chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 07-FEB-2017 at 08:12, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
had a terrible blood disease; can hardly walk; legs are all weak, legs just give way; Some days cannot walk; collapse for no reason, falling down for no reason; feet are all swollen, legs and feet were swelling; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk) and FALL (collapse for no reason, falling down for no reason) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk), FALL (collapse for no reason, falling down for no reason) and PERIPHERAL SWELLING (feet are all swollen, legs and feet were swelling). At the time of the report, BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk), FALL (collapse for no reason, falling down for no reason) and PERIPHERAL SWELLING (feet are all swollen, legs and feet were swelling) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication were reported.  The reporter stated that patient was in his 60s alive. Patient had the same thing as the other patient of falling down for no reason. Patient could hardly walk. Some days patient was ok and some days patient could not walk. Patient doctor knew nothing about this, so the reporter told to check with the doctor if it was from the Moderna's shot and so the doctor was doing blood work. But the doctor did not seem to know that. The doctor did not even think to see if it was related to the shot.  It was reported that the doctor was doing blood work, however, the results of the tests were not provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Vaccine due needle leakage, patient did not attain the full dose; Vaccine due needle leakage, patient did not attain the full dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine due needle leakage, patient did not attain the full dose) and SYRINGE ISSUE (Vaccine due needle leakage, patient did not attain the full dose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Vaccine due needle leakage, patient did not attain the full dose) and SYRINGE ISSUE (Vaccine due needle leakage, patient did not attain the full dose). At the time of the report, UNDERDOSE (Vaccine due needle leakage, patient did not attain the full dose) and SYRINGE ISSUE (Vaccine due needle leakage, patient did not attain the full dose) had resolved. Not Provided      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.   No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I had my vaccination on 03/18/2021. On 03/25/2021 I went to the emergency room because I felt like I was having a heart attack with shortness of breath and pain in chest. They deemed it was another episode of Pericarditis and was put on a Holter monitor. I was told I was COVID-19 positive in 12/2019. I was initially diagnosed with Pericarditis in 2020.
Red at injection site; Chills; Very swollen and painful lymph node in armpit of left arm injected; Very swollen and painful lymph node in armpit of left arm injected; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 16:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 19Apr2021, when the patient was 48 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 29Mar2021, when the patient was 48 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Nov2021 16:00, outcome "unknown", described as "booster"; VACCINATION SITE ERYTHEMA (non-serious) with onset 15Nov2021, outcome "recovering", described as "Red at injection site"; CHILLS (non-serious) with onset 15Nov2021, outcome "recovering", described as "Chills"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 15Nov2021, outcome "recovering" and all described as "Very swollen and painful lymph node in armpit of left arm injected". Therapeutic measures were not taken as a result of vaccination site erythema, chills, lymphadenopathy, lymph node pain.  Additional Information:Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Device Date: 17Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms began with headache (very rare for this patient) then he noticed low grade fever, sore throat (hoarseness) and dry mouth. Sunday morning woke feeling weak, dizzy, sweating, syncopal, but did not lose consciousness. Ran temperature of 99.8F on Sunday, about 2 degrees above his baseline. Remained in bed all day. As of Monday he began feeling much better, temperature normal, but with residual soreness and aches.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy NOS (Unknown drug).    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.            The race was reported as No concomitant medication was reported. Symptoms happened after 7 days on 30-May-2022 with outcome as recovering. Patient previously received a COVID-19 Vaccine. Device date was reported as  04-Jun-2022  Company Comment: This is a spontaneous case concerning a 52-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19, but symptoms returned after 7 days. No other clinical or treatment details were given. The reported outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 52-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19, but symptoms returned after 7 days. No other clinical or treatment details were given. The reported outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Myalgia, Arthralgia, Fever, fatigue, loss of appetite - worse between 12- 26 hours post vaccination,  continues mildly today 96 hours post vaccination Narrative: I used acetaminophen and ibuprofen sporadically to treat symptoms. Symptom onset was approximately 4-6 hour post-vaccination and was it's worst 12-26 hours post-vaccination. Symptoms include low grade fever (chills and poor temperature regulation), sever muscle and joint aches and pains, low to no energy, and loss of appetite. Still experiencing mild symptoms now, still treating as above but lower dosing. Honestly, neither acetaminophen nor ibuprofen did anything to relieve symptoms.
Patient with severe left shoulder pain and weakness in the days following the shot that continues to worsen. we are now one week out and she essentially is unable to lift the arm. she also has associated numbness/tingling down the arm as well.
A physician reported that a 7 month old male received his firt doses of Prevnar, HibTiter, and Infanrix vaccines on 8/12/02. Approximately 24 hrs post-vaccination, the infant developed *"severe"* vomiting and retching. *The infant recovered.* This child also developed vomiting and retching following receipt of a subsequent dose of prevnar.
