chrisvoncsefalvay/vaers-outcomes huggingface dataset:
small grey spot at the injection sites that are not fading or going away; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site discoloration in a 1-year-old male patient who received DTPa (Infanrix) (batch number 9R2D7) for prophylaxis.   Co-suspect products included Hib (Hiberix) (batch number 7F257) for prophylaxis and MMR (Priorix) (batch number 75593) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (received on 27th May 2022, for tolerance of Pediarix, refer case US2022AMR149561) and Hiberix with an associated reaction of skin discolouration (received on 27th May 2022, for tolerance of Hiberix, refer case US2022AMR149561).   On 30-JUN-2023, the patient received Infanrix .5 ml, Hiberix .5 ml and Priorix .5 ml. On an unknown date, an unknown time after receiving Infanrix, Hiberix and Priorix, the patient experienced injection site discoloration (Verbatim: small grey spot at the injection sites that are not fading or going away). The outcome of the injection site discoloration was not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Infanrix, Infanrix Pre-Filled Syringe Device, Hiberix, Priorix and Priorix Pre-Filled Syringe Device.   It was unknown if the company considered the injection site discoloration to be related to Infanrix, Infanrix Pre-Filled Syringe Device, Hiberix, Priorix and Priorix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:US2022AMR149561   Additional Information: GSK Receipt Date: 13-JUL-2023 The Infanrix, Hiberix and Priorix vaccines were leaving a small grey spot at the injection sites that were not fading or going away.  This patient had multiple spots while their sibling had zero. The reporter agreed to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR149561:Same patient/diffrent vaccine
The patient indicated that this was her 3rd dose after receiving her 2nd dose from us..
Mom of the client, called the clinic and shared that patient developed a 102 fever last evening, and has been able to keep it to 99/100 F with Tylenol. She also has a nickel size reddened area over injection site on the right thigh (where the DTap/IPV/Hib/HebB was given). She has increased fussiness, but has been drinking fine, and continues to have wet diapers.
PAIN, REDNESS AT SITE OF INJECTION, HEADACHE, MUSCLE ACHES, FEVER, FATIGUE
Pt. received Hep B vaccine on 02Aug14 at 1430 in (L) arm. After administrating vaccine, a hematoma appeared within seconds. 1 minute later pt, stated "feeling dizzy." Applied ice on injection site and had pt. sit down.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadedness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 10 minutes after administration patient started flushing effect and cold feet and hands. Dizzy and reported to the RPH. Made him sit with head down for few minutes, patient is diabetic and checked his blood glucose with continuous monitor and it was okay.
Seven year old female at library to take her 2nd peds Pfizer vaccine.  She was very apprehensive and anxious.  Mother was with patient and requested nurse use "Shot Blocker" device to distract patient from vaccine shot.  Nurse gave vaccine while mother held the shot blocker in place on Right upper arm.  Patient did well with actual injection, but as she got up out of chair  quickly, she fainted and fell onto the floor, hitting her head on the carpeted floor,  Nurse evaluated patient and checked her pulse-strong and steady at 88bpm.  Face was pale, respirations steady, within 15-30 seconds, pt had her eyes open and was responding to questions okay.
Rash over body & some swelling face; Seen by MD; Returned to ER had swelling of hands & feet & rash; rash fades & returns when gets hot or cries;
Patient has swelling and edema in the area of the administration. Area has been increasingly getting larger and moving down the arm. Cautioned patient about cellulitis (it is not warm to the touch or red but definitely extremely swollen) and recommended she go to MD. She was going to go after we spoke.
Redness at the injection site; Swelling at the injection site; Hardness at the injection site; Tenderness at the injection site; Light rash at the injection site; A spontaneous report  was received from a consumer concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine site erythema, vaccine site swelling, vaccine site induration, vaccine site pain and vaccine site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 6-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the left arm for prophylaxis of COVID-19 infection.  On 6-Jan-2021, the patient experienced vaccine site erythema, vaccine site swelling, vaccine site induration, vaccine site pain and vaccine site rash.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events (vaccine site erythema, vaccine site swelling, vaccine site induration, vaccine site pain and vaccine site rash) was ongoing.
