chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Dizziness Weakness Narrative:  Reported weakness and dizzy. Evaluated by NP. VS taken initial - BP 156/91, HR 76, O2 sat 94% on RA. Continued monitor - BP 169/ , 162/88 O2sat 100% on RA. Lungs clear, no wheezing or SOB reported. Pt was able to hold conversation with nursing staff w/ no issues. Pt reports she took half a tablet of her HCTZ today and indicated she will follow up with her primary care MD regarding her elevated BP. Reports feeling better after resting. No signs of symptoms of distress noted @ 1230. Vitals BP 152/84 HR 69.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 4:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Feb-2022 at 4:05 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
Pt. received HPV 1 in (R) arm IM. Pt. C/O (R) arm pain after vaccine administered. Pt. then received FLULAVAL in (L) arm IM. Within 1-2 min after vaccines given pt. reported "not feeling good". Pt. proceeded to lay down in prone position with head, neck, shoulders stiff and elevated off table. Pt. was unresponsive to touch and calling her name. No cyanosis observed. Then pt. had seizure activity lasting 5-7 sec. Pt. BP 132/68 after seizure. Incontinence of urine occurred. Pt. arousable right after seizure. Gave pt. water, rest, PEDIALYTE popsicle. Within 15-20 min after seizure pt. BP 104/62.
Lump and pain where shot administered, swelling increased for more than two months, looks like a carbuncle but hasn't erupted yet.  Went to surgeon two weeks ago who said. It to worry about it, but it has continued to swell and gotten worse.  No fever accompanies it, but site is hot to touch.  Using warm compress presently.
. Received his first dose Pfizer (LOT#: EW0185 EXP: 8/2021) at 1013 on 5/18/21. Patient alerted EMT . Patient stated that he felt dizzy and felt like his ears got covered up. Patient stated that he had not had not eaten in the morning. EMT  took patients vital signs at 1110. BP: 100/50, pulse: 68, O2: 98%. Patient was given water, juice and food. Patient was placed in zero gravity chair. Patient was asked to stay an extra 30 minutes for further observation. EMT reassessed and re-took vital signs at 1050. BP: 120/76, pulse: 77, O2: 97%. Patient stated he was feeling better and felt no symptoms and was good to go. Patient was educated on worsening signs and symptoms of vaccine and when to seek EMS or urgent care. Patient verbalized understanding of education. Patient left vaccination site at 1100 unassisted and with a steady gait.
This spontaneous report was received from a registered nurse refers to a 4 month old female patient. No pertinent medical history was reported. On 22-APR-2015, the patient was vaccinated with ROTATEQ SUSPENSION 2  (lot# K022990 and expiration date 26-JUN-2016) 2 ml once, oral. On an unknown date, the patient mother reported that the patient vomited during the car ride home after receiving ROTATEQ. The patient mother was enquired whether the patient received a full dose of ROTATEQ and if the vaccine would still be efficacious because the patient vomited shortly after receiving it. Patient sought medical attention, patient mother called to the office. Treatment was not given to the patient. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. On 22-APR-2015, the outcome of event was reported as recovered/resolved. Causality was not assessed by the reporter.  This is one of the two reports from the same source. Additional information has been requested.
After client received her COVID-19 Pfizer vaccination, client was sitting in the observation area of the vaccine clinic (as required after receiving the vaccination) and it was observed by the EMS person and Public Health Nurse that was there, that client was itching her forearms.  Client had developed a red rash, starting on her arms and then her neck and chest (blotchy red).  She complained of itching on her arms, neck and then her head.  She reports she felt like she was "on a boat", feeling lightheaded.  Client was taken to the emergency room where client reports she received IV Benadryl.  Client reports that after being at the ER for 1.5 hours, her rash resolved and she no longer felt lightheaded.  Reports no other symptoms after that.
