chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9265), on 06Mar2021 as dose 2, single (Lot number: EN6205), on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; LOSARTAN; PAXIL [PAROXETINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Positive, notes: positive with antigen test; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Positive, notes: still positive; (02Sep2022) Positive, notes: positive pcr test for Covid 19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medication in 2weeks. Took paxlovid Sept 2-6 upon positive pcr test for Covid 19 Sept 2 Symptoms much improved. 3 negative tests. Symptoms returned worse and rebounded testing positive with antigen test on 11Sep still positive and symptoms starting to improve on 14Sep.
Unable to sleep that night, up and down all night long (Melatonin and tea did not help) Chills Fever Nausea Major Headache (took Acetaminophen and Ibuprofen but neither helped)
Had a hot flash or flushing sensation; Had a hot flash or flushing sensation; Tingles and a decreased sensation around her lips/numbness and a tingling to her lips and nose; Numbness and a tingling to her lips and nose; This is a spontaneous report from a contactable nurse. A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular (left arm) from 14Jan2021 16:30 to 14Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that 10 minutes after the injection, she had a hot flash or flushing sensation, as well as numbness and a tingling to her lips and nose. She explained having "tingles and a decreased sensation around her lips", which she also referred to as a "diminished sensation" during the interaction. She says that she has done no treatment for this. The outcome of the events was unknown.
The day after the vaccine I had a problem with one of my eyes and then the other. It was similar to ocular migraine symptoms. I then started to have stroke like symptoms. I looked at my friends and stated that I did not know their names. I went to a walk-in clinic and then I was hospitalized for three days. My blood pressure was extremely high. All of the tests were negative for stroke and I have worn a Holter monitor. I also had Neurology, Cardiologist consult and many different medications. I have stopped taking all of those medications. I have not had any more symptoms like that since that day and it only lasted less than 15 minutes.
Complained of skin feeling hot and "on fire" after receiving flu shot.  No fever.  Was out-of-town, so self-treated with Benadryl, which helped.  Lasted approximately 2 days.  After burning sensation went away, skin felt tender to touch.
4CM REDNESS WITH SWELLING AT THE SIGHT OF THE INJECTION WITHIN 20 MINUTES OF ADMINISTRATION.  ADMINISTERED 10CC OF CHILDREN'S BENADRYL ALLERGY FOR HER WEIGHT.  CAREGIVER WILL REPEAT AS NEEDED Q6H AND GIVE IBUPROFEN IF NEEDED.  MAY APPLY ICE FOR COMFORT.
Right shoulder to halfway down arm was reddened, edematous, painful around whole arm and was warm to touch. Ice applied. Vicodin, 2 administered hs-unable to sleep. Informed client to continue ice and she takes aspirin and to call MD. MD's nurse states to continue with ice and pain medication. On 10/5/00, right arm had no soreness, edema or redness.
Injection area on right thigh was red, swollen and hard. Instructed to apply ice pack. Called on 3/5/18 and the mother said the swelling went down. Just a small hard area Left, coloring looks like when a bruise starts to heal.
lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin; swollen lymph nodes in her neck; swollen lymph nodes in the armpit (underarm); This spontaneous case was reported by a patient and describes the occurrence of GROIN PAIN (lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin), LYMPHADENOPATHY (swollen lymph nodes in her neck) and LYMPHADENOPATHY (swollen lymph nodes in the armpit (underarm)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-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 GROIN PAIN (lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin) and LYMPHADENOPATHY (swollen lymph nodes in the armpit (underarm)). an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in her neck). At the time of the report, GROIN PAIN (lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes in her neck) and LYMPHADENOPATHY (swollen lymph nodes in the armpit (underarm)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. No treatment details were provided. Patient experienced the lower left groin pain on the side of the shot after around 8 weeks of shot. Doctor thought that it was hernia, She had to go again to check it's not ovarian related as she still experiencing soreness.   This case was linked to MOD-2021-065389 (Patient Link).
