chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She started experiencing dizziness; her heart was fluttering a little bit; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (her heart was fluttering a little bit) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was never diagnosed with COVID-19.  Concurrent medical conditions included Penicillin allergy (Patient was allergic to penicillin and does receive a shot every month for allergies).    On 10-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIZZINESS (She started experiencing dizziness). In November 2023, the patient experienced ARRHYTHMIA (her heart was fluttering a little bit) (seriousness criterion medically significant). In November 2023, ARRHYTHMIA (her heart was fluttering a little bit) had resolved. At the time of the report, DIZZINESS (She started experiencing dizziness) had not resolved.            No concomitant medications were reported.  On 11-Nov-2023, she started experiencing dizziness. She told that even on that morning of reporting day, when she woke up, she felt a little dizzy, but it was on and off now.  In addition, her heart was fluttering a little bit. She felt that it was beating kind of fast, but that resolved by itself and she felt fine now. She did not think that it had anything to do with the vaccine. She had received all Moderna COVID-19 shots in the past.   No treatment information was provided by the reporter. Company comment:  This spontaneous case concerns a 74-year-old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of arrhythmia (reported as heart as fluttering a little bit) which occurred in context of SPIKEVAX 2023-2024 dose administration, which was 4th dose of COVID-19 vaccination schedule. Latency cannot be calculated due to exact event onset date unknown, however it was provided that it occurred during the same month of vaccination.  The patient was previously vaccinated with Moderna vaccine (primary series and 3rd booster dose) on unknown dates in the past and the patient experienced nausea and dizziness after 2nd dose and dizziness after 3rd dose. The event was accompanied by dizziness, which started the next day after vaccination; it as on and off. In addition, the patient felt that heart was beating kind of fast, but that resolved by itself and she felt fine now. No further clinical information or details on clinical course, medical history, etiologic and diagnostic work up with treatment were provided for medical review. Event outcome was recovered at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to MOD-2023-750145 (Patient Link).   Reporter did not allow further contact
Approximately 8 hours after vaccine, states getting chills, followed by a fever of 102.6 degrees F that lasted over night and a lower fever between 100/101 degrees f the follow day. Felt exhausted and muscle aches and dizzy. By Sunday was just tired with no fever. And felt almost 100% by Sunday evening (58 hours after vaccine).
Pt received the Prevnar13 and Adacel on 5/21/15 got a local reaction to the Prevnar vacc within one hr. Was seen at our office on 5/22/15 not treatment necessary. Spoke to patient on 5/26/15 pt is dong fine. The swelling and redness she had on L arm from Prevnar13 is all gone.
Mother reported potential reaction to patient on 3/15/13. States 7 days after FLUMIST child experienced esotropia. Child was seen by 2 ophthal consult as well as neurologist & infectious disease. Mother states sx has almost completely resolved however Inf. Disease MD advised to report to VAERS.
Client was administered vaccines, before giving vaccine client said he had taken some Benadryl recently for allergies.  After receiving vaccines client sat down in waiting room.  Minutes later client complained of not feeling well, then slumped over in chair and became pale and unresponsive. Client was supported in chair by nurse. Client became rigid, eyes rolled back, and biting tongue.  Another nurse arrived with smelling salts, administered with no response.  Client was moved to the floor with feet elevated.  Client had bouts of apnea lasting 10-15 seconds X5 episodes.  Pulse rapid and weak.  Oxygen administered and 911 called.  Client started to breathe slowly, color returning, still no communication.  Parents were called.  Client continued to improve and able to respond. Complained of nausea and tingling in legs. EMT's arrived and treated client.  Client transported to hospital.  Parents arrived later and were informed of clients condition and referred to ER.
Patient called approx. 3 PM 12/18/17 and said he has pain in his shoulder area where injection was given. ADVIL or TYLENOL relieves pain or soreness but keeps coming back.
Initial report was received on 29 September 2011 from an electronic lay press article. A 13 month-old male patient, who "acted like other normal toddlers-he cruised around, talked and used utensil", had received theHib VACCINE(manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, had a severe regression. He could no longer walk, talk, eat or roll over. He was evaluated for muscular dystrophy and other neurological disorders. The patient attended a preschool for the blind. Ten days prior to his fourth birthday he was diagnosed with Haemophilus influenza type b (Hib) and staph. By his fourth birthday, he was non-verbal. He was diagnosed with autism, mental retardation, cortical visual impairment and a non-functioning immune system. According the patient's mother, "he didn't get the antibodies from his vaccine. he got the disease. The doctors weren't looking for it because he was vaccinated." The patient's outcome was not recovered. Documents held by sender: none.
1 week post injection (4-21-2021) I woke up with red, raised splotches around and under the injection site. Area is itchy, firm, and warm to the touch. Treating with oral Benadryl and topical hydrocortisone cream.   4/22/2021- same symptoms, but the affected area has nearly doubled in size
Information has been received from a licensed practical nurse, concerning a patient (age and gender not specified) in October 2007, was vaccinated IM with a dose, 0.5 ml, PNEUMOVAX 23 (lot #655290/0959F). In October 2007, the patient developed "a big welt at the injection site." The patient recovered "within the week" of the vaccination. The reporter felt that developed a big welt at the injection site was related to therapy with PNEUMOVAX 23. The patient sought unspecified medial attention. This is one of two reports received from the same source (WAES #0711USA00003) following vaccination with PNEUMOVAX 23 (lot #655290/0959F). The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 29 SEP 2021: contains No New Information.
