chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 82 y.o. M with PMH including  CAD status post CABG, GERD, HTN, OSA, status post AICD, GAD, obesity, type 2 diabetes, CKD3, TIA, Afib on anticoagulation and amiodarine, AS s/p TAVR, HLD, CHF, PMR, AAA, and PAD s/p carotid endarterectomy who presented to the ED with SOB and hypoxia. Patient admitted as inpatient on 6/16 due to COVID-19 pneumonia acute hypoxic respiratory failure. Patient was tested for COVID-19 and was positive on 6/16.
I am experiencing menstrual cramps and spotting, when it's not time for my menstrual cycle. I will be starting my period very early. I was told to report these symptoms since many other women are experiencing changes in their menstrual cycle too.
Fever, Shiver, Muscle pain, Redness swelling at injection site (Symptoms started on Tuesday eve through Wed and even on Thursday night)
asked for clarification and the patient became confused; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "asked for clarification and the patient became confused". Additional information: the patient received his first covid vaccine on 21Mar2021. When asked for clarification the patient became confused. The patient was told that the 21st was two days from now and that he may have received his first covid vaccine on the 21Feb instead which he would be two weeks over his 21 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6/21/2022 - Adverse Event was a bad sore throat  6/22/2022 - Very bad sore throat and swollen glands in throat -  got progressively worse quickly that afternoon 6/23/2022  - went to  (to the Emergency Room); temperature was 98.4; ER Doctor did a full blood workup, Strep Test, Chest X-Ray and PCR Covid test. ER Dr. told  was positive for Covid; He prescribed Paxlovid. I received my Rx for Paxlovid at the Pharmacy
Saturday Night my tongue started swelling in the middle and edges of my tongue 5-6 days.  Sunday and Monday started to itch
received a dose of Shingrix that had expired on 26/Aug/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (batch number Z42G4, expiry date 26-AUG-2023) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Shingrix. On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: received a dose of Shingrix that had expired on 26/Aug/2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-Oct-2023 The reporter consented to follow-up. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Dizziness, vomiting, felt Gross, Passed out for around 10 seconds, and was making strange noises with some difficulty breathing. Body stiffness. Applied wet towels with cold water on the nape and forehead
On 05/24/02 pt woke up and noticed swollen hands and arms and small "mosquito bites," which were "itching really bad." Later in the day, pt noticed her lips were swelling and hives had become much larger. Went to ER where she was given "a teroid" shot and Benadryl. Hives, swelling and itching resolved after these treatments.
no adverse effect; four month old patient was inadvertantly administered a dose of VAQTA; four month old patient was inadvertantly administered a dose of VAQTA; This spontaneous report was received from a nurse and refers to a 4-month-old patient of an unknown gender. The patient's past medical history, concomitant medications and drug reaction or allergies were not provided.  On 18-SEP-2019, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, formulation, route of administration were not reported; lot # S007770 with expiration date 24-JUL-2020) of for prophylaxis. The nurse reported that the patient was supposed to be administered a dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). No adverse effects were reported. The outcome of product administered to patient of inappropriate age, no adverse event and wrong vaccine administered were not reported.
CHIEF COMPLAINT:   patient BIBA with C/O increased SOB starting about a week ago. patient states he has not felt well since discharge from hospital with diagnosis of pneumonia in november. patient was 82% on RA.   HISTORY OF PRESENT ILLNESS:     83 yo male with PMH of GERD/CVA/CHFCOPD/CKD/HTN/HLD and other medical issues as below came to ED due to c/o progressively worsening SOB and productive cough for 1 week. No cp/dizziness/palpitations/fever/chills. He had recent admission for PNA. He was hypoxic in ED. Chest xray was negative.  He is covid positive. He got in steroids and remdesevir.
approx 5 days p/vax pt exp 8 lesions on trunk. 4/2/99 pt had 25 lesions, 4/5/99 all lesions crusted over.