Mild Swelling; Soreness; Fatigue; Rash around injection site; Hives extending / spread out  about 8cm x 9cm; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Covid-19 vaccine (the patient had a Covid-19 vaccine in the last year).   In July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In July 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced swelling, pain, fatigue, injection site rash and injection site hives. The patient was treated with allergy medication {nos} (Allergy Medication). On an unknown date, the outcome of the swelling, pain and fatigue were unknown and the outcome of the injection site rash and injection site hives were not recovered/not resolved.   It was unknown if the reporter considered the swelling, pain, fatigue, injection site rash and injection site hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 26-JUL-2022 Reporter's Comment: The reporter had a medical question about a patient with an unusual side effect. So he just received his first Meningococcal B vaccine last week.  He had some initial mild swelling, soreness and fatigue.  The day before reporting, 6 days after getting the vaccine, he developed a rash around the vaccine site.  It looked like hives extending from where the injection was.  That skin was clear and the hives spread out from it about 8cm by 9cm.  He was already on daily allergy medications but the rash was not itchy or painful.  The patient did not see report of rash so was wondering on it since it was a delayed appearance.  The reporter wanted to know also would there be any reasons he could not get the 2nd dose.  The patient's mother was extremely anxious and worried about it.  She was afraid it was related to also having a covid vaccine in the last year. The reporter attempted to contact healthcare professional to get the administration site and side and if the symptoms (besides rash and hives) were resolved, but he/she was unable to reach her. The reporter consented to follow up via postal.
Information has been received from a licensed practical nurse, for GARDASIL, a pregnancy registry product, concerning a 24 years old female patient with no medical history and no allergies who on 09-APR-2007 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 657005/0314U). The patient received IM the second 0.5ml dose of GARDASIL on 04-JUN-2007 (lot # 657002/0337U, which belongs to VARIVAX ). There was no concomitant medication. On 29-JUN-2009, the patient received the third dose of GARDASIL (lot # 661841/0653x). The patient did not receive any concomitant vaccinations when the three doses of GARDASIL were administered. After the patient was administered her second dose of GARDASIL she was determined to be pregnant. The patient required an unscheduled c-section on 18-MAR-2008 due to hypertension. The infant was a normal, full term baby with no complications. At the time of this report, the patient had recovered. It was reported that the patient sought unspecified medical attention. Upon internal review, the unscheduled c-section due to hypertension was determined to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a registered nurse via a company representative, referring to an 85 year old female patient. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medications included sterile diluent (STERILE DILUENT). On 07-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, anatomical location, route of administration, lot # and expiration date were not provided) for prophylaxis. On 24-APR-2017, the patient was admitted to an unspecified hospital due to a "lack of efficacy with ZOSTAVAX". On an unspecified date during hospitalization, the patient was given gabapentin as a treatment for the event. At the reporting time, the outcome of the event was not provided and it was unknown if the patient was discharged from the hospital. Additionally, reporter's causality assessment between vaccination failure and  ZOSTAVAX was not provided. The lack of efficacy was considered serious as it led to hospitalization. Additional information has been requested.
Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 04 Mar 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 04 Mar 2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 11:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Mar-2022 at 11:13 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 04 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 04 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had a ethnicity. The patient had received the vaccine dose as booster. No concomitant medications were reported. It . Vaccine went into 2 to 8 degree Celsius thaw state on about 24 Dec 2021. The vaccine was administered up until its manufacturing expiry date of 04 Apr 2022.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Pain to left upper arms after pneumonia vaccine, swellind, redness and pain at the injection site.
VERY DIZZIE/NAUSEA COULD NOT GET OUT OF BED AND WAS DIZZIE MOST OF THE DAY .
Diarrhea after the 2nd dose; Stomach pain after the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea after the 2nd dose) and ABDOMINAL PAIN UPPER (Stomach pain after the 2nd dose) 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 19-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea after the 2nd dose) and ABDOMINAL PAIN UPPER (Stomach pain after the 2nd dose). At the time of the report, DIARRHEA (Diarrhea after the 2nd dose) and ABDOMINAL PAIN UPPER (Stomach pain after the 2nd dose) outcome was unknown.            Patient experienced diarrhea and stomach pain,  patient received second dose of Moderna vaccine on 19 Apr 2021.  No relevant concomitant medications were reported.  No treatment details were reported.
Rash all over her body; now under her arms mostly.; This is a spontaneous report from a contactable consumer (patient's sister) via a Pfizer-sponsored program. A 85-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection) via an unspecified route of administration in Arm Left on 20Jul2021 (at the age of 85-Years-old) (Batch/Lot Number: EWO217; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. The patient's medical history included ongoing High blood pressure, ongoing Thyroid. Concomitant medication included levothyroxine taken for thyroid and is ongoing, prednisone Everyday a pill in the morning. She stated her doctor told her she can't leave this medication and ongoing amlodipine besilate, perindopril arginine (COVERAM) taken for high blood pressure. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration in Arm Left on 29Jun2021 (at the age of 85-Years-old) (Batch/Lot Number: EWO191; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. On 21Jul2021 at 02:00 pm, 1 day after vaccination, the patient experienced rash all over her body; now under her arms mostly. Reporter stated at first they thought it was from mosquitos but it was nothing like that. Later it improved and it was under her arms mostly now. It was reported that she applied some alcohol. Reporter stated they are wondering if this can be a reaction from the vaccine. It was reported that it has been subsiding, the rashes are only under her arms now. Reporter wanted to know if it was a reaction from the Pfizer COVID-19 vaccine. Therapeutic measures were taken as a result of rash all over her body, now under her arms mostly.The patient received treatment for the adverse events. At the time of this report, the outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.