Two areas of Redness, Swellling and slight heat but no pain or itching. One of 1/2" on injection site and another of 1 1/2" @ 2" below. No systemic symptoms
This spontaneous report was received from a nurse who reported that on 15-MAY-2017, an unspecified patient (age and gender unknown), was administered an expired dose of VARIVAX (lot # L017143, expiry date 13-MAY-2017) reconstituted with sterile diluent (lot # and expiry date were unknown). No adverse effects were reported. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered to be not related to sterile diluent and VARIVAX. Additional information has been requested.
On 12/1/2018 my left arm wasn't getting better at times I feel numbness in my hand and upper part of my arm it feels weakness, aches.
Severe chills, runny nose, and rapid heartbeat. Pt states symptoms resolved after 30 minutes. Pt did not seek medical attention.
fever, nausea, vomiting w/in 4 hrs p/vax given; seen by MD next day advised no further measles immun;
Last Moderna vaccine March 3, 2021. On March 17 began not feeling well.  Never felt this way.  Then on March 25 had severe low abdominal pain that sent her to ER.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/24/21 (EN6198) Pfizer Dose 2 3/17/21 (EN6207) COVID Positive 11/3/21  11/3/21: Patient is a 71-year-old male from home who came to the ER through EMS services following a fall. Patient stayed in the ground for a while until family member notified EMS services.  Patient denies losing consciousness and head injury. ER blood work showing CK level 14,378, lactic acid 3.1, elevated LFTs, proBNP 245. Chest x-ray , pelvis and lateral hip with no acute processes and he has acceptable vital signs.  He was treated with IV fluid and transfer to the medical unit.   Upon arrival to the medical unit patient was noted alert and oriented times 3. He answered questions appropriately and denies any discomfort. His COVID-19 pneumonia later on came back positive. He reports increased weakness for unable to do much several days unable to do much. Patient denies nausea vomiting, fevers and chills, headache, shortness of breath any discomfort at this . Patient's past medical history significant with type 2 diabetes, hypertension, hyperlipidemia and sleep apnea. Patient is being admitted into the medical unit for further management in his agreeable to stay in hospital.  Will order PT eval for discharge recommendation.  Patient reported receiving to COVID-19 vaccination in who is working on getting his booster.  11/9/21: The patient is a 71-year-old male from home who came to the ER on 11/03/2021 through EMS services following a fall. Patient stayed in the ground for a while until family member notified EMS services. Patient denies losing consciousness and head injury. ER blood work showing CK level 14,378, lactic acid 3.1, elevated LFTs, proBNP 245. Chest x-ray , pelvis and lateral hip with no acute processes and he has acceptable vital signs. He was admitted into the medical unit and treated with IV fluid. His COVID-19 test came back positive but no pneumonia on imaging.  Patient was evaluated by Physical therapy who recommended skilled nursing placement.  While waiting for insurance approval patient continued to make improvement and was able to walk with a walker with no issues. He requested to discharge home instead with physical therapy and occupational therapy at home. Physical therapy was agreeable with this plan and requested a walker for patient. Today patient has stable vital signs and denies any discomfort.  His CK level is down to 300s and he reports improvement on his symptoms.  Patient is being discharged home with visiting nurses with RN/PT/OT. I answered his question and address all of his concerns
Felt dizzy 1 minute later after vaccine; received water, juice. BP - 140/59.
Pt called pharmacy on 10-7-13 stating arm still sore from flu shot she received on 9-19-13. Rph explained muscle soreness normal, pt stated she may need to see her doctor.
This case was reported by a pharmacist via call center representative and described the occurrence of hypoglycemia in a adult female patient who received SHINGRIX. Concurrent medical conditions included diabetes mellitus. On 30th April 2018, the patient received the 1st dose of SHINGRIX. On 30th April 2018, several hours after receiving SHINGRIX, the patient experienced hypoglycemia. On an unknown date, the outcome of the hypoglycemia was unknown. It was unknown if the reporter considered the hypoglycemia to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was recently on a dietary change, starting a Nutrisystem program approximately 2 weeks prior to the vaccine administration. On 30th April 2018, the patient was vaccinated with the 1st dose of SHINGRIX in the mid-afternoon. On the same evening of vaccination at bedtime, the patient reported a blood glucose reading of 45 and took orange juice to bring the blood glucose level to normal. On 1st May 2018, following day after vaccination the patient showed blood glucose level as 70.
