chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site swelling, pain, and redness; injection site swelling, pain, and redness; injection site swelling, pain, and redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (injection site swelling, pain, and redness), ERYTHEMA (injection site swelling, pain, and redness) and VACCINATION SITE SWELLING (injection site swelling, pain, and redness) in a female patient of an unknown age 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 PAIN (injection site swelling, pain, and redness), ERYTHEMA (injection site swelling, pain, and redness) and VACCINATION SITE SWELLING (injection site swelling, pain, and redness). At the time of the report, PAIN (injection site swelling, pain, and redness), ERYTHEMA (injection site swelling, pain, and redness) and VACCINATION SITE SWELLING (injection site swelling, pain, and redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
ischemic stroke; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age . No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-JUL-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from an ischemic stroke. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using Company's product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) , the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Ischemic stroke was considered to be disabling and medically significant.
My main adverse reaction is elevated heart rate.  I noticed this about 12 hours after the shot before I was falling asleep, but I seemed fine when I woke up the next day (20 hours post shot).   Then this morning (maybe 40 hours post shot) it was back.  My heart rate is notably elevated with a little shortness so breath (I find myself needing to purposefully take a deep inhale and exhale now and then .)  It has lessened as the day has gone on and now my pulse seems less elevated but I am notable lightheaded/weak.  I had very similar symptoms the Monday following my first dose.  My period started 2 days after my first dose, so wasn?t sure how much of my systems were from that vs the vaccine.  But now, having the same reaction at essentially the same time (2nd day after shot), I?m pretty certain this is a reaction to the vaccine.  (I?ll probably not have my period for another week as my usual cycle is 5 weeks.). With the first shot the problems (elevated heart rate, light headedness) lessened over the subsequent week.  The reaction seems neither worse nor better then after the first shot.  They are very similar in severity.  So my anticipation is this reaction will likely subside over the next week.
On day following, suffered high fever and aches for the following 36 hours.  On Sunday, experienced NSTEMI due to myocarditis (not previously diagnosed) and remained hospitalized for two days following.
This spontaneous report as received from a physician via company representative refers to a 20 month old male patient. On an unknown date the patient was vaccinated with a dose of VARIVAX (lot#, dose, route, strength and indications not reported). The patient appeared to have a developed a "Shingles rash" in November 2013 (now). The patient sought medical attention by office visit. The physician conducted titer tests and was awaiting results. At the time of reporting, the outcome of "shingles rash" was unknown. Additional information has been requested.
arm became hot to the touch around the injection site; arm became hard around the injection site; arm became itchy around the injection site; arm became "red" around the injection site; painful around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm became hot to the touch around the injection site), VACCINATION SITE INDURATION (arm became hard around the injection site), VACCINATION SITE PRURITUS (arm became itchy around the injection site), VACCINATION SITE ERYTHEMA (arm became "red" around the injection site) and VACCINATION SITE PAIN (painful around the injection site) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE WARMTH (arm became hot to the touch around the injection site), VACCINATION SITE INDURATION (arm became hard around the injection site), VACCINATION SITE PRURITUS (arm became itchy around the injection site), VACCINATION SITE ERYTHEMA (arm became "red" around the injection site) and VACCINATION SITE PAIN (painful around the injection site). At the time of the report, VACCINATION SITE WARMTH (arm became hot to the touch around the injection site), VACCINATION SITE INDURATION (arm became hard around the injection site), VACCINATION SITE PRURITUS (arm became itchy around the injection site), VACCINATION SITE ERYTHEMA (arm became "red" around the injection site) and VACCINATION SITE PAIN (painful around the injection site) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported
15 days post vaccine of the (Pfizer Covid vaccine) on 1/6,  I developed a 7 x 5 cm erythematous wheal to left deltoid (injection site) - warm to touch  without puritus/fevers or chills.
Pt came to ER c/o generalized weakness, dizziness, cough, chest congestion, diarrhea, and fever x 2 weeks.