In October 2022, I began feeling fatigued and experienced muscle aches, weakness, and difficulty walking. On November 8, 2022, I had stomach cramps and visited Hospital, where I received antibiotics and was discharged.  On November 9, while at work, I noticed heaviness in my feet and worsening balance issues. The next day, November 10, my symptoms escalated, leading to a fall down the stairs. After another visit to Hospital, I was given medication but sent home.  On November 10, while trying to get into an car, I fell again, and I required assistance to enter the vehicle. Later that day, I collapsed while approaching my front door, and my family called an ambulance.  On November 11, 2022, I was transp
Delayed urticarial reaction to covid vaccine starting 11 days after the 1st injection.  Itchy,red area w/o tenderness. (+) dermatographia. Afebrile. Not bigger after 2 days but no smaller. Well reported but uncommon rxn that is self-limited. To call if it lasts >1 week, worsens, or if she has a fever.
Fully vaccinated with Three doses of Pfizer. Tested positive for COVID 19 on 01/28/2022. Admitted to hospital on 02/05/2022. Expired on 02/09/2022 while still hospitalized.
I63.9 ACUTE STROKE OF CEREBELLUM, UNSPECIFIED TYPE AND ARTERY 4/2/2023 ACUTE STROKE OF CEREBELLUM, UNSPECIFIED TYPE AND ARTERY
lightheadedness; significant warmth at injection site on right arm; Pain at injection site on right arm; swelling at injection site on right arm; all over body ache; Headache; fever less than=100 degree F; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm) and PYREXIA (fever less than=100 degree F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2018, Diabetes since 2019, Hypothyroidism since 2000, Acid reflux (oesophageal) since 2010, High cholesterol since 2015 and Allergy (colonoscopy preparation). Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes, SIMVASTATIN for High cholesterol, LOSARTAN for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism.   On 27-May-2021 at 8:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PYREXIA (fever less than=100 degree F). On 27-May-2021 at 2:00 PM, the patient experienced DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), MYALGIA (all over body ache) and HEADACHE (Headache). On 01-Jun-2021, DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), PYREXIA (fever less than=100 degree F), MYALGIA (all over body ache) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), PYREXIA (fever less than=100 degree F), MYALGIA (all over body ache) and HEADACHE (Headache) to have an unknown relationship.    Treatment information  was not provided.
Warm red indurated rash left deltoid stared 13d after immunization.  Didn?t see others had reported so figured I should.
Throbbing head ache had to sit in the dark from 3-8pm; No appetite; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (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: HEADACHE (non-serious), outcome "unknown", described as "Throbbing head ache had to sit in the dark from 3-8pm"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports dropping things out of her hands involuntarily post-vaccination, which is abnormal to her. She also reports getting confused as to where she is while driving, not knowing whether to turn right or left when heading home. Memory problems reported are out of the ordinary pt states.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. On 23-AUG-2011, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). A second dose of GARDASIL (Lot # not reported) (dose and route not reported) was administered to the patient on 22-AUG-2012 and the patient was currently at the physician's office and a third dose of GARDASIL (Lot # not reported) (dose and route not reported) will be administered that day on 27-AUG-2013. Concomitant therapy was not reported. No adverse symptoms reported.  Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of a 40 year old female subject who was vaccinated with Engerix-B for prophylaxis and has not responded to therapy. The subject's medical history, concurrent conditions and concurrent medications were not provided. On unspecified date the subject received two series of Engerix-B, dosing not provided. Lot numbers and expiration dates were not reported. Three dose of Engerix-B were administered per series. The subject was reportedly not responding to therapy. No additional information was provided. Follow up received on 09 June 2006 did not indicate that the subject experienced any adverse events after receiving Engerix-B.
Severe malaise and weakness followed by diarrhea 5x times daily for 2 days, poor appetite - dehydration. Felt feverish, temp not taken until visit 9/27/10 when feeling improved.
I have had a low-grade fever, fatigue, and experienced mild diarrhea throughout the day, but in the evening experienced more intense lower-abdominal cramping and then passed stool with a fair amount of bright red blood including purple/pink clumps of unknown substance (non-stool)
Site: Pain at Injection Site-Severe, Systemic: Bell's Palsy-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Blood pressure above 130 over 90 and severe IBS post vaccine, despite other flu like symptoms resolving. Normally she has 110 over 70, and her IBS can be controlled by otc like Immodium 2mg. There is no special clinic here and she can't afford primary care please help.
Information has been received from a physician concerning a 14 year old female with no pertinent medical history and drugs allergies who in April 2000, was vaccinated with a dose of VARIVAX (Merck).  There was no concomitant medication.  On 04-MAY-2009 the patient developed zoster.  The patient has 12-15 blisters on left dermatome and was experiencing pain.  No laboratories studies performed.  The patient sought medical attention through an office visit.  At the time of this report the patient had not recovered.  Additional information has been requested.
Initial and follow-up information has been received through the Merck pregnancy registry from a physician and a nurse concerning a 25 year old female with drug hypersensitivity to aspirin with a history of 3 pregnancies and 1 live birth (2 terminations of pregnancy) who on 18-DEC-2006 was vaccinated with a first 0.5 ml dose of Gardasil (lot reported as "1101F"). There was no concomitant medication. On an unspecified date, the patient took a home pregnancy test and it was positive. On 09-JAN-2007 the patient was seen in the physician's office and blood test was drawn for pregnancy (results not reported). The patient's last menstrual period was 09-DEC-2006 and estimated date of delivery is 15-SEP-2007. The physician reported that he was going to tell the patient to terminate the pregnancy. Follow-up reported that on an unspecified date the patient terminated the pregnancy. Upon internal review, terminated pregnancy was considered to be an other important medical event. Additional information has been requested.
16 month old patient received Pediarix  instead of dtap; This will be dose4; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date 17th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments: Agency reported that patient received Pediarix instead of dtap. This would be dose 4 (1 more than the normal schedule). The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix instead of dtap as a 4th Dose, which led to wrong vaccine and extra dose administered.
This spontaneous report was received from a physician via company representative referring to a 20-year old female patient. The patient's concurrent conditions, medical history, concomitant medications and drug allergies were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) reconstituted with sterile diluent (MERCK) for prophylaxis (dosing details, anatomical location, lot# and expiry date were not reported). On 10-AUG-2018 (reported as "a week ago"), the patient experienced white rash. On an unknown date, the patient came in to the physician office with a white rash and subsequently was hospitalized (in an unknown hospital) for 4 days. The physician had determined the rash as chickenpox. An AE was filed because the physician mentioned that he believed the patient had probably received varicella virus vaccine live (Oka/Merck) at some point. Outcome of the event varicella was reported as recovered. Causality assessment was considered as related to varicella virus vaccine live (Oka/Merck). No Product Quality Complaint (PQC) was reported.
Pt recvd vax & 10 days p/vax exp swelling of joints, back pain & fatigue;
Spondylitis ankylosing aggravated; Difficulty sleeping; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "Difficulty sleeping"; ANKYLOSING SPONDYLITIS (medically significant) with onset 2021, outcome "not recovered", described as "Spondylitis ankylosing aggravated". The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "spondylitis ankylosing aggravated" and "difficulty sleeping" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : 22K-163-4453517-00 AbbVie;
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in left arm and on 17Mar2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Neagtive; (20May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10-4-14 Immunization given (L) arm approximately 1215. By 1600, arm sore. By 1800 could not move arm away from body - much pain. No sleep that night. Mon. went to pharmacy and told no other reactions reported and to call you. Arm was 99% better by Thurs. (10-8).
inadvertently administered an expired Pediarix dose to a 2 month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number YP2Y3, expiry date 08-APR-2023) for prophylaxis.   On 10-APR-2023, the patient received Pediarix (right thigh). On 10-APR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Pediarix dose to a 2 month old patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2023 The registered nurse enquired, how to proceed and what is the efficacy? The reporter reported that they inadvertently administered an expired Pediarix dose to a patient.  The registered nurse confirmed dose was administered in their facility.  The reporter did not consent to follow-up. The patient inadvertently received an expired Pediarix vaccine which led to expired vaccine used.