chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a case of an 18 month old boy who during a routine 18-month well visit developed facial swelling, generalized hives, and respiratory distress, within 5 minutes following vaccination with DTaP #4, IPV #3, and Prevnar #4 at the doctors office. All of these vaccines had been given previously without any reaction.  The child was said to have had a resolving URI and otitis media which started 6 days prior to episode and had been on amoxicillin, which he had not yet taken on the day of episode. He also had mild eczema controlled with occasional over-the-counter hydrocortisone as an infant and but now Aquaphor alone seems to be helping. He had some mild wheezing with a bout of croup last fall and required a course of Orapred. He has no known food allergies, but has avoided peanut butter and shellfish. He does not appear to be allergic to animals. He has been exposed to cats at daycare without any problems. He does not have chronic nasal problems and is not prone to recurrent infections. Both parents have allergic rhinitis and father has had sinus surgery. The family has two pet Labrador retrievers. They live in a single-family home and there is no obvious exposure to mold.  At the doctors office he was given subcutaneous epinephrine 0.1cc, Benadryl 1½ teaspoon p.o. Within 45 minutes his rash resolved but he had wheezing. Therefore he received albuterol 0.5cc which improved the wheezing. He was subsequently taken to ER.  On admission he was found to be alert, playful and in no respiratory distress. Respiratory exam revealed scattered wheezing but no flaring, grunting or retraction.  The impression was that of anaphylaxis to one of three vaccines. A likely culprit was said to be the adjuvant protein contained in the Prevnar. It was also possible he could be allergic to one of the other vaccines. He was placed on I.V Benadryl 12 mg q.4h, Solumedrol 24 mg stat, and albuterol 0.5 q 1h as needed.  On a follow-up visit 3 weeks after the onset of symptoms an Allergen skin test was performed. It was positive to egg 2+, soy 2+, cashew 2+, and walnut 1+. Negative responses to fish, peanut milk, casein, beef, chicken, wheat, oats, shellfish, and almond were obtained.   Skin testing to vaccines performed 6 weeks post episode showed mild positive reaction to DTaP at 1:100 dilution and significantly positive reaction at the 1:10 dilutions. DTaP gave a 2+ reaction with a 5-mm wheal and 27-mm flare at full strength. Prevnar gave a 2+ reaction with a 5-mm wheal and a 30-mm flare to the 1:10 dilution. There was negative reaction to IPV.
Alternating chills and fever (103), severe body aches, hand numbness, frontal headache, insomnia
Information has been received from a health professional concerning a 13 month old male who on 07/20/2004 was vaccinated with varicella virus vaccine live.  On 07/20/2004 the patient experienced injection site reaction which went away the evening of the injection.  On approximately 07/27/2004 the patient experienced developed 5 lesions in difuse locations.  The patient was seen by the physician and he did not require any prescription treatments.  Subsequently the patient recovered.  It was reported that the patient was exposed to a 13 month old female who had a breakthrough case of varicella.  There was no product quality complaint involved.  The reporter also indicated that another patient had similar experience following exposure to varicella virus vaccine live.  Additional information has been requested.
I see my primary care every month and as different symptoms started coming up we started more testing. My pcp and specialist have started looking at my numbers and monitoring them. Started having worsening edema to the point in 08/2021 my skin would break and I would have open sores, my blood pressure was in dangerous highs and now causing issues with heart, lungs, kidneys and vision (almost completely blind). They put in a port to start dialysis 19 days ago.
Shingles; Feeling a strong pain on my left buttock; Pain moved to left part of abdomen and became unbearable; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in right arm on 29Apr2021 04:00 (Batch/Lot number: EWO173, Expiration Date: was not reported, Age at Vaccination: 53-year-old) as DOSE 2, single for covid-19 immunisation. The patient's medical history included High blood pressure, acid reflux, ADD, obesity. The concomitant medication included Vyvanse, Benazepril, Omeprazole, Loratadine. On 29Apr2021 04:45, patient experienced a strong pain on left buttock about 30 minutes after getting the second vaccine. It came and went for the next 4 weeks. On 29May2021, she went to urgent care when pain moved to left part of abdomen and became unbearable. Urgent care doctor sent her to ER. ER did ekg and other tests but couldn't figure out what was causing pain. Patient reported they gave me a small dose of morphine, then sent me home. Told me to take 1000 mil of Tylenol for pain. On 31May2021, I awakened with rash all over left abdomen, went to urgent care, was diagnosed with shingles. Patient took Valacyclovir HCL 1 gram as treatment for events. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, he was not tested for COVID-19. Patient had no allergies. The outcome of all events was recovered with Sequel on an unspecified date in 2021.
