen (swelling face), both of her eyes were swollen shut (eye swelling), 24 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient reported that the vaccine did not go into the muscle.  This was also a case of actual medication error due to wrong injection technique (latency: same day).  It was not reported if the patient received any corrective treatment or not.  The outcome of the events arthralgia, swelling face and eye swelling were 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 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.  Batch number has been requested for suspect product for this case.
A non-serious spontaneous report of sore throat and headache has been received from a consumer, concerning an 11-year-old female, subsequent to H1N1. The patient's past medical history and concomitant medications were not reported. The patient received H1N1 on 24-Oct-2009 through a company's employee immunization event. On 27-Oct-2009, the patient developed sore throat and headache. The outcome of the adverse events was not reported.
At cheerleading practice; sudden onset right thigh tingling, quickly progressed to numbness and weakness in both legs; by the time mother arrived to pick her up, she was unable to bear weight and both legs were numb.  Became bladder and bowel incontinent.  Current Working diagnosis is Transverse Myelitis.  Receiving High Dose Steroids.  No response to therapy yet.
Diagnosed with right upper arm DVT.  Extensive DVT from right clavicle to elbow via ultrasound, diagnosed with potential venous thoracic outlet syndrome, but MRI has not been completed. Started on Xarelto 20 mg daily.  Right arm swelling, discoloration.
Patient was standing from chair in observation area to be checked out and upon standing stated was dizzy.  He stated a  spinning feeling, like coming from inner ear. I had him sit in chair for 15 more minutes in front of me and he started to feel better. We then moved him to chair in observation chair for 10 minutes and he stated feeling better. He then went home
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 30-MAY-2017, the patient was vaccinated with a single dose of VAQTA injection (intramuscularly; lot # M034893), that had expired on 26-MAY-2017. No adverse effects were reported. Additional information is not expected, as there was no consent to contact the reporter.
Had a very bad migraine all day and night. Extremely Exhausted and had some chills took Tylenol for headache which did not help.  Slept most of the day and night. Next day was absolutely fine feeling like myself
fever; chills; the pain went through the underarm; she got the first dose of the Pfizer Covid-19 Vaccine on 16Apr2021/getting her 2nd dose of the vaccine on 03May2021; very serious pain in right breast; This is a spontaneous report received from a contactable consumer or other non-health professional (patient).  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch no: not reported/Lot Number: EW0172) via an unspecified route, administered in left arm on 03May2021 (Age at vaccination 75 years) as dose 2, single for covid-19 immunization. Medical history included ongoing diabetes mellitus since unspecified start date and concomitant medications reported as none. Historical vaccine included patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158) via an unspecified route of administration, administered in left arm on 16Apr2021 (Age at vaccination 75 years) as dose 1, single for covid-19 immunization with no adverse events. The patient got the first dose of the Pfizer covid-19 vaccine on 16Apr2021, and 2nd dose on 03may2021 with inappropriate schedule of product administration. After the second shot, on 03May2021 patient experienced with very serious pain in right breast that she had not had before which was started that evening. Reported as her breast pain was severe and that the pain went through the underarm. She got the shot on the left side but was having the problems in her right side. On an unspecified date she experienced fever and chills a day after the 2nd dose but went away a day after when her daughter gave her tea. Her daughter had her mammogram and was telling her doctor about it. Her doctor asked if the pain started from her back. Doctor told her daughter that it was from the Covid shot. Patient wanted to know how long it last or will it wear itself out. On 01Mar2021, the patient underwent lab tests and procedures which included blood work with unknown results done before got Covid shot. Treatment was reported as none. Outcome of the events chills and pyrexia was recovered on an unknown date in 2021, Breast pain and pain went through the underarm was recovering.  Follow-up attempts completed. No further information expected.
The patient did not have a fever. The area of injection, left leg, was swollen and tender. Treatment given was a cold compress.
Injection site red, warm. Lt upper arm diffuse swelling radiating to Lt chest. Significant painful Lt axillary lymphadenpathy. Diffuse painful adenopathy throughout the body (base of skull, neck, groin, Rt axilla). Discomfort peaked evening of 1/5/22.