Started getting a blurry circle in my vision around 11am. It kept bothering me. I kept closing my eye and thinking it was just something bright I looked at that made the circle appear, but then I couldn?t really see and there was a white line that snaked around and started strobing a few different colors and my eye felt lazy and heavy. This lasted around 25-30 minutes. I have never experienced this before in my life and really freaked me out thinking I had a stroke, but could walk and talk fine and
hard dime sized lump that is tender to palpation, lump is still there as of today (day 11 after her vaccination)
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# M022077 and expiry date 10-MAR-2019) (lot# L048848 and expiry date 09-AUG-2018) (lot# M020926 and expiry date 11-AUG-2018) (lot# M008551 and expiry date 02-JUN-2018) (lot# M011838 and expiry date 09-AUG-2018) (lot# M029233 and expiry date 09-AUG-2018) (lot# M032649 and expiration date 11-NOV-2018) and (lot# L030608 and expiration date 15-APR-2018) intramuscularly (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Interchange of vaccine products; Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 081B21A and 048B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Overweight (just overweight and over 50) and Drug allergy (Unknown drug allergy).   On 26-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021 at 12:00 PM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COVID-19 (Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive again. On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative on day 9 and positive (Positive) took paxlovid on first day of covid test and symptoms.         No Concomitant medication was reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The device date was reported as 23-May-2022.  Patient took paxlovid on first day of covid test and symptoms, and tested negative on day 9 and felt fineday 11 started feeling like patient had a head cold, and tired, today patient tested and is positive again.  No treatment medication was reported.
A few days post vax, the pt developed a red, non-raised itchy rash on the right side of the neck and anterior chest. No treatment was given. Engerix B was discontinued. Symptoms resolved in 7-10 days.  The most recent information received reports the outcome of the event as resolved.
After administration of vaccine, we were notified by clinic that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  Patient returned on 10/13/2022 for revaccination.
Hodgkin's Lymphoma symptoms began in April 2010. Diagnosed August 6th, 2010.
patient received the fluzone quad but he was supposed to get the fluzone HD with no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received the Influenza quadrival A-B vaccine [Fluzone Quadrivalent]but he was supposed to get the Fluzone HD with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza quadrival A-B vaccine, suspension for injection (dose, strength, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination but he was supposed to get the Fluzone HD with no reported adverse event (wrong product administered) (unknown latency).  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
ADMITTED 11072021: Chief Complaint Fever, cough, sob  History of Present Illness  53 year old female known with past medical history of NSCLC, COPD, DM2, HLD, IDA, & depression/anxiety, admitted through ED with complaints of fever of 103 at home, cough, sob. COVID+ , despite vaccinations. ABG with PO2 of 60.  She is followed for metastatic NSCLC. S/p Carbo/Alimta/Keytruda C2 on 10/26/21. We have been asked to admit and will consult hospitalist for COVID management.   DISCHARGED: 11082021: Hospital Course: COVID PNA, Fever, Hypoxia - COVID+ in ED 11/7.  - consulted hospitalist for assistance with management of COVID, received remdesivir with iv dex: Would complete 10 days Dexamethasone, Could consider Regeneron as outpatient soon after dc, but needs booster and would have to wait 90 days d/w HOG team, patient can discharge today, procalcitonin <0.25 serially no unlikely to need antimirobials.   - blood cultures/ UA negative.  - rocephin/doxy started in ED- D1 11/7. Discontinued at discharge.  - supplemental O2 prn, discharged on room air.  - duonebs, formoterol, budesonide, discharged to home and will continue on prior to admission inhalers.
Patient received injection on the left arm. Later that evening the patient reported increased respirations, heightened anxiety and pain in the left arm. The patient did state he took a hydrocodone and a nitroglycerin tablet prior to bed. During the night the patient woke up and stumbled around, hit his head and reported "blacking out and doesn't remember" after that. The patients wife and son helped him to regain consiousness and they transported him to the hospital. Patient stated he spent 3 days in the hospital. He brought it to the attention of the pharmacy on the morning of March 22, 2022.
"Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented with dyspnea after recent travel. Found to have covid, but due to multisystem atrophy concern for aspiration also had. She developed worsened stridor and secretions, was intubated, soon thereafter extubated to HFNC but weaned very quickly. Treated with steroids, antibiotics, returned to baseline. Husband eager to get her home, well versed in her medical care and comfortable taking care of her. Speech therapy worked with her recommending a level 3 nectar thick no straw diet. Thickener provided.   BP (!) 132/95  | Pulse 85  | Temp 36.6 °C (97.8 °F) (Axillary)  | Resp 18  | Ht 1.575 m (5' 2")  | Wt 61.2 kg (134 lb 14.7 oz)  | LMP 06/02/2015  | SpO2 99%  | BMI 24.68 kg/m²    General: in NAD, non toxic Right ear with significant ear wax cannot visualize ear drum. Respiratory: no respiratory distress. Coarse. No stridor or wheeze. CV: regular rhythm, normal rate ABD: soft, non-tender  Neuro: alert. Does not speak but can mouth-words.   Telemetry: normal sinus rhythm   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned.     Issues Requiring Follow Up: (Who, what, when, and how communicated?) speech therapy reevaluation of swallow ability"
This spontaneous report as received from a 63 year old female consumer refers to herself. The patient had no pertinent medical history and no drug allergies. Concomitant therapies included levothyroxine (manufacturer unknown) and acyclovir. On 28-JUL-2016,the patient was vaccinated with ZOSTAVAX (single vaccine injection, subcutaneously, lot # not reported), because her friends had advised her, as too many people were getting shingles. Two days later, on 30-JUL-2016, the patient began experiencing a rather large itchy rash at the injection site. The patient also stated that the rash was at times itchy. The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. The rash had not spread elsewhere at the time of this report. The outcome of the rash was reported as not recovered. Additional information is not expected because the patient refused to provide her physician's contact information.
COVID-19 MODERNA booster was administered too early today 12/28/21. Failed to verify  vaccine card prior to administering COVID-19 booster. Patient was observed after receiving the vaccine and no adverse reaction was recorded. Error was noted during documentation and after verifying  Error was reported to RN and leadership. Patient was contacted and did not report any adverse reaction. Patient was not aware of booster regulation or which COVID-19 vaccines she received prior to the booster. Patient was made aware to report any adverse reaction to clinic staff.
COVID-19 Pneumonia; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 Pneumonia) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 1:40 PM, 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 COVID-19 PNEUMONIA (COVID-19 Pneumonia) (seriousness criteria death and medically significant). The patient died on 19-Aug-2021. The reported cause of death was COVID-19 pneumonia. It is unknown if an autopsy was performed.             Concomitant Medication use information was not provided by reporter. It was reported that the patient died after 6 months of receiving vaccine and manner was reported as natural. Treatment Medication use information was not provided by reporter. Company comment-This spontaneous case concerns a male patient aged 79 years with no medical history reported, who experienced unexpected serious fatal and (medically Significant) event of COVID-19 Pneumonia on an unknown date after receiving second dose of mRNA-1273 vaccine. Patient had received first and second dose of mRNA-1273 at an interval of 1 month. There was no information provided about the underlying medical conditions, concomitant medications, associated symptoms, diagnostic and treatment details, clinical course of the event leading to the fatal outcome. Patient died about 5 months 7 days after vaccination. It is not known if an autopsy was performed. The manner of death was reported as natural and underlying cause of death reported as covid-19 pneumonia. The event Covid-19 Pneumonia might be explained by current pandemic outbreak and elderly age could be a risk factor. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   This case was linked to MOD-2023-723358 (Linked Report).; Sender's Comments:  MOD-2023-723358: Mother's case; Reported Cause(s) of Death: COVID-19 Pneumonia
On the first day I was really tired with arm pain and by the third day I noticed swelling on my shoulder/neck. I went to the doctor on 3/8 and she said I had enlarged laponites and is likely related to the vaccine. No medications was prescribed and told me to follow up within a few weeks.
sore at the injection site; tender at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE PAIN (tender at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included PARACETAMOL (TYLENOL), LEVOTHYROXINE SODIUM (SYNTHROID), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE PAIN (tender at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE PAIN (tender at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
June 1-6:  symptoms of pericarditis (chest pain, heaviness, shallow breathing, pain when lying down) Ongoing: heart palpitations
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:173 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine: 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
pt recv vax 16OCT96 & 18OCT96 3AM pt awoke w/achy joints until 23OCT96 denies any other c/o;