chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient described a large saucer shaped swollen, itchy rash on the deltoid of which the vaccine was administered. Patient denied any pain and other symptoms.
c/o of h/a  p/receivng rabies vax ( day p/administration);
3min p/vax pt stiffened, eyes rolled back, lasted 15-30sec-awoke was crying-appeared to be syncopal episode;
Tightening; heating up; swelling of throat; swelling of throat and chest; throat closing; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosis in May2020, COVID-19 test taken via nasal swab on 01May2020 was positive.  The patient had never had an allergic reaction in her life and she was not allergic to anything that she knew of. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine.The patient received her first vaccine on 10Apr2021. After the shot she felt her throat closing. She experienced Tightening, heating up, swelling of throat and chest within 10 minutes of vaccine administration, also reported as at 14:15. They called the Paramedics, who gave her Benadryl injection when they picked her up from the site where she received her vaccination, which was a drug store. She was then transported to the emergency department. She was hospitalized and treated with Benadryl injection for the Tightening, heating up, swelling of throat and chest. She was monitored for 3-4 hours, and her symptoms were not worsening and she was able to leave the hospital. Ever since, this is the 9th day, everyday she had severe shortness of breath. She had no wheezing. Her chest clenches. It scared her so she had gone to the Emergency Department 2 more times for it. She had gone there 3 times in total. She had been to the Emergency Room a few times and saw doctors there. Her throat closing stopped later that evening and had come back about 4 times. Since then, she was not sure if it was just the sensation of the throat closing because it is coupled with shortness of breath. She had the sensation of throat closing about 4 times. She was short of breath every day since receiving the vaccine and up to 4 times each day. Sometimes it was worse than others. She had it while on the call (19Apr2021) and rated it 4/10. On 14Apr2021 she went to the Emergency Department in the middle of the night. She rated that episode as 9/10. Episodes of symptoms had been ongoing and reoccurring since the day of vaccine administration. She had a COVID-19 test post vaccination in Apr2021 (unknown results). The outcome of  Tightening/ Chest tightness, heating up, swelling of throat and chest, throat closing and severe shortness of breath was not recovered.
Developed urticaria within 30 seconds after receiving routine 12 month immunizations including MMR, Hepatitis A, Varicella, and Influenza. Had received influenza vaccine before without issue. Urticaria on face and left thigh, where Hepatitis A and Varicella immunizations were given. Urticaria resolved after giving benadryl. No respiratory distress, angioedema, or other signs of anaphylaxis.
This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, fever, body ache, diarrhea, chills and sweating was not reported. This report was non-serious.
patient received Quadracel.who was 9 years old/no AE; Medical Assistant selected Quadracel with the intention of reducing the number of injections/no AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2020SA034519 (same reporter).  This case involves a 09-year-old female patient (first patient out of twins) who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which was administered by a Medical Assistant with the intention of reducing number of injections (Off label use; Product administered to patient of inappropriate age).  Patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) (no dosing details reported).  On 11-Dec-2019, the patient received a 0.5 ml 4th single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA (expiry date: 09-Oct-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration and off label use.  It was unknown whether adverse event was noted in the patient or not.  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.
Two weeks following injection 1 I began to break out with large sores all over my left leg and foot.  They were large sores, very red and intensely itched to the point of bleeding.  The then broke out on my left foot with intense itching.  My right leg began to break out with the large sores that somewhat resembled chicken pox with intense itching.  Following the 2 Shingrix injection I began to break out both hands, both arms and both bottoms, mouth, lips and vagina, face.
It was discovered on 01/24/2023 that the clinic had been storing the ProQuad vaccine in the vaccine fridge and not the vaccine freezer.  This patient was identified as having received a dose of the vaccine that was stored improperly.  The patient will be called back to clinic to receive another dose of ProQuad.  No adverse reactions were reported from initial dose.
p/vax pt pain & stiffness in the shoulder area; upper arm extending into her neck;
a 15 year old female patient received a dose of Flublok Quadrivalent/No AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1940, expiry date: 30-JUN-2020 via intramuscular route in the left deltoid on 11-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  The patient has not had any adverse reactions at this time.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Red, bruising, warm, hives, malaise. Pt. tried taking BENADRYL, but no improvement. Pt. was started on cephalexin 500 mg, 1 cap qid x 7 days.
