chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; Difficulty breathing; Dizziness; Loss of appetite; Lost 5 pounds; Weakness; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of appetite) and WEIGHT DECREASED (Lost 5 pounds) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive in March 2020, COVID-19 virus test negative (before surgery) and Surgery (1 week before the first vaccine) in February 2021.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (Lost 5 pounds), ASTHENIA (Weakness), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, COUGH (Coughing), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (Lost 5 pounds), ASTHENIA (Weakness), HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved.            Concomitant medications were not provided by the reporter.  Treatment information was not provided by the reporter for dose two events.   This case was linked to MOD-2021-039316 (Patient Link).
Started with foggy thoughts, inability to focus or remember, extreme fatigue, memory lapses mood swings. Developed into increased depression, further fatigue requiring daily naps, inability to focus or get charting done in timely manner, abdominal bloating, constipation. By end of July , abdominal swelling noticeably bigger, constipation is chronic, a third depression medication is added. Now requiring 1-2 naps daily and rest frequently during activity. By august continue and swelling, now with new onset right lower extremity lymphedema, memory lapses, depression, inability to focus nausea, vomiting, ascites, frequently exhausted. Referred self to liver doctor who performed scan and found new onset NASH at stage 3 cirrhosis. This was not there on previous scans only chronic fatty liver which 1/3 of the American population has. Doctor and I feel like the shot may have interacted with my autoimmune and caused my body to attack my liver nearly killing it.   Of all of the 7 or 8 risk factors for NASH, I have exactly 1 risk factor.  This is unfortunate and I have not been able to work since august and am about to lose my insurance because of it. :(
pt recvd vax;pt in car & mom reported hives over face, difficulty w/ breathing, n, v;returned to med unit; client awoke & oriented x 3; allergic rxn to vax; lehtargy, vomited; pt went into anaphylatic shock;
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Achy muscles, headache, lasted 12 hours, red blotch at injection site and sore arm still present
Patient is a 76 y.o. female patient of local MD with history of Colon Cancer with mets, CKD, DM II, Gout, HTN, HLD, Hypothyroidism, RA, Stroke, Anemia, CAD presented to local Hospital with Fever.  Was found to be neutropenic, with neutropenic fever started on broad-spectrum antibiotics and consult placed to infectious disease and oncology.  Tested positive for COVID-19 and was hypoxic.  Over the following days able to be weaned off oxygen.  With resolution of fevers and negative cultures, fevers likely all due to COVID infection.  Received Neupogen per oncology with resolution of neutropenia.  With improvement of symptoms patient to be discharged home.     COVID-19 Neutropenic fever Acute respiratory failure with hypoxia Reported fever of 103.8 at clinic COVID test positive RLE venous doppler neg for DVT UA neg, CXR no acute process. Lactate normal Neutropenic on presentation Oncology recommended empiric antibiotics Blood cultures NGTD Continue vancomycin, cefepime for now, likely be able to de-escalate in the near future as no longer neutropenic On Decadron and remdesivir while inpatient Neupogen given 12/14 and 12/15, neutrophils trending up ID and Oncology consulted Initially hypoxic requiring 2 L nasal cannula, has since been weaned to room air Continues to have intermittent fevers PT/OT consulted      Colon Ca with metastasis Pancytopenia Follows with personal Dr. Pancytopenia due to chemotherapy Hb 8.7, Plt 75, WBC 1.76 on admission On Chemotherapy Oncology following Neupogen started 12/14, since been discontinued with resolution of neutropenia PAF S/p aortic & mitral valve replacement On warfarin   HLD Continue statin   Chronic Pain RA Continue prn norco   Severe malnutrition POA Likely secondary to metastatic colon cancer Dietitian consulted
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-JUN-2012, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 08-NOV-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication is provided by reporter. No treatment information is provided by reporter. Patient medical history include some medical training and a pre -existing medical condition.  This case was linked to MOD-2021-316913 (Patient Link).