This spontaneous report as received from a certified medical assistant refers to a 32-year-old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications were reported. On 24-FEB-2016, the patient was accidentally vaccinated with a dose of PROQUAD (Merck) subcutaneously (dose, lot #, expiry date and anatomical location were not specified). On the same date, the patient received also a dose of VARIVAX (Merck) subcutaneously (dose, lot #, expiry date and anatomical location were not reported). It was reported that the vaccines were administered in "different locations". No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
fever; sharp Pain; heavy arm (can not move nor touch at all); heavy arm/ arm discomfort; swelling of the throat; couldnt sleep; difficulty breathing, shallow and fact, need to sit up to breath; Weaken arm, dropped dishes many times; fast heartbeat; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain, mobility decreased, heaviness in arm, throat swelling, insomnia, difficulty breathing, weakness of arms and heartbeats increased. The patient was treated with budesonide + formoterol (Symbicort Turbuhaler) and other anti-asthmatics, inhalants (Asthma Inhaler (Nos)). On an unknown date, the outcome of the fever, pain, mobility decreased, heaviness in arm and insomnia were unknown and the outcome of the throat swelling, difficulty breathing, weakness of arms and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the fever, pain, mobility decreased, heaviness in arm, throat swelling, insomnia, difficulty breathing, weakness of arms and heartbeats increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The patient self-reported this case  The patient got 1st Shingrix shot on 14th March (year unspecified). The patient was wondering whether to take 2nd shot or not as he/she had strong side effects after 1st shot, beside fever. The patient got Shingrix shot at 10:45 am and in afternoon the patient had sharp pain and heavy arm (could not move nor touch at all) swelling of the throat (the patient took Symbicort Turbuhaler, asthma inhaler, then it became okay)  At night the patient could not sleep due to difficulty breathing (shallow and fact breathing) and need to sit up to breath fast heartbeat. Next morning no more difficult on breathing and heartbeat was normal. The patient experienced weaken arm (dropped dishes many times) for more than one month. The patient experienced pain, mobility decreased, heaviness in arm and insomnia, throat swelling, difficulty breathing less than day after receiving Shingrix.  The patient asked would please give him/her advise, whether he/she should take 2nd shot or not.
Limping in the morning.  Mostly with the left leg, occasionally with the right.  Blood work on 3 occasions normal, fluid shows on ultrasound of left hip and some on right, xray normal, cold symptoms appeared on 12/16 with low grade fever runny nose.  Hip still hurts after 12 days.
About 48 hours after receiving 2nd HPV vaccine, broke out with urticarial rash on legs and arms.
Anxiety; hands and toes and bottom on feet are feeling numb/fingertips felt a little numb/numbness in the right side of face; heart palpitations; low heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (low heart rate), HYPOAESTHESIA (hands and toes and bottom on feet are feeling numb/fingertips felt a little numb/numbness in the right side of face), PALPITATIONS (heart palpitations) and ANXIETY (Anxiety) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ventricular septal defect. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and FLUTICASONE PROPIONATE for Allergy.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced BRADYCARDIA (low heart rate) and PALPITATIONS (heart palpitations). On 20-Apr-2021, the patient experienced HYPOAESTHESIA (hands and toes and bottom on feet are feeling numb/fingertips felt a little numb/numbness in the right side of face). On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, BRADYCARDIA (low heart rate), HYPOAESTHESIA (hands and toes and bottom on feet are feeling numb/fingertips felt a little numb/numbness in the right side of face), PALPITATIONS (heart palpitations) and ANXIETY (Anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Evening of vaccination developed fever, headache, pain, redness, and large swelling at injection site on the left arm. Arm was swollen from shoulder to elbow. Also received flu vaccine in right arm. Patient states symptoms started to resolve by 10/06/2010.
