chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After all the girls were given the vaccine, many were becoming disabled and/or terminal; After all the girls were given the vaccine, many were becoming disabled and/or terminal; This spontaneous report was received from a consumer refers to unknown number of female patients of unknown age. The patients' medical history, concurrent conditions, historical dugs and concomitant medications were not reported. On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, frequency, route, lot # and expiration date not reported) for prophylaxis. It was reported that, after all the girls were given the vaccine, many were becoming disabled (adverse event) and/or terminal (terminal state). The outcome of the events was unknown. The causality assessment was not provided by the reporter.  The reporter considered the adverse event to be disabling.  Upon internal review, terminal state was determined to be medically significant.  This is one of several reports received from the same reporter (1909USA004907).; Sender's Comments:  US-009507513-1909USA004907:
verbally verified and signed written attestation that he had not gotten any Covid vaccine before the Moderna shot he got, but it was later found in our charts that he had gotten a dose of the Janssen J&J Covid vaccine on 3/15/21. did not have any reaction or complications during his observation period or any time after, that we are aware of.
The child's mother reported to the PCP's office 1/11/05 of temp 104 around 11:00 PM and the child had a generalized seizure at 1:00 AM which lasted minutes and the child was not breathing and lips were blue. Parents called 911 and administered Epi-Pen Jr in case symptoms peanut allergy related.
Information has been received from a health professional concerning a patient who was vaccinated with Rotateq. The nurse reported that the patient received the second dose of Rotateq 2 weeks after the first dose. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.  Follow up information has been received from a health professional who reported that no adverse event has been reported.."the mother of the child was only concerned that the vaccine was given within two weeks of the first dose.  Additional information is not expected.
10 days after injection patient was tired, headache, restless, breakthrough seizures, no fever, lasted for 4 days.  22 days after injection 3 itchy raised red spots appeared on neck, trunk, and forearm.  24 days after injection hard lump where injection was given appeared.  26 days after injection entire back of upper arm where injection was given was warm, red, and swollen - lump was still present.  Redness and swelling of back of arm disappeared after 3 days of treating with topical prescription antibiotic.  During this reaction and after it resolved itself the oral issue with ulcers worsened significantly.
no additional AEs reported; Caller reported expired dose of VAQTA administered; This spontaneous report was received from a medical assistant and refers to a 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-MAR-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, 1 ml, lot # T034003, expiration date: 28-MAR-2022, first dose, administered intramuscularly in left arm (strength was not provided) for prophylaxis (expired product administered). It was reported that the vaccine was reserviced/refurbished prior to the administration. The reporter stated that prescription drug treatment was required due to the experience, but no details regarding used drugs were provided. The outcome of the event was reported as recovered/resolved (coded as unknown per company guideline). No additional adverse events were reported (no adverse event).
hard at injection site; Headache; itchy rash at injection site; swelling at injection site; purple, reddish mottling at injection site; received shot in buttocks; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks), VACCINATION SITE MASS (hard at injection site), HEADACHE (Headache), VACCINATION SITE RASH (itchy rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On 06-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks). On 08-Feb-2021, the patient experienced VACCINATION SITE MASS (hard at injection site), HEADACHE (Headache), VACCINATION SITE RASH (itchy rash at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (purple, reddish mottling at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of 50 mg; IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks) and HEADACHE (Headache) had resolved, VACCINATION SITE MASS (hard at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (purple, reddish mottling at injection site) outcome was unknown and VACCINATION SITE RASH (itchy rash at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she had an allergic reaction to a tetanus shot in 1970  No concomitant medications were reported
Dx'd with autoimmune disease, systemic lupus erythematosus. History of total left hip replacement. (Pt had 2nd Engerix-B on 9/18/92 and 3rd Engerix-B on 3/10/93)
Child developed fever, decreased activity, decreased oral intake. Office visit: (+) viral URI, pharyngitis.
COVID Breakthrough  Pfizer Dose 1 2/19/21 (EN6200) Pfizer Dose 2 3/12/21 (EN6205) COVID Positive 8/23/21 Presented to and discharged from ED 8/23/21  8/25/21: History is obtained from patient as well as by personal review of records.  The patient is 79-year-old lady with known history of hypertension, atrial fibrillation, chronic anticoagulation therapy and other medical problems.  She complained of nausea, vomiting , diarrhea and  generalized weakness for 3 days.  She tested positive for  SARS-CoV-2  on  8/23/2021. She was started on azithromycin and Zofran.  She continued to have worsening generalized weakness.  She was unable to ambulate and had to crawl to reach phone at her home.  She also complained of subjective fevers.  She had temperature of 101° F on arrival in emergency department.  She was hypoxic with pulse ox of 85% on room air.  Feels better after oxygen supplementation. She had been previously vaccinated with both doses of Pfizer SARS-CoV-2 vaccines.  First dose in February and 2nd in March.  8/29/21: Improved and stable. Patient is being discharged home. you will receive a kit in the mail with: Blood Pressure cuff, thermometer and Pulse Ox; please set up and use this equipment to monitor your Covid recovery. self isolate for 10 days.
