chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cardiomyopathy; Shortness of breath (SOB) at night; This case was reported by a consumer via call center representative and described the occurrence of cardiomyopathy in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix. In September 2022, 2 months after receiving Shingrix, the patient experienced cardiomyopathy (serious criteria GSK medically significant). On an unknown date, the patient experienced shortness of breath. In January 2023, the outcome of the cardiomyopathy was recovered/resolved. On an unknown date, the outcome of the shortness of breath was unknown.   The reporter considered the cardiomyopathy and shortness of breath to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comments: The patient had stated that, he had received the first dose of Shingrix on 6 July 2022, in the left arm. He had not received second dose of Shingrix, on advisement of their cardiologist. The patient had reported of being diagnosed with cardiomyopathy approximately 2 months after receiving first Shingrix dose, in early September of 2022.  The patient had reported that the cardiologist was not able to confirm a link between the Shingrix vaccine and the cardiomyopathy, but was suspicious due to the timing and patient being very fit and healthy, with no previous cardiovascular concerns.  The patient had experienced Shortness of breath (SOB) at night, which had  led to seeking of treatment and being diagnosed with cardiomyopathy via echocardiogram. The patient had reported confirming resolution of cardiomyopathy via echocardiogram last week, after reduction of their physical activities/exercise for 3 months per advisement of cardiologist.  The reporter had consented to follow-up.
Patient described fever and fatigue 24 hours after vaccination. Upon going to get her flu shot about 2 weeks after she noticed a goose egg type ball near the site of the injection. From my memory when vaccinating the goose egg  was already present on the arm before vaccination but worth noting.  The patient did not report any redness or noticeable swelling post vaccination and it wasnt until the next vaccine that it was noticed.
Patient's daughter called on 9/8/18 reporting patient had a large rash at the injection site on left arm. I asked if the rash was larger than the palm of her hand and daughter stated it was. Advised pt to put an ice pak on the rash and to monitor it and if the rash continues to grow to call her Dr.
The first 3 days I simply had a sore arm. Since then I have had what I call a swimmy head. I get a headache w/ sometimes stabbing pains, and I feel like my head is full of water sloshing around accompanied by motion sickness and nausea.
fever.  PT presents with fever, bodyaches, nausea and chills with chest tightness and SOB x 11pm. reports received JJ vaccine 1700 yesterday. covid positive May 2020.
A consumer report has been received. The report concerns a 6 year old. Male consumer, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 05-Nov-2013. The patient experienced fever and vomiting which started on 06-Nov-2013. FLUMIST (Intranasal) was discontinued on 05-Nov-2013. At the time of reporting, the event of fever and vomiting was ongoing. The report was considered to be non-serious.
booster; a symptom of breast soreness; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing), notes: She compares it to PMS symptom even though she is "well past menopause". The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; BREAST PAIN (non-serious), outcome "unknown", described as "a symptom of breast soreness".  The lot number for bnt162b2 was not provided and will be requested during follow up..
Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization.  Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.
Severe sensitivity to flu or pneumococcal vaccine; Open heart surgery last summer (2019); The patient "felt like his head would explode , was nauseated and was miserable"; Severe headache; The patient fever goes to 104 degrees Fahrenheit; The patient "felt like his head would explode , was nauseated and was miserable"; This spontaneous report was received from a reporter referring to her husband, a male patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On multiple unspecified dates, the patient had received flu vaccine influenza virus vaccine unspecified (manufacturer unknown) or Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and had developed severe sensitivity to them.   On 15-JUN-2012 (reported as the most recent vaccination date), the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dosage, route of administration, lot #, expiration date, frequency not reported) and within 2 hours after being vaccinated the patient fever went to 104° degrees F and he experienced a severe headache. The patient felt like his head would explode and miserable (feeling abnormal) and was nauseated. The reporter mentioned that those symptoms lasted for 12 hours and then went out of it on the next day (16-JUN-2012).  On an unspecified date during summer of 2019, the patient had an open-heart surgery, however, additional information regarding this event was not provided.  The outcome for the open heart surgery was not reported.   The causality between flu vaccine influenza virus vaccine unspecified (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)  and pyrexia, headache, nauseam feeling abnormal and cardiac operation was not reported.   Upon internal reviewopen heart surgery was considered as medically significant event.