Site: Bruising at Injection Site-Medium, Additional Details: left arm few days purple rash circular, not raised . Next week wrist upto shoulder no itching no pain
COUGHING; ALWAYS GOT INFECTIONS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. 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 coughing, and always got infections. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coughing and always got infections was not reported. This report was non-serious. This parent/child case is linked to 20220251231.
Information has been received from a physician concerning a 21-year-old female with asthma, and allergies to pollen, cats, mold, and dogs, and with a history of heat rash who on 25-May-2006 was vaccinated SC in the left arm with an 0.5 ml dose of measles virus vaccine live (lot#652338/085R). There was no illness at the time of vaccination. Concomitant therapy included vitamins (unspecified) and Zyrtec. On 27-May-2006, the day after vaccination, the patient experienced a transient rash below the injection site of the left arm and patch of redness on other arm and leg. Subsequently, the patient recovered. No treatment was noted. No lab diagnostic studies were performed. There was no product quality complaint. Follow up information received from a physician indicated that a macular rash developed on the left arm below the injection site. The patient recovered on 28-May-2006. Unspecified medical attention was sought. There were no relevant diagnostic tests of laboratory data. No additional information is expected.
Pt inadvertently was given Hep A 1 mL adult dose.  Called CDC, informed no adverse reaction other than redness to site.
DX: COVID, SOB and COPD, pt admitted with COVID pneumonia.  Completed remdeivir and discharged to skilled nursing facility.
Chills, body aches, fever, fatigue, nausea sore arm Tylenol, Ibuprofen, fluids, rest. Lasting 2 days, slight improvement day 2
Focal redness, swelling and itching improved after 10 min with below treatment. Ice pack applied to area. 5mL's of BENADRYL given.
lyophilized vaccine vial of Acthib reconstituted with Sterile water instead of single/no AE; Initial information received on 24-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 months old male patient who received lyophilized vaccine vial ofHIB (PRP/T) VACCINE [ACT-HIB] reconstituted with sterile water instead of single.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 22-Apr-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI904AA via unknown route in the left thigh.  It was of actual medication error due to  Inappropriate reconstitution technique .  No adverse event was experienced..  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.
Immunizations 5/21/10. 5/23 (R) leg red swollen, No fever; seen in office 5/24/10 area of erythema LAT sl warm and tender treated with oral KEFLEX-instructed to use if it did not clear, but cleared without abx.
Couple fingers were in pain; Had trouble opening back up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Couple fingers were in pain) and JOINT RANGE OF MOTION DECREASED (Had trouble opening back up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Couple fingers were in pain) and JOINT RANGE OF MOTION DECREASED (Had trouble opening back up). At the time of the report, PAIN IN EXTREMITY (Couple fingers were in pain) and JOINT RANGE OF MOTION DECREASED (Had trouble opening back up) outcome was unknown.            Concomitant medication was not reported.  The patient thought she had a reaction to the COVID vacation where a couple fingers were in pain and had trouble opening back up. Patient agrees to have physician contacted.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Flu shot at 1400 hrs at VA on Fri 10/17/08 same day at appx. 2200 hrs had a violent reaction. Fever, cold, shakes, etc. Lasted until late Sunday 10/19/08. Arm swollen, red itching for another 3 days.
Had wave after waves of nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 24Mar2021 13:00 (Lot number: ER8733) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "Had wave after waves of nausea". Therapeutic measures were not taken as a result of nausea.  Additional information: She wanted to know if this was a normal reaction. Caller stated her kids were scheduling their shots too now and wanted to know if there were any bad reactions, or like 3,500 deaths reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines was administered on same date of the Pfizer suspect. No adverse event requires a visit to emergency room and physician Office. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. She was not aware of about family medical history relevant to AE(s). No relevant test performed.   No follow-up attempts are possible. No further information is expected.
Really tired achie; Joints ached very bad; very tired; had chills; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), intramuscular, administered in Left arm on 17Feb2021 10:40 as dose 2, single for COVID-19 immunisation. Medical history included Type 2 Diabetes and Cholesterol. Concomitant medications included ongoing lisinopril; choline fenofibrate (TRILIPIX); metformin, all for type 2 diabetes and cholesterol; magnesium chloride (SLOW-MAG); multivitamins and alene, all for an unspecified indication. Patient had no prior vaccinations. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) , Intramuscular, in left arm, on 21Jan2021 10:40, as single dose for COVID-19 immunization and on 05Feb2021, the patient experienced night sweats, shortness of breath, tired more so than usual. On 17Feb2021 20:00, the patient experienced very tired and had chills and on 18Feb2021 18:00, she was really tired, achie and  joints ached very bad. Therapeutic measures were taken in response to the events included, Tylenol. It was reported that she seemed okay in the morning. The outcome of the event had chills was unknown and of other events was recovering.  No follow-up attempts are needed. No further information is expected.