Patient woke up with small red bumps starting from her torso and going up her body. Right arm was slightly itchy at the bend. Red bumps  were not hot to the touch. Upon follow up with the patient two hours later she was feeling better, the rash was subsiding. She did not take BENADRYL as advised.
A 49 years old patient received a dose of FLUZONE HIGH-DOSE QUADRIVALENT/ No AE; A 49 years old patient received a dose of FLUZONE HIGH-DOSE QUADRIVALENT/ No AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via regulatory authority: 00812423.   This case is linked to cases 2021SA343492, 2021SA343828 and 2021SA343988 (same reporter).  This case involves a 49 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   No concomitant vaccines given to patient.  On 13-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ769AC, expiry date: 30-Jun-2022, frequency/ drug interval dosage: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events).  It was reported "Caller reported last night a family of four who are all under the age of 65 were giving the FLUZONE HIGH DOSE VACCINE. Caller reported there are no adverse events at this time but wanted to make sure there was nothing to expect and what they should do from here."  Emergency room/ Doctor visit on 13-Oct-2021. Product used: Used and Still using product: No.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever of 101 (normally run about 97), extreme chills and painful body aches, skin tender to touch, injection location hot to touch, lymph nodes under chin all inflamed and extreme swelling of left side of face in jaw area and in neck, slight swelling of tongue and ?cotton mouth? feeling.
due to the infection in her tooth she is taking penicillin. She wanted to know will that make the vaccine less effective; This is a spontaneous report from a contactable consumer(Patient). A 76 years female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that she is scheduled for the second dose of the Pfizer covid vaccine on Monday, but due to the infection in her tooth she is taking penicillin. She wanted to know will that make the vaccine less effective. The caller wanted to know if she can take Tylenol after the second dose if she experiences any side effects. Therapeutic measures were taken as a result of due to the infection in her tooth she is taking penicillin. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old male patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). This case was associated with a product complaint. On 1st June 2015, the patient received KINRIX (intramuscular) .5 ml. On 1st June 2015, less than a day after receiving KINRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the injection site erythema, injection site warmth and product complaint were unknown. The reporter considered the injection site erythema and injection site warmth to be possibly related to KINRIX. It was unknown if the reporter considered the product complaint to be related to KINRIX. Additional information received: There were also 2 other patients who experienced the same side effects. Nurse had 7 more prefilled syringes left on the box and she preferred to have a different box to replace the one she already had as she is concerned about using the remaining prefilled syringes. Nurse is sending the product back to the company. Company is replacing product for the physician's office.
Muscle and joint pain, mostly in upper body, that started about one week after injection. Treating with ibuprofen and massage. Symptoms still present but not worsening.
Tinnitus started about 2 weeks after vaccine and is ongoing. Mild dizziness as well.
ACUTE ONSET SEVERE B/L LEG AND LOWER LEG PAIN STARTED 2 DAYS AFTER VACCINE ADMINISTRATION
area around injection site firmer; Tired, wanted to be held; legs limp and flaccid/Flaccid leg muscles; legs limp and flaccid/Flaccid leg muscles; would not stand up or walk; 23 month old, received 4th dose; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 23-month-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTP IPV HIB (received other pentacle vaccine).   On 22nd February 2022 10:15, the patient received the 4th dose of Infanrix (intramuscular). On 22nd February 2022, the patient started Infanrix Pre-Filled Syringe Device. On 22nd February 2022, less than a day after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced injection site induration, tiredness, flaccidity muscle, limping, gait inability and inappropriate age at vaccine administration. On 23rd February 2022, the outcome of the flaccidity muscle, limping and gait inability were recovered/resolved. On an unknown date, the outcome of the injection site induration, tiredness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site induration, tiredness, flaccidity muscle, limping and gait inability to be related to Infanrix and Infanrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical doctor.   The patient received 3 other pentacle vaccine prior to receiving Infanrix. The patient received Infanrix in left anterior leg.  He had no other vaccines on this day.   The doctor stated that, the patient was tired after he got home after his vaccination, and he wanted to be held, so his mother held him for a long time.  When his mother put him down, she noticed that, there was no spontaneous movement in either of his legs, they were limp and flaccid.   The patient would not stand up or walk.   There was no swelling at the injection site, but the area around the injection site was firmer.   EMS was called around 5 pm.   After much effort, the EMS team was able to get the child to bear weight on his legs, but he would not walk. The next evening, the doctor had a video conference with his mother, and the symptoms had resolved. The patient was able to lift his legs and walk. The reporter consented to follow up.