Client complained of nausea/emesis, teeth chattering, lethargy and difficulty breathing.  MD on site ordered epinephrine IM.  EMS called. Transferred to Emergency Room via EMS.
Grand Mal Seizure lasting 3 to 4 minutes. Ambulance ride to nearest hospital, given Ativan and received CT head scan, result negative.  Instructed to follow up with neurologist.
Hives all over my body; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 13Mar2021 13:30 (at the age of 33-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient previously took tylenol and experienced drug hypersensitivity. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 16:00, the patient experienced hives all over my body as resulted in emergency room visit and was treated with benadryl. It started 3/4 hours after the vaccine and it has carried on over the next two days. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Took my second dosage on 11/19/21, experienced some flu like symptoms and a low grade temp of 99 on 11/20/21, felt fine 11/21/21 and woke up at 3:30 AM on 11/22/21 with severe pain in by rib cage, chest, and upper abdomen. Went to the emergency room that morning, got tired of waiting to be seen after waiting three hours and went home. Went to Urgent care where they checked by vitals and advised my blood pressure is high, recommended I go back to the emergency room. Went back around 10-11 AM in which they did an EKG, Blood work, CT Scan, and Chest X-ray on me. Blood work indicated that my D-Dimer was elevated and they did a CT Scan to check for bloodclots, but the CT scan came back negative.
Communication/verification processes breakdown,  Moderna vaccine provided to table which was designated as Pfizer.   12 year old client received Moderna instead of Pfizer. ;
administered expired daptacel to a patient yesterday, expiration date of the product was 11 MAR 2022, with no adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid non-serious case was received from other health professional.  This case involves a 4 month old male patient who was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel) yesterday, expiration date of the product was 11-mar-2022, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Mar-2022, the patient received a 0.5 ml dose once of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5706BA, expiry date: 11-Mar-2022) via intramuscular route in unknown administration site for immunisation.  It was reported that the patient was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine yesterday, expiration date of the product was 11-mar-2022, with no adverse event (expired product administered, latency: same day).   Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered expired daptacel to a patient yesterday, expiration date of the product was 11 MAR 2022, with no adverse event).  At time of reporting, the outcome was Unknown for the event administered expired daptacel to a patient yesterday, expiration date of the product was 11 mar 2022, with no adverse event.  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 guidelines. 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.
This spontaneous report received from a registered nurse referred to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
No adverse event; patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired).    Concomitant medication was not reported.  The patient was administered COVID-19 vaccine from a lot number that was expired. The patient has not reported any adverse reactions to this dose. No treatment medication was reported.
experienced left arm numbness after vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left arm numbness after vaccine on an unspecified date. The outcome of the event was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Member had systemic rash, concentrated mix of hives and pustules. Rash covered torso, bilateral upper extremities, and face/head. Member seen at ER; treated with Benadryl and released. No current complaints.
Unexperienced nursing student gave Pfizer vaccine to Moderna patient; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Unexperienced nursing student gave Pfizer vaccine to Moderna patient) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Unexperienced nursing student gave Pfizer vaccine to Moderna patient). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Unexperienced nursing student gave Pfizer vaccine to Moderna patient) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Optic neuritis was diagnosed. Right eye pain and head ache began on 11Sep2021 and persisted. Right vision became blurry on 22Sep2021.
Patient passed out.  Head tilted forward, then back.  Muscles seized for a second then relaxed and patient came to.  Entire duration approx. 30 seconds.  Patient states had a rush of thoughts and was confused on what happened.  Had some slightly blurred vision and tinnitus for a few minutes.  Was feeling better within 10-15 minutes.
Child began coughing uncontrollably with some facial color change, circumoral cyanosis and red blotches on chest and back. PCP made aware/positive breath sounds auscultated. BENADRYL 2.5 ml given (12-5mg/5ml) symptoms resolved.
Information has been received from a physician concerning a 9 year old male who in approximately 1999 was vaccinated with a 0.5 mL SC dose of varicella virus vaccine live (Oka/Merck) (Lot number not provided) a 1 year of age. Subsequently, the patient developed breakthrough chickenpox with 50 to 100 lesions. Unspecified medical attention was sought. The patient was noted as "doing better." No product quality complaint reported. Additional information has been requested.