After receiving vaccine in AM. The P.M. complaining of sneezing. 10/20/10 whole body-muscle/joint ache. "I felt out of it". C/o sneezing throughout night missed 10/20/10 work. By 3pm 10/20 1pm resolved.
This spontaneous report as received from a pharmacist refers to an approximately 63 year old female patient. Patient's concurrent condition includes asthma, penicillin and environmental allergies. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K004542, expiry date 19-AUG-2015, 0.5 ml, intramuscular in the right arm. The patient was also administered FLUVIRIN concomitantly in her left arm at the same time. Post vaccination, on the same day (23-SEP-2014) the patient developed eight inch swelling of the right arm that extended to the elbow, her arm was itchy, painful and she could not bend it (disability). The patient sought medical attention and called the pharmacy. Treatment was over the counter BENADRYL and ice pack. The pharmacist indicated that during the patient's call back she reported that her right arm was little less swollen now but she still could not bend it. Patient did not have any problem in the left arm where the FLUVIRIN was injected. The pharmacist indicated that the patient was unsure if she ever had PNEUMOVAX 23 injection before or not. Action taken with the suspect therapy was not reported. The outcome was events were reported as not recovered. Causal relationship of the events with suspect drug was not reported. The reporter considered the event she cannot bend it serious due to disability. Additional information has been requested.
red rash on face; school called mom on Thursday itching on body, about 10AM; mom stated rash got worse;
8 you client presented to  Vaccine clinic for 2nd dose of Pfizer Covid-19 vaccine.  Client was vaccinated at  Internal Medicine on 09/25/2021 prior to the vaccine being approved for 5 - 11 yo's.   Per client's mother she was given "1/3 the adult dose".    Attempted to call the clinic to verify information but was unable to get through due to the clinic being closed for the day.   The MD involved was Dr.  who is a friend of the client's father, Dr.   Per the client's mother, they were afraid of the client's father bringing home Covid from the hospital and wanted to get her vaccinated to protect her. Vaccine not logged into the  system.  Client was not vaccinated at the Health Department vaccine clinic.
I was schedule for an annual checkup, everything was fine, my blood pressure was a little high, he listens to my heart and found an Atrial fibrillation, I had Shortness of breath, I had COVID-19 over the holidays, a couple of days before Christmas, it was a mild case. I am seeing my Cardiologist and I schedule for a procedural in July.
Mom describes over phone that child's left arm (DTaP and IPV administered) is hot, red, swollen from elbow to shoulder, not painful to touch. Child given Tylenol. RN suggested continuing Tylenol, Motrin, Cold compress to arm. Child seeing her neurologist in 1 hr-will be evaluated further, there is no respiratory symptoms. Shots administered on 4/18/07. Parent calling 4/20/07.
Patient became light headed, vision went black, and she fell to the ground. Blood pressure and heart rate were slightly elevated from baseline. Blood sugar was normal. Became to feel better quickly (within 10 minutes). Patient was also checked out by paramedics and released home upon evaluation. No medical or pharmacologic treatments were given or provided.
Loss of verbal communication, gradual reversal of words (verbalization) achieved by 18 months of age. Medical impressions of developmental delay, communication delays (speech). Gross motor delays. Mercury toxicity. RX: participation in Early Childhood Development Therapy, Speech, Physical and Children's Center. C/O sensory and developmental delays-verbal
breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning; Soreness on the right side, under the arm; The whole breast center where the mammillary glands are located were itching; breast is still tender; Soreness on the right side, toward the collar bone; body aches; little sore arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (little sore arm), BREAST TENDERNESS (breast is still tender), BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning) and AXILLARY PAIN (Soreness on the right side, under the arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (little sore arm) and CHILLS (chills). On 04-Mar-2021, the patient experienced BREAST TENDERNESS (breast is still tender), AXILLARY PAIN (Soreness on the right side, under the arm), PRURITUS (The whole breast center where the mammillary glands are located were itching) and ARTHRALGIA (Soreness on the right side, toward the collar bone). On an unknown date, the patient experienced BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (little sore arm), BREAST TENDERNESS (breast is still tender), BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning), AXILLARY PAIN (Soreness on the right side, under the arm), PRURITUS (The whole breast center where the mammillary glands are located were itching), CHILLS (chills) and ARTHRALGIA (Soreness on the right side, toward the collar bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information not provided.
Palpitations with heart rate over 160- 1st episode on 2/5/21 within 5 minutes of receiving vaccine.  Transferred to Urgent care for monitoring and EKG. EKG reported as normal. Reports she had a couple more heart racing episodes while sleeping  overnight Friday 2/5 into Saturday morning;  each episode lasted less than 2 minutes and not to the extent of episode on 2/5/21.
Swelling under left eye on May 18, swelling under nose om May 20, and top lip swollen on May 22...