Arm Pain at the Injection Site which seems to be lessening somewhat; Chills; Fatigue/Tiredness; Slight headache; My body feels heavy, as if I am carrying a weight, but no muscle pain; Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, MANUFACTURER UNKNOWN, formulation: Solution for injection, Lot Number: not reported; Expiration Date: not reported), for covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovering", described as "Arm Pain at the Injection Site which seems to be lessening somewhat"; CHILLS (non-serious) with onset 18Mar2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Fatigue/Tiredness"; HEADACHE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Slight headache"; DISCOMFORT (non-serious) with onset 18Mar2021, outcome "unknown", described as "My body feels heavy, as if I am carrying a weight, but no muscle pain"; BODY TEMPERATURE FLUCTUATION (non-serious) with onset 18Mar2021, outcome "unknown", described as "Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that side effects, which began yesterday evening, to the COVID-19 Vaccine Pfizer-BioNTech, 2nd Dose, Lot#EL3247, Taken at (name), yesterday, 18Mar2021Arm Pain at the Injection Site which seems to be lessening somewhat, Chills, Fatigue/Tiredness, Slight headache, Patient body feels heavy, as carrying a weight, but no muscle pain. Temperature fluctuates, goes up and down 100.3, 99.4, 98.6, now it is at 100.9. Patient realize these are common reactions, but must be reported nonetheless.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse practitioner and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unspecified dates, improperly stored doses of VARIVAX (dosage and route administration were not provided; lot # M006157, expiry date 05-FEB-2018) were administered to the patients. The vaccines were stored in the temperature 8 degrees Fahrenheit for 1 hour and 25 minutes. There were previous temperature excursions over 6 degrees Fahrenheit but under 14 degrees Fahrenheit for 2 hours and 25 minutes and over 15 degrees Fahrenheit but under 46 degrees Fahrenheit for 17 hours and 50 minutes on unspecified dates. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA014480:
Redness at injection site. Very painful and hot to the touch. Recommended going to MD.
Approximately 11 hours after dosing, symptoms began including chills, muscle aches, and feeling feverish. Next morning, ibuprofen and ice pack administered for fever and headache which developed during the night. Fever dissipated by mid afternoon, minor body aches remained for twenty four hours, as did headache.
Red spots on stomach and upper front of body; This is a spontaneous report from a contactable consumer, the patient. A 53-year-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 in the left arm on 06Apr2021 at 12:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included high allergic reaction to poison Ivy exposure. The patient previously received paracetamol (TYLENOL) on an unspecified date for an unknown indication and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 (Thursday) at 05:00, the patient woke up with lots of red spots on stomach and upper front of body.  No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event red spots on stomach and upper front of body was recovering at the time for this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Several hrs after receiving vaccine, pt experienced swelling up to left shoulder and neck and axillary lymph node swelling. Also c/o numbness and tingling in left arm and hand. Slowly resolved over next 4 days. Treated with Ibuprofen and Allegra.
Per patient's mother, approximately 3 hours following administration of vaccines, the 2 mo old patient had witnessed stopped breathing. Prior to, the patient was completely well, afebrile. When seen in clinic that day, pt was well. Mother went to pick up baby who was limp and ashy colored. Upon running to neighbor, within minutes, baby perked up and breathed. 911 called and baby was brought to hospital where she was evaluated and admitted overnight for testing and observation. Chest Xray, brain ultrasound and EEG were all normal. Pt was diagnosed with having a suspected seizure due to administration of DTaP.
One of twenty-one cases: A non-serious spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Patient has a rash on her upper right arm, sore and painful.  Treatment: use a cold compress and take Tylenol for pain, she was offered a topical steroid but she denied.  Patient is to monitor site for worsening redness, swelling, itching or pain.
Tested positive for COVID-19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19 after 1st dose). At the time of the report, COVID-19 (Tested positive for COVID-19 after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with the lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 32 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
(08/01/2021) Mild Cold symptoms, loss of smell, Fatigue, ect. went to doc (08/02/2021) Got results for breakthru CovID on (08/04/2021)  Was released from  isolation on 08/14/2021.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Pt developed vesicle between nose and upper lip on the left side on 3/27 (vaccinated 2/26, scab fell off around 3/12).  Lesion broke, drained yellow fluid, was painful, about 1 cm.  No h/o HSV.  Seen by derm, likely pyoderma.  Vaccinia PCR NEGATIVE
4 hours after vaccines, child went limp, pale, dusky. No tonic/clonic movement, nothing to suggest seizure. Did routine mouth to mouth. 911 called. Child vomited about 20 minutes later. By 1 hour later child was back to normal. Watch overnight in hospital. No etiology was found.