Left axillary pain Swollen lymph nodes left inner arm and armpit Fever Chills Fatigue
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Feb-2022; 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 14-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Feb-2022) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had acute illnesses and chronic and long standing health conditions.     On 14-Feb-2022 at 4:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2022 at 4:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Feb-2022). 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 14-Feb-2022). 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 14-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  This vaccine was administered up until its Mfg Exp date of 04-Apr-2022. Vaccine administration time was reported as 16:15:39. The patient received the booster dose.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Pt recv vax on 11/2/98; on 11/3/98 pt exp inflamed area of LA, fever (101), nausea, body aches; dx=allergic rx to pneumonia vax
Approximately 10 minutes after vaccine she reported she felt hot and was ' having a hard time breathing'. Advised her to take off mask and she vomited on floor.  Had her lie down on gurney. She denied SOB or breath or difficulty breathing BP 118/84 HR 73 02 sat 94% RR 16. After resting for 5 minutes she reported improved nausea, BP 118/84, HR 73, O2 sat 97%, RR 16. Offered small sips of water. Patient rested for 30 minutes with VS monitored every 5 minutes. Patient reported feeling better and denied dizziness, SOB, or with position change. parent instructed to follow up at ER or urgent care if symptoms returned or if concerns.
Patient reports SOB, "very fast heartbeats, wheezing, and sweating" all night. Couldn't sleep. Describes incident as "stressful". Symptoms resolved 3/24/21. Used inhaler for relief that night, did not use OTC, consult PCP, or go to ED. Deferred second dose, physician notes to consider alternative non-mRNA vaccine.
arm soreness; sharp stabbing pains in lower neck; sharp stabbing pains in lower neck and upper back; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER 8730) in the left arm on 31Mar2021 at 15:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no health issues and the patient was very athletic and fit. The patient did not receive any vaccination in four weeks. The patient did not receive any other medications in two weeks. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, post-vaccination, the patient experienced arm soreness, sharp stabbing pains in lower neck and sharp stabbing pains in upper back. The patient reported that initially, she experienced immediate arm soreness. The patient awakened in the middle of the night with sharp stabbing pains in lower neck and upper back. The pain was intense which prevented movement and necessitated contacting physician who prescribed meloxicam and Flexeril. Pain remained intense on second day after the vaccine and persisted on third day but, was considerably improved. The event resulted in doctor or other healthcare professional office/clinic visit. Patient received meloxicam and Flexeril as treatment. The clinical outcome of the events arm soreness, sharp stabbing pains in lower neck and upper back was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt devel hives type rash very itchy 2 wks post vax; tx DPH & Medrol dose pack; Continues on DPH 2 caps q 4 hrs; Dx angioedema;
constantly smell smoke ; I am a non-smoker & do not have any contact with smokers.  I know this is not life threatening but it is very uncomfortable & I have heard people with Covid have had this sensation for months.
Mild fever, chills, headache.  Arm felt like a "dead arm", when someone punches you really hard.  Entire upper arm was/is very sore. Stayed in pajamas all night and the next day but when I showered this morning, noticed that on the inside of the arm it is pink and tender to the touch.  The sore area is approximately 6" long and wraps around from the inside of my arm to the bicep area. There is no tenderness or redness at the site of the injection.
Mom states baby started crying around 6pm (2/28/06) would stop for about 30 mins at a time then start again. Felt hot to touch, but did not take temp. Both legs hot to touch. Eating and drinking ok. Denies SOB. Seizures, limp limbs. Tylenol did help. States baby cried for 2 hrs after first set of shots.
arm swollen; Little soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Little soreness) and PERIPHERAL SWELLING (arm swollen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included METHOTREXATE, FLUCLOXACILLIN SODIUM (FLUCACID), ALPRAZOLAM and SERTRALINE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Little soreness). On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen). At the time of the report, PAIN (Little soreness) and PERIPHERAL SWELLING (arm swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments were reported.
blood clots; Initial information received on 30-Sep-2021 regarding an unsolicited valid serious case from a consumer or non-healthcare professional via social media. This case involves a 42-years-old patient who experienced blood clots (thrombosis) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [frequency, lot number, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious blood clots (thrombosis) (unknown latency) following the administration of INFLUENZA VACCINE.  Thrombosis was assessed as medically significant and was leading to death.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  At time of reporting, the outcome was Fatal for the event blood clots.  The autopsy was unknown and cause of death was reported as clot blood.  There will be no information available on the batch number for this case.; Sender's Comments: The case concerns a 42-years-old patient who experienced thrombosis after the vaccination with INFLUENZA VACCINE (unknown manufacturer). Time of onset is unknown. Further information regarding medical condition at the time of vaccination, previous vaccination and tolerance, other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: blood clots
administered their last pentacel yesterday but it already expired on Monday with no reported adverse event.; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 months old female patient who was administered their last diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] yesterday but it already expired on monday with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2023, the patient received a standard total dose 3 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml (lot UJ737AAA, expiry date- 18-SEP-2023) via intramuscular route in the right thigh for Immunization.  On 19-SEP-2023 the patient was administered their last pentacel yesterday but it already expired on monday with no reported adverse event (expired product administered) (latency- same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient walks up into bleachers seating after vaccination. Other patient witnesses syncope and some tonic clonic activity (brief) alerts RN. RN helps patient to lying position. Patient conscious by the time RN gets to patient (very brief syncopal episode).  During syncope, patient had gotten leg caught under bleacher seat in front of her, resulting in pressure abrasion from below knee to above ankle on shin bone. Patient given ice for leg. Significant other arrives and provides emotional support to patient. Patient diaphoretic. Placed cold towels under neck and on forehead. Patient coherent and laughing and talking to RN. Still feeling slightly dizzy, BP WNL. After ~10 minutes, RN helps patient to sitting. BP still WNL. Patient states she is feeling better, just sore leg. Notes some "stiffness" in hands. Patient stays an additional 10-15 minutes and exits in wheelchair as patient "wants to take it easy" and it is a long walk back to car. Patient stable upon dismissal from observation. Significant other pulls car around and will drive patient home and be home with her. Patient recommended to let provider know about syncopal episode and to elevate/ice leg.
This spontaneous report as received from a Healthcare Worker refers to a patient of unknown age and gender. On 08-AUG-2014 the patient was vaccinated with M-M-R II injection (dose: 0.5 ml, lot number h014647, expiration date 06-AUG-2014) subcutaneous. There was no concomitant medication reported. The healthcare worker reported that the patient received an expired dose of M-M-R II. No adverse effect reported. Additional information has been requested.
Narrative:  Hospitalization: COVID-19 fully vaccinated, incidentally found to be COVID-19 positive upon admission after presenting to ER due to PTC drain dislodgement
Still experiencing upper respiratory congestion; She developed COVID 5 days after getting the 1st dose; She developed COVID 5 days after getting the 1st dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age(reported as Age: 66, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID 5 days after getting the 1st dose, she received the 1st dose on 29Dec2020 and due for 2nd dose on 19Jan2021. The patient was still experiencing upper respiratory congestion. She had the initial dose of the vaccine 3 weeks before and a week after her first dose, she developed Covid, she had been exposed so it just so happened, The patient was 14 days out from having COVID. She was scheduled to get the 2nd dose at the time of the report and was wondering if she needed to postpone it. The outcome of event "still experiencing upper respiratory congestion" was not recovered, of other events was unknown.    Information on the lot/batch number has been requested.
Trouble breathing, bloody and phleme coming from nose, enormous chest pains in the center, chemical taste in my  throat,bumps break out. After 5 months still not well.
Patient's mother stated patient told her she (patient) had symptoms of headache, blurred vision, and faintness within 20-30 minutes after receiving the vaccine.  Patient did not faint, but continued to have a headache for the next 12 hours.
Pt Tested covid positive on 11/21/2021 Pt Admitted to the hospital presented with Cough and fever of 104.0. Pt was treated with Remdesivir.
c/o heat in her body - nausea - left arm tingling & numbness;  symptoms resolved and patient went home.
Upper left arm has became increasingly red, itchy, swollen and hot starting about 2 days after immunizations. Client called on 8/23/01 and was advised to see primary care provider for evaluation. Client reports she was seen in immediate care on 8/24/01. They told her that this was an allergic reaction, put on a course of antihistamine. As of 8/28/01 redness, swelling, have resolved but itching continues.
After 2nd vaccination was given to patient (my son) by nurse following completion of WV by physician. We proceeded to the check out down the hall. As I was speaking with admin staff for a school note, my son whom stood behind me said "Man I feel dizzy as crap". Before I completely turned around I felt his hand attempt to grasp my shoulder and slipped as he went to the ground. I was able to catch his head and ease him there during this spell. He sat on his butt leaning against the wall for several minutes and looked rather pale. Dr. and nurse gave him some cool water and small bag of chips. He was fine after several minutes and ensured me he was okay. After I took him to eat as it is notable to mention that he skipped lunch that day.
Patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. Date of refrigeration was given as 07-MAY-2021