Extreme soreness in left arm, worsening into Sunday.  Was unable to lift arm.  Still experiencing soreness and some discomfort in the arm.  Also experienced chills and fever as  high as 101 on Sunday (day after injection).
Patient was given 0.5mL instead of 0.25mL of Moderna Covid vaccine
Pain in my left shoulder started the following day. That night the pain was bad enough that I slept in a recliner with my left arm above my head as that was the only way I could get comfortable. The pain would ebb and flow over the next few days, but it spread to my right shoulder as well. Now I have that pain in both shoulders. The pain usually is worse in the morning but gets better with shoulder stretching throughout the day. I still have the pain when I wake up. Sometimes it gets much better throughout the day but sometimes it remains painful, even a month later.
No adverse event; Received Bivalent booster for First Primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose).    No concomitant medications were reported.  It was reported that on 29-Nov-2022, the patient walked in telling the staff that she never received the Primary series. She was asking for a 2nd primary dose.  No treatment medications were reported.
arm sore; got a little warm; got a little headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in arm left, on 22Apr2021 (Lot Number: EW0171) and on 14May2021 (Lot Number: EW0182), (at the age of 28-years-old) respectively, both as single doses for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that his second shot was scheduled at the location where he got his first dose, but he could not go to that location, so he rescheduled the second dose at different location. Further he added that, the guy at the second location did not know he was going to get the second shot hence, the patient was afraid if he might get the first shot twice and wanted to know if he should be concerned about this. On an unspecified date in May2021, the patient had arm sore, got a little warm and headache. The patient experienced the same side effects as he did with the first dose and stated that the symptoms started the next day after each dose and lasted about two days (exact dates were unknown). The outcome of the events was unknown.   Additional information is requested.
no AE; some "temperature problems" that the vaccine underwent; This spontaneous report was received from a consumer and physician's office manager, referring to a  patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 10-SEP-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prefilled syringe, lot # S036495 expiring on 13-SEP-2021, for prophylaxis (exact dose, route and site of administration were not reported).   The reporter stated they received a message from their physician that the patient and her husband needed to be revaccinated for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), due to some temperature problems" that the vaccine underwent. The caller and her spouse, would have an appointment on 11-NOV-2020, to receive another pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine.  The office manager confirmed no adverse event occured. This is one of two reports received from the same reporter (cross-referenced with US-009507513-2011USA008179). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA008179:
Vaccine vial was to be administered on or before 5/5/21 at 1500 however a dose was administered on 5/6/21 at 1000.  Reported to Pfizer as well.
Shingrix 1st dose given 9/29/23; Pt 2nd dose supposed to be on or after 11/29/23 (2 months after 1st dose). However, 2nd dose was given on 11/2/23 instead. When administering RPH check system for vaccination history, RPH wrote down 1st vaccination date incorrectly as 8/29/23 instead of 9/29/23.
Moderna Covid-19 Vaccine  Patient started vomiting 6 and half hours later, staff reported it and we are reporting it as an ADR
It?s been 2 weeks today I received my first vaccine. My arm became itchy . I pulled up my sleeve to see if I had a bite . Then I realized it was where my vaccine was given. I looked I the mirror and saw a big red swollen area   I put some Benadryl cream on it because it became very,itch, which seemed to help with the itching. Now, I. Just keeping an eye on it.
Second dose of Shingrix vaccine was administered by RN to patient subcutaneously in the left arm instead of intramuscularly in error. Per the CDC "Shingrix should be injected intramuscularly in the deltoid region of the upper arm. Subcutaneous injection is a vaccine administration error and should be avoided. However, if you inadvertently administer Shingrix subcutaneously, that dose is considered valid and does not need to be repeated." Patient was observed for any adverse reaction prior to leaving the clinic. No reaction noted. Patient left clinic in good condition. Patient is aware Shingrix vaccine is up to date. Patient was encouraged to call back the clinic with any signs or symptoms of a reaction.