extremely itchy palms/extremely itchy bottoms of our feet; Pretty exhausted/Worn out/tried the other day; unable to actually walk my dogs around the block because I am so worn out; Couldn't even finish the walk; Off and on shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "extremely itchy palms/extremely itchy bottoms of our feet"; FATIGUE (non-serious), outcome "unknown", described as "Pretty exhausted/Worn out/tried the other day"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "unable to actually walk my dogs around the block because I am so worn out"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Couldn't even finish the walk"; DYSPNOEA (non-serious), outcome "unknown", described as "Off and on shortness of breath".  Additional information: Consumer stated, her husband and patient both got the Pfizer Bivalent Shot (Clarified as: COVID-19 Vaccine Bivalent). They got that on Wednesday and both of them ended up within 24 hours, of extremely itchy palms and extremely itchy bottoms of their feet, last for couple of hours, kind of weird, never had that before. They are both pretty exhausted and this was now Sunday, patient had been unable to actually walk her dogs around the block because she so worn out. She tried the other day and she couldn't even yesterday and she couldn't even finish the walk barely and she had off and on shortness of breath and she do not know how long these side effects are going to last, But this was the fourth day now, the third day actually. They had the shot (COVID-19 Vaccine Bivalent) on Wednesday. So, she just a little concerned. Consumer stated, her husband had the same effects. Consumer was informed about the Role of Pfizer Drug Safety. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling sensation throughout the body, cold feet, nausea, dizziness, headache. Also inflammation, redness and pain in right arm (where shot was given). All symptoms persisted for three days. In the two weeks after the shot the nausea has been coming and going, but all of the other symptoms are gone.
pt recv vax 24AUG98 & started having h/a, chills & fever 25AUG98 @ 10AM;sx cont;referred to MD;ER checked pt throat prescribed ATB on 26AUG98;27AUG98 pt states does not feel well;
cold sores around mouth; blisters on lower corners of the mouth,blisters around mouth; blisters in each corner of the mouth and are a little painful; itchy blisters; slight soreness of the muscle; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sores around mouth), BLISTER (blisters on lower corners of the mouth,blisters around mouth), ORAL PAIN (blisters in each corner of the mouth and are a little painful), PRURITUS (itchy blisters) and MYALGIA (slight soreness of the muscle) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     No medical history reported.  Concomitant products included HYDROCORTISONE for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sores around mouth), BLISTER (blisters on lower corners of the mouth,blisters around mouth), ORAL PAIN (blisters in each corner of the mouth and are a little painful), PRURITUS (itchy blisters) and MYALGIA (slight soreness of the muscle). The patient was treated with HYDROCORTISONE for Swelling and Itching, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sores around mouth), BLISTER (blisters on lower corners of the mouth,blisters around mouth), ORAL PAIN (blisters in each corner of the mouth and are a little painful), PRURITUS (itchy blisters) and MYALGIA (slight soreness of the muscle) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Rash  Narrative:  employee states: she experienced 2 seperate reactions. The first reaction was on the day of injection: small rash across chest, around 10 pinpoint red dots, not noticed until that evening. She took some diphenhydramine and the rash was gone in the morning. On day 10 (1/10/2021) she noticed an "apple-sized" rash below the injection site and a "thumbprint-sized" rash below that. Again took diphenhydramine and the rash mostly resolved by morning.