Pt was admitted from 4/7-4/8 for c/o bloody diarrhea and nausea for 1 week associated with fevers. Her hgb remained stable and she was discharged to follow up with GI on 4/8 with diarrhea resoled. CT scan at that time showed no acute abnl and minor sigmoid diverticulosis. She returned  on 6/9 with 4 days of bloody stool.  she was discharged on 6/16/21 after a protracted hospital course . Patient is a 67-year-old female with a past medical history significant for wheelchair-bound status secondary to MS and multiple left lower extremity surgeries, type 2 diabetes, CHF, hypertension, hyperlipidemia, depression, GERD who presented to the emergency room on 6/9/2021 for evaluation of bright red blood per rectum x4 days.  She was recently admitted in April for a day and a half for diarrhea that was bloody but symptoms resolved.  In the ER she was tachycardic and hypotensive she also had lactic acidosis.  She was ultimately admitted for anemia of acute blood loss, symptomatic hypotension and lower GI bleed as well as SIRS without sepsis.  She was seen in consultation by Gastroenterology and ultimately underwent a colonoscopy on 6/11/2021 which revealed no source for the bleeding and there was no evidence of malignancy she did have diverticulosis seen.  She had red-tinged stool throughout the ascending transverse descending and sigmoid colon as well as red bloody stool in the rectum.  She was on no blood thinners prior to arrival it stated in her med rec that she was on aspirin but she was not taking aspirin.  She remained in the hospital for close monitoring she did receive 2 units of blood.  We were hoping to advance her diet and plan discharge home but unfortunately patient began bleeding again and underwent a second colonoscopy on 6/14/2021 which again revealed the same bloody stool in the transverse, descending, sigmoid and rectum.  Patient did have a tagged bleeding scan which revealed evidence of bleeding with the tracer becoming visible in the region of the splenic flexure of the colon passing proximally and distally within the lumen of the colon.  Despite the second colonoscopy the bleeding source could not be found.  Patient was given an additional unit of blood.  She was monitored further.  She had a period of time after the colonoscopy where she had severe generalized abdominal pain but this resolved by the following day where she then began to have diarrhea but no further hematochezia or bleeding was noted. she was discharged on 6/16/21 home.   Of note this is the patient's fourth ER visit and or hospitalization since receiving her COVID-19 vaccinations.   CT showing no acute abnl and again diverticulosis. She received her 1st moderna covid 19 vaccine on 3/9  and her second on 4/9/21. she has had 2 hospitalizations since her vaccinations and 2 er visits 3/13 at another er noting increased blood sugars, blurred vision and a headache since her covid vaccine on 3/9 and 3/18 for fatigue, high blood sugars
Information has been downloaded from database (US-SEQIRUS-201802757). Information has been received from a physician concerning to a female patient (child). Concurrent conditions included asthma. Medical history was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot number and expiration date not reported), intramuscularly, for papilloma viral infection. Secondary suspects included doses of meningococcal vaccine, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and influenza virus vaccine for an unknown indication (strength, route, dosage schedule, lot number and expiration date were not reported). Immediately post-injection the patient experienced generalized tonic-clonic seizure (GTCS), an unspecified period after vaccination with influenza virus vaccine, meningococcal vaccine, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and GARDASIL 9. It was reported that the event GTCS met level 4 of Brighton collaboration diagnostic criteria, therefore the events were considered medically significant. At the time of the report the patient had recovered from tonic clonic movements, seizure, generalized tonic-clonic seizure and immediate post-injection reaction. The relationship between the aforementioned events and suspected therapies was not reported.
Patient received two doses of J&J and got a dose of bivalent Pfizer as a booster dose. Within  24 hours of receiving this vaccine, patient reports onset of congestion in his head that is affecting his hearing as well as congestion in his throat and chest. He reports mucous/phlegm and loss of voice. No fever development. Symptoms present 5 days post-vaccine.
adolescent patient received an adult dose of Havrix; adolescent patient received an adult dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a adolescent male patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: adolescent patient received an adult dose of Havrix) and inappropriate age at vaccine administration (Verbatim: adolescent patient received an adult dose of Havrix). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date 14 Jul 2023 The pharmacist reported an adolescent patient received an adult dose of Havrix.  The reporter did not consent to follow-up.  The pharmacist reported an adolescent patient received an adult dose of Havrix which led to overdose and inappropriate age at vaccine administration.
patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Hypertension, Cholesterol, Depression and Anxiety.    On 04-Oct-2022 at 9:25 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Oct-2022 at 9:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    It was unknown if the patient had ever been diagnosed or tested positive for Covid-19. Acute illness at the time of vaccination and up to one month before was unknown.  No concomitant medication was reported.  It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   No treatment information was provided.
Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   On 12th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. After vaccination, the patient developed are of redness about 100mm at the injection site, then shortly after that, the patient developed a 2cm area of redness below the injection site area that smaller in size with another area of redness 2cm below that one. The reporter reported that, the areas of redness were aligned down the patient's arm. The reporter consented to follow up.
due to Covid-19 situation / not vaccinated with the 2nd dose yet; This case was reported by a physician via call center representative and described the occurrence of social problem in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago, batch number 4N2AB, expiry date 10th February 2023).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age vaccination was not applicable for this report. The patient did not receive 2nd dose due to Covid-19 situation. The reporter did not consent to follow up.