Based on follow up received on 4 February 2015 this case became medically confirmed. Initial unsolicited report received from Consumer on 01 December 2014. A 82-year-old male patient, had medical history of cancer in remission and he was on chemo treatments and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in the left deltoid on 17 November 2014. On 18 November 2014, the patient had experienced bad taste, dry mouth, arm pain, 24 hour after vaccination tingling on the tongue, outside of the mouth just below the lips and left side of the chin became numb. It was also reported that patient visited the dentist and no cause was found. The patient spoke to his oncologist who told him since he hasn't been on treatments for such a long time; it is unlikely caused by the chemo treatments. Laboratory investigations and corrective treatments were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included no known drug allergy and cancer in remission were reported. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Followup information received from a health care professional on 4 February 2015. The batch number of the vaccine was reported as U5100AA and expiry date reported as 30 June 2015. Follow-up information received from a physician on 17 March 2015. No additional information to provide. Documents held by sender: none.
Ongoing and worsening Diarrhea especially after 2nd dose which was on 3/31/21.  Moderna #032B21A. (Can?t read number too well on card so it might be 0321321A) As of 5/22/21 saw G.P. And am being referred to Gastroenterologist for possible gallbladder connection to diarrhea.  Inflamed lymph nodes in groin area has been ongoing too since 1st shot.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021 at 4:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Patient were given dose from vial  that were stored in an ultracold freezer which is colder than they should have been. No treatment medication were reported.  This case was linked to MOD-2021-402935 (Patient Link).
Patient is fully vaccinated.  Presented to ED with generalized body aches.   62-year-old male who presents to use the chief complaint of generalized body aches for 1 day. Patient tested positive for COVID 4 days ago. He denies any chest pain or fever. Has not taken any medication for pain relief. c/o shortness of breath.  patient was afebrile with a HR of 78, RR of 23 and oxygen saturation of 94% on room air. No acute distress on exam. Chest x-ray showed no acute process. Lab workup was essentially non-significant. Patient was given a dose of IV Toradol in the ED. Patient is stable for discharge. Patient will return to the ED if symptoms change, worsen or persist.
a patient received an expired dose of Menactra/ No AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) in the .  This case involves a 16 years old male patient who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Oral solution (batch number: U6565AB and expiry date: 28-MAR-2021, Strength: standard) via intramuscular route in the right arm on 30-Mar-2021 for prophylactic vaccination (Expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.   List concomitant or no other vaccines: None.  It was an actual medication error due to expired vaccine used (latency: same day).  Potential Product Technique Complain: No, Reporter relationship: HCP, Product used and Still using product: No.  No reported adverse event.  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.
Pneumovax did not work; This spontaneous report has been received from the patient's daughter, via Pfizer (Manufacturer control #2021030235), concerning a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #, expiration date, dose, and route of administration were not provided) as prophylaxis. However, it was reported that it did not work (Drug ineffective). Therefore, she had to take the other one (unspecified).   The causal assessment between drug ineffective and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Patient reported chest pain and shortness of breath and a feeling of malaise 2 minutes after her initial COVID - 19 vaccine. She took her albuterol inhaler and after about 30 minutes her breathing returned to normal.  Allergy was caught and noted on 5/14 when the patient came to Expo for their second dose.  She is considering coming back next week, once she would be eligible for the Johnson and Johnson vaccine.
severe arm pain with movement (7 out of 10 on pain scale), which began a few hours after the vaccine and lasted until mid-afternoon on 2/3/21.  Now it's dull and more consistent with the flu vaccine. Fatigue evening of 2/2 and lasting until mid-afternoon 2/3/21.  resolved. Body aches beginning on morning of 2/3 and lasting until mid-afternoon on 2/3.  resolved.
hives under her chin they are red and itchy; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives under her chin they are red and itchy), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21 and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 10-Apr-2021, the patient experienced URTICARIA (hives under her chin they are red and itchy). On 10-Apr-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, URTICARIA (hives under her chin they are red and itchy) outcome was unknown.            No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Child in LHU 1-31-06 for immunizations. F reports that G M noted "bumps" on upper LA when she remained band-aid on 2-1-06. No fever. Child saw Dr on 2-10-06 for cough-He saw "bumps" and said it may have been a reaction but he didi not think it was serious because the bumps "were going away" child in LHU today as redness or swelling note at injection sites.  F reports no fever.
Pfizer-BioNTech COVID-19 Vaccine EUA  Tongue swelling, throat tightness to the point patient did not feel comfortable to swallow oral Benadryl. At 11:30 am patient given IM Benadryl 50mg.
Breakthrough case admission after 2 vaccines Pfizer 1/21/21 lot# EL9261;  Pfizer 2/15/21 lot# El9267
Case number PHEH2015US023382, is an initial spontaneous report received from a healthcare professional on 09 Nov 2015. This report refers to a 5 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173987) intramuscularly at a dose of 0.5 ml on 08 Nov 2015. No adverse event was reported following this maladministration.
MOC denied hx of convuls or prior rxn to vax; pt recvd vax & 1/2 hr later was drowsy, shaking & had a high fever; called 911; pt takne to hosp, kept for 24 hrs observation; mom stated MD explained rxn was due to high fever;