This spontaneous report was received from a 76 years old female patient, referring to herself. The patients medical history included a spinal fusion and her current conditions included high blood pressure. The patient's was allergic to "tons of stuff" including penicillin and codeine; with the last one her reaction was really bad, she stated "I saw a light and heard the nurses all around me".  On an unspecified date in 2017 (reported as recently before the events), the patient was vaccinated with PNEUMOVAX 23 injection, lot number M006922, intramuscularly (dose, frequency and expiration date were not reported), for pneumococcal prevention.  The patient stated that she had received unknown vaccinations for pneumococcal prevention, on unspecified times in the past; maybe 4 times.  Concomitant therapies included gabapentin and metoprolol. On 14-JUN-2017, the patient developed pain/soreness under her arm; this pain was severe, where she could not lift her arm (movement disorder). The patient stated that it felt like the pain was reaching the breast tissue (breast pain) and her spine down to the bra line only, not entire spine (pain in thoracic spine); there was pain in the right lung, too.  The patient also started coughing up yellow (productive cough).  Additionally, she was experiencing a headache since the vaccination and she was "aching all over" (generalized aching).  Patient questioned if there anything wrong with the PNEUMOVAX 23 lot to produce this effect. The physician recomended treatment with acetaminophen (TYLENOL), which reduced in some small the pain. The patient considered this reactions as "severe and scary", as she had been in the doctor's office prior to vaccination, in order to be evaluated for breast cancer (unspecified results). The patient's outcome was reported as not recovered. The causality assessment between PNEUMOVAX 23, pain in extremity, headache, generalized aching, movement disorder, pain in thoracic spine, productive cough, pulmonary pain and breast pain was not reported. Additional information is not expected as there is no consent for follow-up.
Golf ball sized mass swelling, hot to the touch. Painful in movement and palpation. Extreme fatigue for 36 hours.   By 72 hours after the shot the swelling has shrunk in height but spread out to about 4" wide circumference. Still hot to the touch but less painful on movement and palpation.  A lot less
30 min after vaccination patient felt dizzy and syncopal attack, became limp and had poor perfusion but regained normal status in 10 min
Immediately after Tdap injection patient gasp for breath & grabbed chest - face was pale - BP 140/80 at 955 AM. Gave sugar & patient laid down. BP 136/76, pulse 80 at 10 AM. BP 124/66, pulse 72 at 10:10 AM - discharged to home at 1030 with BP 110/66 pulse 72 - patient states felt like he has asthma attack.
Noticed bruising the day after given the flu shot experienced dull ache since then and on and off numbness that last for a few seconds. Bruising resolved 11/12/16. Ache and numbness had not resolved. Worse when laying on left side.
Injection site reaction:  Red, raised, oval, hot-to-the-touch, itchy, 4-6 inches.  No treatment needed.
Chills, nausea, joint pain, muscle/tendon pain, headache, sore arm Lasted 2 days
Received MMR in L arm 8/3/06; parent reported redness and swelling same night, worse next day. No fever. Exam (8/5/06): 7 1/2cm x 8 1/2cm area of tender warm erythema on lat upper l arm, no induration. Impression local MMR reaction. Tx: ice pack, Motrin, MD check if worse.
Spoke with mom of patient and she called to report that patient has a quarter sized redness around the administration site that feels feverish just to the area.  Looked on VIS and it does list it as a mild problem.  Advised mom to monitor and call if develops any worsening or other symptoms.  Also advised mom to use OTC pain medication and rotate warm compresses with ice packs.
PT HAD NO CONTRAINDICATIONS NOTED. PT TOLERATED DOSE #1 ON 1/29/2021 WELL, WITHOUT ANY COMPLICATIONS NOTED. PT BEGAN TO FEEL FLUSHED AND HOT BETWEEN 3 TO 5 MINUTES POST VACCINE. PT WAS TAKEN OUTSIDE TO GET SOME FRESH AIR. PT DENIED SHORTNESS OF AIR/ DIFFICULTY BREATHING. A RED RASH WAS NOTED TO PT'S LUQ OF THE ARM. PT TOOK 20 MLS OF BENADRYL HCL PO. PT'S DOING VITALS WNL. PT REFUSES MEDICAL ATTENTION FROM EMS.