Allergic reaction within 1/2 hour, post vax, had swelling of arm where shot was given; 8" X 5" around and 2 1/2" high, welt within this area, itching (severe), discoloration of skin on arm, headache and fever for 36 hours. Doctor examined arm and prescribed liquid Benadryl. Swelling of arm lasted 1 week and itching also.
Product quality issue; Pharmaceutical product complaint; Finger knick; inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of cut wound in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) and (batch number T2472, expiry date 23rd January 2022) for prophylaxis. This case was associated with a product complaint.   On 9th August 2019, the patient received Shingrix. On 9th August 2019, the dose was an unknown dose. On 9th August 2019, immediately after receiving Shingrix, the patient experienced cut wound, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the patient experienced product quality issue and pharmaceutical product complaint. On an unknown date, the outcome of the cut wound, inadvertent exposure to vaccine, exposure via skin contact, product quality issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the cut wound to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist was an experienced user. The pharmacist stated that she did not observe any defect but while she was drawing out the Shingrix adjuvant, with the syringe in her right hand and the adjuvant vial in her left hand, and inverting the adjuvant upside down to draw the content out, she got a knick on her left forefinger which was gloved and did bleed. The pharmacist had to discard the adjuvant because she felt it had contaminated the vaccine surface.  The pharmacist stated that she thought that she knicked her finger on the red ring of the adjuvant vial. The vaccine was not administered.  The pharmacist had taken a picture and would be emailing. The pharmacist had discarded the adjuvant vial and thus the defective product will be not be sent to Glaxosmithkline. The Glaxosmithkline tp process credit for one dose of the Shingrix vaccine. The pharmacist has not provided the Glaxosmithkline direct account no. The reporter reported that stated there appeared to be a small raised or sharp area on the metal ring, just enough to cause her finger to bleed. The reporter said that she sent a photo to our group mailbox, but had not received it by the time the reporter spoke to her and confirmed she had the correct email address and she said she would resend the photo. At the time the reporter was typing this email, and still had not received the photo. The reporter said it was hard to see the raised area in the photo and confirmed the sample was thrown away. The metallic skirt of the vial of adjuvant was broken during the preparation of the vaccine and hurt the pharmacist. The metallic skirt already damaged in the box or when taking the flip off away from the skirt The pharmacist would call back to provide this information. The reporter did not consent to follow-up.
tested positive for Covid; This is a spontaneous report from a contactable consumer (patient mother). A 24-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Apr2021 (at the age of 24-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first covid vaccine dose on Friday, 02Apr2021. Afterwards he went out to celebrate that he got the shot, and on Tuesday, 13Apr2021 he tested positive for covid. The patient was currently on isolation. They wanted to know, if after the first shot if you contract covid how long you should wait until you get the second shot. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administered 6/25/14: On 6/26/14 pt experience severe malaise, tenderness at injection site, face was flushed. 6/27/14 pt presented to the office with a rash below the injection site w/erythema. Pt given KEFLEX 1 QID x 7 days.
Information has been received from a registered nurse concerning a 9 year old male who on 24-MAR-2009 was vaccinated SC with VARIVAX (Merck) (lot # 662459/1784X) into the right arm.  On 25-MAR-2009 the patient developed large red, swollen area at injection site and tenderness in right axilla.  The patient was examined on 27-MAR-2009 but symptoms were resolving without treatment.  It was unspecified if the patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 50-year-old patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: unknown) dose was not reported, 1 total, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-JUL-2021, the patient developed nasal congestion, coughing and fever. He went and took a Covid-19 polymerase chain reaction (PCR) test on July 15th which came back positive for covid-19 infection on July 16th, hence he experienced confirmed covid-19 infection and confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186348.; Sender's Comments: V0-20210739108-Covid 19 Vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS