chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Pharmacist's stated They administered the vaccine from 10Dec2021-13Dec2021.
Injection site became red and upper arm became very tender & sore for 4 days.   After the first 24 hours I experienced all over body aches and fatigue for approximately the next 36 hours.
Joint Pain and Stiffness in feet, hands, right  knee, neck. Never had previous pain; went to bed with no pain and woke up the next morning with stiff feet and hands and pain in feet, hands, right knee, and neck.  Went to doctor on April 2, she ordered bloodwork, labs came back positive for Rheumatoid arthritis.   Appointment with Rheumatologist scheduled for June 24, 2021
"side effects? on the Milder side"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION ("side effects? on the Milder side") 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) at an unspecified dose. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION ("side effects? on the Milder side"). At the time of the report, VACCINATION COMPLICATION ("side effects? on the Milder side") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant product use was not provided. Treatment information was not provided   Reporter did not allow further contact
Pt states she experienced hives on both arms, her back, and her stomach. They resolved on their own after a few days.
red-swollen lt leg; screaming episode high-pitched abn cry or screaming lasting > 4 hr;
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 21-JAN-2014 the patient was vaccinated with RECOMBIVAX HB, 1 ml, intramuscular. The medical assistant is reporting that the patient was inadvertently administered RECOMBIVAX lot H018635 that had expired on 16-DEC-2013. No adverse effects reported. Additional information has been requested.
I had sharp pain spasms of nerve and muscles twitching all over my body for 2 days.
muscle weakness; Painful Legs; can't walk; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful Legs), GAIT DISTURBANCE (can't walk) and MUSCULAR WEAKNESS (muscle weakness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Painful Legs) and GAIT DISTURBANCE (can't walk). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness). The patient was treated with TRAMADOL for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Painful Legs), GAIT DISTURBANCE (can't walk) and MUSCULAR WEAKNESS (muscle weakness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant follow up received; Contact information updated, new event added and event outcome also updated
Body temperature was all over the place.  Chills, shaking, sweats. Severe headache, back ache, dizziness.
Severe anemia post-vaccine (levels of hemoglobin dropped down to 6.2), had to have a covid test, marked as still positive from January, told by doctor people can test positive for up to 90 days after initial infection. Internal bleeding due to an ulcer in the stomach. Hospitalized 5 times during the event, given iron infusions, the second hematologist stopped the iron tablets (because they upset the stomach), the irritation of the stomach seemed to stop and have not had the bleeding since then. Double transfusion, iron infusions, have been feeling much better.
Date: 3/22/2021  Problem:  Notes:   Time: 0930 a.m.. Patient observed in chair with head titled, eyes closed, sweaty, clammy and making snoring noises. Patient able to arouse. VS 97.4,20,44,99/54. 98% on Room air. Patient verbally responsive and stated that he did not eat breakfast but drank two cups of coffee. Snacks and water offered and consumed. Legs elevated. patient is currently resting. Will continue to monitor.  Time: Vitals rechecked @ 97.7,51,18,104/75. Patient resting in chair AAOx3. Patient called and notified wife. Patient stated that he feels better. close monitoring continues.  Time: VS O2 99% on Room Air, 97.7,18,69,104/64. patient left facility in stable condition.
pt says her right arm has started tingling, itching, and becoming red around the injection site.  Her right shoulder blade is very achy.  Pt will contact her PCP.
3rd dose Moderna was 10/26/21. November 9th developed respiratory sx. Cough lasted several weeks. Had CT scan for another issue and found that I had a small pericardial effusion.  This elicited an echocardiogram which showed severe left atrial enlargement and pulmonary HTN. I am unsure if the vaccine caused this or if my respiratory illness on 11/9/2021 may have been undiagnosed COVID. I believe that either the vaccine or undiagnosed COVID caused these conditions.  My previous echo from 7/21/2020 was completely normal.
p/vax pt awoke w/mild T100; had pain in rt arm; site of inj red & limited mobility in arm; saw MD; prescribed cold/heat intermittently to inj site & ibuprofen x4hr; pt still has malaise & pain in arm as of 8/25/99
Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatigue; This is a spontaneous report from a contactable physician (patient). A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration in left arm on 05Jan2021 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) in the right arm on 16Dec2020 12:00 PM. The patient had no other vaccine in four weeks. The patient had not been diagnosed with COVID prior vaccination. The patient experienced severe sweating, fever, weakness, "worst headache of my life," searing eye pain for the last 2 months, daily headaches and fatigue on 06Jan2021 12:00 AM (also reported as first 48 hours). The events resulted in disability or permanent damage. Treatment was administered for the reported events. Outcome of events was unknown. The patient underwent Covid nasal swab test post vaccination on 27Jan2021 with negative result.; Sender's Comments: Based on temporal association and known drug profile a contributory role of BNT162B2 to the reported events  cannot  be excluded.  Case will be reassessed if additional information is received.  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.
He got his vaccine, his arm was swollen and that was it.  This morning when he woke up at 7:00 AM went to the restroom and listed up the sleeve of his shirt and noticed that the injection site skin was kind of worn away like scraping it as a fall and it was wet.  There is a mark on the T-shirt where it was oozing.  It was  not itching, and he did not have to put cream on it like the first vaccine, had no reaction.  He is arm is normal swollen, but wet.  There is no clear color of the discharge other than the staining on the shirt.  He did put Neosporin on it and a band-aide.  You did call the department of health where he had it done, and they gave him our phone #.   He has no numbness, problem with moving the arm or anything.  This is the same arm that he had the 1st vaccine on.   He does feel fine, no fever, just this oozing/wet area on the injection site itself.   This injection is in the upper arm underneath the shoulder muscle in the front.    He did have a colonoscopy on Tuesday of this week with sedation, and everything was fine.    With Moderna COVID vaccines had some reactions, fever, extreme fatigue.  He got a flu vaccine and had extreme depression for months which his doctor said was normal.
pt recv vax; devel fever of 103;pain & induration at inject site,cervical and axillary lymphadenopathy;
This spontaneous report as received from a registered nurse refers to incorrect product storage due to on 02-FEB-2015 unkonwn number of patients of unknown ages and genders were vaccinated with improperly stored doses of GARDASIL (does, lot #, expiration dates and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This one of several reports from the same source. Additional information is not expected because we cannot contact the physician.
IMMEDIATELY UPON INJECTION, A FIRM BUMP THE SIZE OF A DIME FORMED AT THE SITE OF INJECTION.  PATIENT DENIED ANY SHORTNESS OF BREATH, DIZZINESS. SHE STATED SHE FELT "FINE." AN ICE PACK WAS PLACED AT INJECTION SITE AND PATIENT WAS ASKED TO BE OBSERVED FOR 15 MINUTES.  AFTER 10 MINUTES OF OBSERVATION, THE BUMP AND REDUCED IN SIZE AND PATIENT INSISTED SHE FELT FINE AND LEFT THE FACILITY AGAINST THE PHARMACIST'S ADVICE.
Presents to the emergency department to be evaluated for possible aspiration.  The patient had some vomiting after a tube feed, and shortly thereafter, developed some shortness of breath.
Initial unsolicited report received from a healthcare professional on 25 September 2014. This is a cluster case of 25 patients (demographics unknown). 25 patients had received a dose of FLUZONE QIV, (batch number UI196AA, expiry date: 30 June 2015, dose in series and site of vaccination were not reported) intramuscularly on an unspecified date. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On an unspecified date, after vaccination, patients experienced "more pain upon administration of this vaccine than any other vaccinations ever received". It was stated that all patients reported pain, after needle placed, when vaccine was being administered into site. In addition, of those 25 patients about 10-15 had swelling, red, rash at injection site. It was also stated that most of the 25 patients reporting the pain upon injection were under the age of 64 years. Laboratory tests and corrective treatments were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up report received from a physician on 28 April 2015. It was reported that reporter did not have any additional information to provide or each patient's identifier. Corrected report: The coding of event was updated to vaccination site pain. Coded events of about 10-15 patients had swelling and red rash at injection site. Documents held by sender: none.
Minor sourness in arm and extreme fatigue lasting the day of injection and the following day. By Saturday I was fine.
I received the vaccine on 3/25/2021 at 5:30PM and had general soreness in the arm the injection took place. Soreness was remarkable until four days after the injection. Night of 3/30/2021 at approximately around 9:30 pm I felt soreness in the left axillary region (in my left armpit). This at first was thought to be unremarkable as I was wearing a tight shirt at the time. However, after switching to looser clothing the soreness and pain continued and now considered remarkable. The day after (3/31/21 Today of this report), I still have pain and what feels to be a swollen lymph node in the left axillary region (in my left armpit). This is sore and painful and feels palpable.
Syncope - Running a 5K, child is a half marathoner and 5K state champion. Pulse went to 172. Ash gray in face and memory loss of event. This had never happen before, occurred again on 10/3/2009. Emergency room, doctor ran EKG and ECO showed nothing. 10/28/2009 records from Cardiologist and PCP for dates 9/22/2009 and 10/13/2009. Patient presented with sx of syncope, incoherent speech, paleness, and "passing out" while running a marathon on 9/19/2009. Cardiac workup was negative. Patient saw new PCP 10/13/2009, asymptomatic at this time. Further dx tests were ordered.
Upset stomach, exhaustion, leading to high temperature reading of 103.8 at highest. Still running a fever, 102 on 04/05/2017.
tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue; tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue; This is a spontaneous report from a contactable consumer or other non-HCP.  A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in Right Arm on 03Mar2021 as single dose, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in Right Arm Right on 10Feb2021 as single dose for covid-19 immunization. Medical history included rheumatoid arthritis, increased blood cholesterol, hypothyroidism, raynaud's phenomenon. Concomitant medications included hydroxychloroquine (HYDROXYCHLOROQUINE); atorvastatin calcium (ATORVASTATIN CALCIUM); pantoprazole (PANTOPRAZOLE); levothyroxine sodium (LEVOXYL); ergocalciferol (VIT D). The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. On 10Mar2021 the patient experienced tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue. No treatment was received for the events. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 10Mar2021. The outcome of event was recovering.   Follow-up (15Mar2021): New Information received from the contactable consumer included event onset date and was updated.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 03Mar2021, first dose on 10Feb2021 for covid-19 immunization.  On 10Mar2021 the patient experienced tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue.  Based on information available, vaccination failure in the patient cannot be excluded.
02/25/2002-Pt given MMR after denying pregnancy and told not to get pregnant for 3 months 04/02/2002-call from pt's PCP-Pt is now pregnant, about 6-8 wks along. 04/26/2002-Call to PCP's office, they state that the EDC is 11/13/2002
pt recvd vax; to er w/ URI sxs & died on 27nov; obituary did follow; final dx streptococcal epiglottitis; lung biopsy demonstrated possible H influenza;
feeling hot face; fever; feeling "drained"; sore body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot face), PYREXIA (fever), FATIGUE (feeling "drained") and MYALGIA (sore body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (feeling hot face), PYREXIA (fever), FATIGUE (feeling "drained") and MYALGIA (sore body). At the time of the report, FEELING HOT (feeling hot face), PYREXIA (fever), FATIGUE (feeling "drained") and MYALGIA (sore body) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
First night began with a slow rising fever. Next day had severe fever of at least 101 or 102 with chills and sweats. Dizziness and extreme temperature swings
I was very achy and feverish for about two days afterwards. Now, the symptoms I have now are basically smells aren't registering probably like they did before. A lot of foods smell bad like burning rotten flesh. It started in August 2021. It continues until this day. I was referred to an ENT by my primary care doctor who sent me for an MRI that came back negative. I was diagnosed with parosmia.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult male patient who received FLUARIX. The patient's past medical history included shoulder operation. On 19th November 2015, the patient received FLUARIX .5 ml. In November 2015, less than a week after receiving FLUARIX, the patient experienced injection site pain. On 19th November 2015, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX. Additional details were received as follows: The reporting physician himself was the patient. The patient had shoulder surgery in past and so he did not like to receive immunizations in the deltoid. The reporter was inquiring if there any data associated with the administration of FLUARIX in the gluteal area. The patient received a dose of FLUARIX in the gluteal area, which led to vaccine administered at inappropriate site. The patient stated that he experienced moderate pain. The reporter stated that, he did not like to give any further information regarding the event.