Pt reports 4"x5" swelling at injection site 1 day after administration. Redness and warm to to the touch. She also reports dryness around the mouth. Advised pt to apply ice for swelling and to call back if she isn't getting better. Spoke to pt after the weekend and reports the swelling is completely gone.
Localized induration, redness, swelling in the right upper extremity.  No fever or malaise. Abx: Augmentin.
At approximatley 1535 PT waived down nursing staff and reported "I dont feel so well" Pt also reported at this time feelings of lightheadedness and dizziness. Vitals at this time were BP106/64 HR 90 RR 16 at 91% on RA. Pt presents at this time with significant color change to lips and face, diaphoretic. HR continued to trend down to the 50's-40's. Reports taking BP and GERD medications as prescribed by his PCP. Wife present at this time, reports no HX of any previous similar reaction. Diversion/Group Supervisor notified and EMS routed to scene. Pt transported at 1600.
24 hours post vax, the pt experienced a huge 4 inch reaction that was slightly raised, red, hot, and itchy.
sore arms; body aches; 58 year old male was given PEDIARIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concurrent medical conditions included stem cell transplant.   On 19-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) and the 1st dose of Pediarix (intramuscular, unknown arm). On 19-SEP-2023, less than a day after receiving Shingrix and Pediarix, the patient experienced pain in arm (Verbatim: sore arms), general body pain (Verbatim: body aches) and inappropriate age at vaccine administration (Verbatim: 58 year old male was given PEDIARIX).  The outcome of the pain in arm and general body pain were resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix, Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm and general body pain to be related to Shingrix, Pediarix and Pediarix 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 Information: GSK Receipt date: 25-SEP-2023 The patient was self reported. The patient had undergone stem-cell transplant, rendering all past immunizations useless.  He had begun the revaccination process. He reports that on 19th September 2023 he had his first series of injections, receiving 5 injections total, 3 in one arm and 2 in the other.  He noted that he was given Pediarix as one of the vaccines and was calling the GRC to find out if it was appropriate to receive at his age.  Referred him to his HCP for clarification and he also mentioned that Shingrix was one of the vaccines given.  He reports body aches, and sore arms.  58 year old patient received Pediarix vaccine which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Patient c/o nausea after breakfast.  Attempted to follow normal routine for school.  11AM he c/o increased nausea and not feeling well.  T=102.8.  Placed on Medical Isolation to rest in room.  Placed on clear liquid diet and.  Admin Tylenol 650mg Placed on Vital Signs and Tylenol 650mg Q 4 hours and encourage PO fluid intake.  Monitored.  2/13/16 7AM, he was afebrile and no c/o voiced.  VSS.  Returned to normal routine.
This spontaneous report was received from a healthcare professional via an article published online by unknown source, which was brought to the attention of global safety by a sales representative. It concerns an unspecified number of child patients of unknown age and gender; whose concurrent conditions, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) as shingles vaccine or with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) as chickenpox vaccine (dose, route of administration, lot number and expiration date were not reported) (dose, route of administration, Lot # and expiration date were not reported) for prophylaxis. On an unknown date, within 14 days after of vaccination, the children developed symptoms of keratitis (also reported as after receive a chickenpox or shingles vaccine). At the reporting time, the outcome of keratitis was unknown. The causality between the vaccines and keratitis was not reported. Upon internal review, the keratitis was considered a medically significant event. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information is not expected as we can not contact the physician. Sender's Comments: US-009507513-1702USA002427.
High Fever; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 9-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number H47PB, expiry date unknown) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season. On an unknown date, couple of days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter came in with sibling and each had flu shot and mother called couple of days later with complaints of high fever 105, 104 degrees F. The reporter agreed to follow up with GlaxoSmithKline. The case has been linked to the case US2019AMR178742, reported by same reporter.  .