Pain in left upper arm, did not move arm, throat seized, difficulty breathing, nausea, loss of appetite, sleeplessness, congestion, chest and nasal congestion, coughing, feeling ill, malaise, felt like having pneumonia, chills.
fever that lasted 24 h; chills that lasted 24 h; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever that lasted 24 h) and CHILLS (chills that lasted 24 h) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever that lasted 24 h) and CHILLS (chills that lasted 24 h). At the time of the report, PYREXIA (fever that lasted 24 h) and CHILLS (chills that lasted 24 h) had resolved.            Patient's regular medication included blood thinner medication . No treatment  medications were reported. Patient enquired if she can receive the 2nd booster and if she can receive Pfizer instead of Moderna for the 2nd booster.   Reporter did not allow further contact
pt devel hot, itchy hive like area just adjacent & posterior to inject site; fever; CMS intact; no systemic sx; rxn occurred 6 days p/inject;
Moderna COVID-19 Vaccine EUA    3/12/21: The patient was started on antibitoics outpatient Tuesday for bronchiolitis. Covid test was done, no results yet. Pt daughter stated got better yesterday today confused. 85-year-old woman who presented with 2 days history of cough, chest discomfort and shortness of breath.  She reports insidious onset of symptoms 2 days ago cough which was initially dry, then productive of scanty whitish sputum. She also reported associated shortness of breath and pleuritic mid chest discomfort. She denies any fever, chills, nausea or vomiting. She denies any known contact with individual diagnosed with been tested with COVID-19 infection, reports compliance with masking directives. She is up-to-date with her COVID-19 vaccination, 2nd short of COVID-19 vaccine was administered last Saturday. Chest in her primary care physician yesterday and been diagnosed with bronchiolitis, prescribed oral Augmentin and Medrol Dosepak without any improvement in symptoms. She presented to emergency department today and was found to be hypoxic to 82% on room air. At present she has required supplemental oxygen at 5-8 liters/minute. She will be admitted to the hospitalist service for further treatment and evaluation.    3/20/21: She is s/p plasma, antibiotics (aztreonam, vancomycin), no remdesivir due to poor renal function. She has been on decadron 3/12 to date (to complete 10 day course) She was able to be weaned down to 1 L NC oxygen while on admission with improved symptoms. Plan is to discharge to rehab today.
left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.
Rash with small white bumps from the knee to the upper thigh, with some discoloration of the skin toward the inner thigh. Redness noted all over the thigh area
patient that qualifies for FLUZONE HD was instead administered FLUZONE QUAD., with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA383250(CLUSTER).  This case involves an unknown age and unknown gender patient who qualifies for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was instead administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event while receiving vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE and  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, dose, formulation, route,lot number not reported) in unknown administration site both for prophylactic vaccination.  On an unknown date the patient reported  a non-serious patient that qualifies for fluzone hd was instead administered fluzone quad with no reported adverse event (Wrong product administered) (unknown latency).   Action taken:not applicable.  At time of reporting, the outcome was Unknown for the event Wrong product administered.   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.
Anaphylaxis. Onset 10 minutes. Initially responsive to epinephrine, subsequently not. Ultimately requiring endotracheal intubation
inconsolable crying, hives on back;sx from 31JUL96PM to 1AUG96 when seen by MD;tx DPH;
1st shot bad head ache and chills.; 1st shot bad head ache and chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 08:15 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Covid prior vaccination: Yes. Concomitant medication(s) included: INSULIN. Past drug history included: Ibuprofen, reaction(s): "allergy"; Zpack, reaction(s): "Allergy". The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "1st shot bad head ache and chills."; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "1st shot bad head ache and chills".  Additional information: the patient did not receive any other vaccine in four weeks. Other medications in two weeks: Insulin. The patient had not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax;thigh red, edematous, warm to touch, firm to touch; seen by MD; recv augmentin x 10 days; also seen in clinic ;
pt c/o localized reaction after COVID Vaccine 9 days ago on 5 Jan 2021 on L Deltoid. 1 day after the vaccination pt felt tired that improved within 24hrs. started to develop rash with itchiness on the site x 2 days ago, getting bigger in size
received vaccine after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine after temperature excursion) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine after temperature excursion). On 18-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine after temperature excursion) 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.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
ITP with wet purpura and platelet count <10. No ICH at the time of admission.
In April 2022, I was flying out of the area. When I reached my destination, my eyes felt dry. Also, the right eyelid had drooped. It may have started a day or two prior, but I didn't notice it, as I thought I was just tired. However, it was definitely noticeable when I reached my destination. We stayed where we were for 5 days. When we returned home, I made an appointment with my doctor. I saw a physician's assistant and underwent a blood test that was ordered by the doctor. It was found that my blood had very high levels of acetylcholine, and it is suspected that I have myasthenia gravis. I am scheduled to see the physician's assistant again on 6/4/2022.
Telephone call received from client to health dept. on 7/27/06. She states that she unknowingly was pregnant when she received MMR on 6/23/06,  on that day, she stated that she was not pregnant and did not plan on becoming pregnant for 3 mos. and her LMP was 5/20/06. She is under the care of her OB-GYN who is aware of her MMR vaccination.