Severe body aches and pressure on my body; Severe body aches and pressure on my body; Muscle pain in the chest and in the upper back in the shoulders; Having a lot of trouble being able to talk; really hurts my chest; This is a spontaneous report from contactable consumer. This consumer (patient) reported that:  A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0153) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced severe body aches and pressure on my body, muscle pain in the chest and in the upper back in the shoulders, having a lot of trouble being able to talk and really hurts my chest. The patient received first dose Pfizer Covid-19 Vaccine on Monday about 4-5 days ago 16:15 in the afternoon. The patient was still experiencing severe body aches and pressure on body, muscle pain in the shoulders and in the chest and especially in the upper back in the shoulders and in the chest and was wondering if that was normal for 5 days away. The patient was having a lot of trouble being able to talk. It really hurts the patient's chest. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.   No Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a registered nurse, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses M-M-R II with lot # M036544 and expiration date on 15-AUG-2018 (strength, dose, route of administration or anatomical location were not reported), reconstituted with an also improperly stored sterile diluent (manufacturer unknown) with lot # L025375 and expiration date on 14-MAR-2018; both administered for prophylaxis. The storage temperature was 9 to 25 degrees Celsius (°C) (9.8 °C), for a timeframe of 20 minutes and 9 to 25 °C (8.5 °C) for 7 minutes. There was previous temperature excursion at 9 to 25 °C for 3.31 hours. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA013515: US-009507513-1709USA015078.
Projectile vomiting after nursing for 3 weeks post vaccination, pediatric progress note states post viral dysmotility
Patient fainted after receiving vaccine, she required a fan and needed to sit for an hour after dose.  She could breath fine, but felt light headed.  She had this reaction within 5 minutes of the immunization.
A spontaneous report was received from a healthcare professional concerning a 77-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever 100.6, bodyaches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) fever 100.6 . On 12 Feb 2021, the patient experienced the event(s) bodyaches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever 100.6 was unknown.The outcome of event(s), bodyaches was unknown..
Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 042L20A) for COVID-19 vaccination.     The patient had no allergy.  The patient's past medical history included Balance difficulty. Previously administered products included for Product used for unknown indication: Flu shot (Other vaccine given within 1 month to COVID-19 vaccination). Past adverse reactions to the above products included No adverse event with Flu shot.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022). At the time of the report, COVID-19 (Tested positive for COVID/ Had COVID after two week sof first dose/ Again COVID on April-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive. In April 2022, SARS-CoV-2 test: (Positive) Positive.         The height was 176.7 cm (5feet 8 inch). The concomitant medication was not provided. The anatomical location was deltoid shoulder. The patient was COVID-19 positive again on Apr-2022. Treatment medication was not reported.   This case was linked to MOD-2022-658053, MOD-2022-658052 (Patient Link).
Patient reported feeling lightheaded a few minutes after vaccine was administered. Also became hot and clammy. BP taken x 2, and noted to be hypertensive at 182/118. Supervisor and local paramedics notified. 12 lead EKG performed by arriving paramedics, as well as a blood sugar; which was 172. Patient decided to seek additional medical attention and local hospital.
Provider d/c note:  "84-year-old home resident who presented to the ED for the second time in 10 days after a ground level fall at her assisted-living facility.  Also COVID positive.   Injuries included: 1. Left subdural hematoma, 5 mm.  Met BIG 2 critieria. **Repeat head CT stable on 8/25/22 2. Non-displaced right skull fracture 3. Posterior right 3-4 rib fx, likely an old injury   Other medical issues: 1. Frequent falls, spanning back several years according to chart review.  Has had extensive work-up by outpatient neurology. 2. COVID positive, asymptomatic  3. Hypokalemia, replaced 4. Right shoulder pain, with evidence of previous injury (ecchymosis, painful ROM)     PT/OT evaluated the patient and SNF advised.  PT and the surgical team both spoke with the patient's son. He prefers for his mother to return to her assisted-living facility.     Issues Requiring Follow Up:  Neurosurgery follow-up 9/7/22 with Dr.  Repeat head CT.             **Hold ASA and NSAIDs per BIG guidelines, until cleared to resume by neurosurgery Neurology follow-up with Dr., as arranged May follow up with trauma surgery as needed"