Patient has had palpitations since the day after getting her second booster dose. She has seen her primary care provider, and now cardiology, who sent her to the emergency department 5/10/22 for elevated d dimer. She was diagnosed with pulmonary emboli in the emergency department yesterday.
Client had the second dose of VZV on 4/15/13 and her right arm got red and swollen. She felt some induration in the back of the arm. We measure it and the redness was 70 mm long by 50 mm wide. Client called her doctor, who recommended ice compresses. We told client to follow what her doctor prescribed. The redness is subsiding as we could see by the picture client took with her camera-telephone and showed to nurses.
We both have the Omicron virus right now; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (We both have the Omicron virus right now) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (We both have the Omicron virus right now). At the time of the report, COVID-19 (We both have the Omicron virus right now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Omicron virus confirmed by a home test..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Booster shot was planned on January 18th but was confirmed with Omicron virus by a home test. No concomitant medication were given. No treatment information were given.  This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19. The event occurred on an unknown interval after receiving an unspecified dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19. The event occurred on an unknown interval after receiving an unspecified dose of mRNA-1273. SARS-COV-2 Test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 2, single (Lot number: FC3182) at the age of 55 years, in right arm for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE), on 27Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for influenza. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Pfizer COVID-19 vaccine 1st dose, Lot Number / Expiry Date: Unknown, Route, Anatomical Location: In arm, unknown which arm.), administration date: 28May2021, when the patient was 55-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st dose: 28May2021/2nd dose: 27Aug2021"; HEADACHE (non-serious), outcome "not recovered", described as "ongoing headache everyday". Therapeutic measures were taken as a result of headache. Additional information: Caller is calling about the Pfizer COVID-19 vaccine. Caller got both shots at #, confirmed 2 total doses of the Pfizer COVID-19 vaccine, and caller has been having an ongoing headache everyday, been to the neurologist and is still having headache. Calling to report headache. Caller has his vaccine card. Caller is going to look on some medications that HCP prescribed for caller's headache to see a date. 03Sep2021 is when caller received the medication, Etodolac,(400mg, quantity of 60,take 1 tablet by mouth twice) for headache. Unknown exact date for when the headache started, but that is why caller got the medication, for headache. Caller is just reporting headache today, not sure, has been to HCP about headache and HCP also prescribed Sumatriptan medication, 50mg, for caller's headache.  Vaccination Facility Type: Pharmacy/ Drug Store. Vaccine not Administered at Military Facility. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: Got the flu shot the same day as the 2nd dose of the Pfizer COVID-19 vaccine. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. Family Medical History Relevant to AE(s): No. Relevant Tests: Unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200866909 same patient/reporter, different dose/vaccine licensing;
It presented as a head cold but as a precaution I used a home COVID-19 test that came back positive. I called my doctor to discuss my symptoms, he prescribed Lagevrio antiviral since I had a history of pneumonia. Within a week I was feeling much better. I do not have any lingering side effects.
The patient arrived at the clinic w/ HHA w/most translation and interaction completed by HHA due to the patient's limited language ability.  The HHA and the patient were informed that Moderna covid-19 is given every Tuesday and Thursday.  The patient and HHA want to proceed w/ vaccination. Questionnaires were screened and the patient received the first dose of Moderna w/ a 15 minutes observation. The patient completed the observation without any complication or discomfort and HHA were given the CDC vaccination card at the 15 minutes mark.    The HHA returns one hour later without the patient and violently screams that the patient was not here for covid-19 vaccine instead the Flu shot. The HHA connected the patient's daughter via phone and the daughter further explained that the patient had completed the covid-19 vaccination of Pfizer approximately 02/2021. The daughter reported no adverse reaction and was informed of the EUA signs and symptoms to monitor, when to call 911 and emergency contact for the provider given. The daughter was informed that such missed communication resulted in this event and department of health will be contacted and report such event.    The Health and Department of Health Covid-19 hotline were both reported of the event. The daughter was told of what DOH had informed.
Pain and weakness in shoulder and arm.  Inability to lift arm overhead or lift weight with it.