Got sick for a week; Rashes all over her body; Itching for more than 24 hours; Wakes her up at night; This is a spontaneous report from a non-contactable consumer(patient). A 76-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient had a serious reaction after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. The patient got sick for a week. Another 2 weeks have passed, and now patient has rashes all over her body, and patient has been itching for more than 24 hours. The patient said the itchiness wakes her up at night and it is so bad. The patient said her symptoms lasted 3 weeks and that she currently still has them. The patient already went to the doctor twice, and was prescribed with Prednisone for 2 weeks. The medication did nothing. The outcome of events was not recovered.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist referring to a 61 year old male patient. The patient had no pertinent medical history, neither drug reaction/allergies. On 29-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N020502, expiring on 08-FEB-2019 intramuscularly in an unspecified location no in deltoid (strength, dosage schedule and indication were not provided). There were no concomitant medications. On 29-NOV-2017, the patient experienced injection site swelling and injection site erythema which began after the injection. No lab tests were performed. On 30-NOV-2017, the patient returned to the pharmacy seeking for medical attention. The patient was scheduled for return to the pharmacy on 01-DEC-2017 to follow up on recovery. The outcome of injection site swelling and injection site erythema was reported as recovering. The causal relationship between PNEUMOVAX 23 and the aforementioned events, was not reported.
Physician Discharge Summary    Age: 48 y.o. Birthday:  1/6/1974 Admit Date: 7/10/2022  8:22 PM Discharge Date:       Admit Date:  7/10/2022 Discharge Date:  7/12/2022    Discharge Diagnosis: Principal Problem:   Ureteral stone with hydronephrosis Active Problems:   HTN (hypertension)       HPI: 48 y.o. female with PMH of GERD and HTN, prior kidney stones, who presented from for persistent flank pain. CT there with right sided ureteral stone and some hydronephrosis. Pain unable to be controlled as outpatient and returned to ER prompting transfer for urology services. No cp, sob, fevers. Pain worse with urination. Comes in waves, radiating to groin on right."   Hospital Course: the following problems were addressed during this visit:   * Ureteral stone with hydronephrosis New.  Urology planning cysto, right ureteroscopy, laser lithotripsy, stone extraction, right retrograde pyelogram, right ureteral stent placement today. DC later if urology is ok   o Covid+: new.  Covid stat positive.  Covid rapid negative today.  Will need another negative test 8 hours from the last for this to be false positive.  Will order one o HTN: borderline.  Cont home meds on dc.  Monitor BP at home and fu with pcp o GERD: cont PPI             Review of Systems:  Review of Systems  Respiratory: Negative for shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain.        Physical Exam: Blood pressure 169/81, pulse 82, temperature 97.8 °F (36.6 °C), temperature source Oral, resp. rate 18, height 5' 6" (167.6 cm), weight 87.1 kg (192 lb), SpO2 98 %. Physical Exam Constitutional:      General: She is not in acute distress. Eyes:     General: No scleral icterus. Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Breath sounds: Decreased breath sounds present. No wheezing.  Abdominal:     Tenderness: There is no abdominal tenderness.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.              Consults:   IP CONSULT TO UROLOGY   Significant Diagnostic Studies:    none     Disposition:  home   Discharge Condition:  fair
papulo urticarial rash, starting 12-24 hrs after vaccine; seen 4/19, treated w/ atarax/valisone cream
Moderna COVID-19 Vaccine EUA.  By evening I was extremely tired, arm was hurting and getting hot, had a headache.  By Tues morning my arm was swollen from elbow to shoulder - hard - red - hot - itchy - painful.  I couldn't lift my arm up, headache, chills, felt like I weighed 2000 lbs, my fingers and toes felt like they were going to explode, had a hard time walking (balance), slept most of the day,  slept most of the night.  Weds I was starting to feel a little better, lesser headache, lesser chills, lesser feeling of weight and extremities exploding, still very tired, arm very painful still red, hot, swollen, itchy, painful -hard from above elbow to shoulder.  Slept.  Better each day, arm still swollen today 4/5/21 but now the size of an egg...red, hot, itchy.