31 y/o AD WM SM with pain and stiffness multiple joints after receipt of AVA #2 and HDCV #1 over seas on 2/11/08 prior to returning to military base on 2/19/08.  Joint Pain, multiple joints start 03/18/2008.  Gait abnormality start 03/18/2008 Walks slowly and stiffly, trying not to bend right knee
Ringing in the ears that was noticed at 5:00 am the next morning and has persisted continuously.
This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL9265), at the age of 77, via an unspecified route of administration, on Feb 11, 2021, single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing (COPD). No investigation assessment. Concomitant medication included inhaler taken for COPD. The patient experienced reddish purple rash on legs and arms on 2021. Reportedly, patient went to doctor. The outcome of the event: unknown. No follow-up attempts possible. No further information expected.
POST VACCINE PT REPORTS EXPERIENCING HEART RACING. PT TRANSPORTED TO OBS AT 1605 VIA WC. VITALS OBTAINED AND MONITORED. PT STATES SHE IS ANXIOUS AND HAS EXPERIENCED THIS BEFORE. SYMPTOM RESOLVED.  PT RELEASED TO HOME BY SELF AT 1627. VITALS AS FOLLOWS: 1610 LYING BP 144/88 HR 102 RR 20 SPO2 97% 1615 LYING BP 149/96 HR 94 RR 20 SPO2 97% 1620 SITTING BP 160/94 HR 84 RR 18 SPO2 98 1625 SITTING BP 137/88 HR 89 RR 18 SPO2 98% 1626 STANDING BP 141/94 HR 73 RR 18 SPO2 97%
Pt contacted the pharmacy on Monday 9/7 because the area close to the injection site was red, swollen, and warm
Chest/upper abdominal pain/discomfort (crushing feeling), does not radiate and occurs intermittently. Decrease in appetite.
After receiving 2nd injection (MMR) the client slumped over in the chair, his eyes rolled in the back of his head, he started to shake similar to a seizure.  Mom requested that I call 911, so I did.  His BP was 68/50, very pale and diaphoretic.  No hx of fainting after imm., no history of seizure.  Client stated that his vision was impaired and does not remember what happened after the injection.  Ambulance came and he was transported to hospital per mom's request.  Client's color was returning and he was in good spirits as he left.
UK NHS Rapid Test:postive; Rapid Test:postive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 11:30 (Lot number: FL3197) at the age of 43 years as dose 3 (booster), single, administered in arm left, administration date 16Apr2021 12:00 (Lot number: ER8731) as dose 2, single and administered in arm left, administration date 28Mar2021 13:00 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Rapid Test:postive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab.  The patient did not receive any other vaccine in four weeks. The patient developed severe swelling/pain in both axillary lymph nodes starting a few days after 3rd (booster) injection and lasting for 2 weeks. Followed by dull ache in armpits and intermittent pain in hands and feet (most severe in left, injection-side hand) that still persists at time of reporting 2 months after injection. The onset on the adverse events was 23Dec2021. The patient received treatment with 10 day course of Cephalexin 500 mg but was not recovered. The patient had not tested covid positive prior to vaccination. The patient tested positive for Nasal Swab Rapid Test, post vaccination on 18Jan2022.The patient had no known allergies and other medical history.