Fever approx. 102' F. (Acetominophen given.) Indigestion, spitting up, sleeplessness.  Next day and for at least 5 days after, ONE Large DARK PINK SPOT approximately 2" diameter on left rump.  No liquid discharge or scaling, a little bit raised and rough-looking. Recovery from  fever and nausea within 48 hours, so no doctor visit when workweek began again. Spots shrunk and "dried up" more pale over 5-10 days.  Patient's  sister (separate report) of 5 years of age had very similar reaction, only more spots and some vomiting.
Brain fog, lack of ability to focus thoughts. 24ish hours and then it faded.   Pain near injection sight. Onset about 8 hours and lasted for 30ish hours then faded over a few hours. Felt like someone hit my arm with a ball peen hammer. Very localized acute pain.  Extremely tired
tingling and numbness in jaw that lasted about an hour then resolved without problems.  Sore arm lasted about 48 hours and resolved with no further problems.
Moderna COVID- 19 Vaccine EUA  Pt received Dose 1 of Moderna COVID series 1/23/21. Pt developed difficulty breathing, cough, respiratory problems on 1/28/21. Pt tested positive for COVID 2/1/21. Pt had progressively worsening symptoms such as coughing fits which make her feel like she cannot breath until pt presented to ED 2/5/21. Initial pulse ox was 88% on room air. Pt was started on 2 L nasal cannula oxygen. Pt endorsed fever, chils, SOB, minimally productive repetitive harsh cough, diffuse body aches, fatigue, nausea, vomiting, diarrhea, mild generalized abdominal pain, loss of smell, loss of taste, no skin rash. Pt admitted to hospital.  2/6/21: Pt feeling better than day before. States oxygen is helping. Fever resolved. Continues to feel weak and tired. Recieved convalescent plasma in AM. Started remdesivir in PM. Continued on empiric ceftriaxone for bacterial superinfection coverage. Holding off on dexamethasone due to oxygen requirements of 2 L but plan to start if has increased oxygen needs. Enoxaparin started for DVT prophylaxis. Breo continued.  2/7/21: Pt continued to have significant cough. Pt did not like formulary Breo and pt's daughter brought in her home Symbicort for in-hospital use. Cough improved with benzonatate and dextromethorphan. Requiring 1 L of oxygen. Continued remdesivir, enoxaparin, benzonatate, detromethorphan. No evidence of bacterial pneumonia.  2/8/21: Discharged home with Genesis COVID Safe At Home telehealth program.
Occular Inflammation and Uveitis. Vaccine was administered Monday, 8/23.  On 8/24, aches and tiredness and swollen lymph nodes under injection arm.  On 8/27, redness in right eye began if with normal dose of Lotemax once daily.  8/28-8/29, redness increased, sensitivity to light and pain behind eyes increased throughout those two days.  Saw physician who attributed the Uveitis to the vaccination.
Woke up feeling discomfort on the left side of my neck,. By 1:30 PM I felt a hard lump that also moved underneath the skin as I touched it.  The site was not red, just a bit warm. I started taking aspirin and applied salon pass to see if it helped with the swelling but it hasn?t. Woke up today and it is still there and I?m experiencing moderate fatigue.
Presented with seizures on 4/22. Found to have bilateral frontal hemorrhagic contusions. Later found to have venous sinus thrombosis.
asthma; vaccine was not administered in the deltoid, it was given like in the tricep; This is a spontaneous report from a contactable physician. This physician reported for 2 patients. This is 2nd of 2 reports.  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccine was not administered in the deltoid, it was given like in the triceps leading to product administered at inappropriate site on 16Feb2021 and asthma on an unspecified date with outcome of unknown.  Follow-up (17Feb2021): This is a follow-up spontaneous report from a contactable physician. This physician reported for a patient that: Describes the administration site on himself as "from the shoulder 7 inches down and then from the elbow it's another 7 inches. Also would like to know what should be done if this is considered to be an incorrect injection site.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021170851 same reporter/drug/AE with different patient
NO ADVERSE REACTIONS OR EVENTS REPORTED AS OF 11/29/2022. PT (2MONTHS) RECEIVED VACCINES PEDIARIX, PREVNAR, ROTATEQ.  PT RECIVED DOUBLE DOSE OF DTAP AND IPV. NO ADVERSE REACTIONS HAVE BEEN REPORTED BY MOTHER AS OF 11/29/22 @9:24AM WHEN NOTIFIED OF ERROR MY MA.