Patient received FLUMIST at a wellness fair on Saturday 10/12/13 at 10:30 am and presented with hives that evening and again the following morning and evening.
Hurt like hell, when she injected in my shoulder.  She said to make sure I move my arm the rest of that day to help relief the pain.
PATIENT DEVELOPED SHINGLE INFECTION AFTER GETTING SHINGRIX. SYMPTOMS WERE CONFIRMED BY MD. RASHES WITH BLISTERS ON CHEST/BACK/NECK
Information has been received from a nurse referring to a female patient of unknown age (one of twins). No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with ROTATEQ (lot#, expiration date and dose unspecified), orally. No concomitant medication was reported. She sought medical attention at the office of nurse for a routine exam on 29-MAY-2015 and was diagnosed with an ear infection. No lab diagnostics studies were performed. The outcome of event was reported as not resolved. This is one of several reports received from the same source. Additional information has been requested.
tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive. Clinical course: The patient got a covid vaccine she tested positive and now wanted to know when she can take the booster after tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
States with vaccine done on 6/20/00, broke out with red, raised rash all over body, lasting approx. 48 hours. No fever and no obvious discomfort. Complained of "lump on right thigh" that is still present.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Hep B (manufacturer unspecified) and ENGERIX B (GlaxoSmithKline). Concurrent vaccination included tdap vaccine (non-gsk); non-GSK manufacturer given on 21 January 2010. On 24 July 1992, 25 August 1992 and 28 January 1993 the subject received 1st dose, 2nd dose and 3rd dose of Hep B (1ml, unknown route, unknown deltoid). On an unknown date the subject experienced not responding to therapy. The subject's titers were drawn and were negative. On 12 July 2007, 21 August 2007 and 21 January 2010 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 3 March 2010, 41 days after 3rd vaccination with ENGERIX B, 2 years after 2nd vaccination with ENGERIX B, 3 years after 1st vaccination with ENGERIX B, 17 years after 3rd vaccination with Hep B, 18 years after 2nd and 1st vaccination with Hep B, the subject experienced not responding to therapy. The subject's titers were drawn on 3 March 2010 and were 0.2 (units not provided). The subject received a booster dose (or 4th) dose of ENGERIX B on 5 March 2010 (1mL, unknown route, unknown deltoid). Repeat titer was drawn on 10 August 2011, 17 months after the booster dose of ENGERIX B and the subject experienced not responding to therapy. The titer was less than 0.1 (units not specified). This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following Hep B vaccination. This is case 4 of 7 (see case IDs A0947199A, A0947239A, A0947240A, A0947242A-A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 03 March 2010, the subject's hepatitis B surface antibody was 0.26 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). On 08 August 2011, the subject's hepatitis B surface antibody was 0.53 mIU/mL. All doses of Hep B and ENGERIX B were administered intramuscularly. All doses of Hep B and the 1st and 4th doses of ENGERIX B were administered in the left deltoid. The 2nd and 3rd doses of ENGERIX B were administered in the right deltoid.
Appearacne of macular, erythematous lesion, approximately 2 weeks after anthrax #3 on wrist are of left arm. A few days later serveral lesions appeared in the same area, which were pruritic. Saw dermatologist on 03/20/03 and tried a number of trial treatments, which worsened rash. The placed on oral steroids starting with 80mg and tapering of 4 days. Lesions, resolving until dose decreased to prednisone, then rash worsened. Rash on other forearm, legs and neck.
swelling, redness, pain in rt arm;MD rx cleocin, DPH, APAP for pain;
I'm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (I'm sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MYALGIA (I'm sore). At the time of the report, MYALGIA (I'm sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Received booster Pfizer vaccine Tuesday Dec 14, started having high blood pressure 197/92 Wednesday December 15. After four days high blood pressure, grand daughter called EMS and pt. had a stroke. She was in the hospital from 12-18 to 12-21. It is believed to have been caused by her high blood pressure (per Neurologist and Cardiologist). She has never had blood pressure this high before. Her blood pressure got over 200.
Presented to ER 10/31/10 with headache, blurred vision, numbness on Rt side progressing to both sides. Stroke work up negative - Adm. to ICU. Progressive LOC, intubated. Transferred to another hospital.
Five days after I received the H1N1 mist spray, I developed hives (small red bumps) on parts of my body. I continue to have the hives.
Soreness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the injection arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM OXIDE, COLECALCIFEROL (VIT D [COLECALCIFEROL]), LEVOTHYROXINE and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the injection arm). On 21-Mar-2021, PAIN IN EXTREMITY (Soreness in the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient didn't take any medications to treat the symptoms.
Reaction covered whole (R) thigh wrapping around thigh, radiating to muscles in (R) side of groin-red hard hot to touch, area groin to knee- MD visit 10/12/16.