chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the arm was a little sore (3rd shot); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm was a little sore (3rd shot)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE, AMLODIPINE, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), ACETYLSALICYLIC ACID (ASPIRINE) and ESOMEPRAZOLE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (the arm was a little sore (3rd shot)). At the time of the report, PAIN IN EXTREMITY (the arm was a little sore (3rd shot)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported.   This case was linked to MOD-2021-331310 (Patient Link).
patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old female patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 17th August 2022, the patient received Havrix. On 17th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: The nurse reported that a patient received an Havrix which was expired on 9th Aug 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
This spontaneous report was received from a physician via social media refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date the patient was vaccinated with GARDASIL (lot# and expiry date unknown) (dosing details, lot# and expiry date unknown) for prophylaxis. On unknown dates, the patient experienced an unspecified adverse event, unspecified illness, unspecified chronic condition, poor concentration, extreme tiredness, dizziness, pain in joint and pain in muscle. The patient was hospitalized due to the unspecified adverse event. The outcome of the events were unknown. Causality assessment was not provided. The reporter considered adverse event (NOS) to be life threatening. This is one of the three reports received from the same reporting source.; Sender's Comments: US-009507513-1810USA002766: US-009507513-1810USA003394:
Fatigue beginning 2 hours post injection. Fever beginning 6 hours post injection, maximum temperature 102 degrees, treated with ibuprofen after having a fever for 24-hours. Muscle ache and joint pain coincided with fever. Extreme soreness at injection site extended down to elbow and into shoulder. Headache beginning 10 hours post injection. Symptoms largely went away 30 hours post injection after taking ibuprofen.
PT WITH FEVER,CONGESTION, STOMACH ACHE. MOM REALIZED THAT PATIENT HAD RECEIVED FLUMIST IN OUR OFFICE ON 10/02/2009 AND THEN RECEIVED THE H1N1 MIST AT SCHOOL THROUGH THE HEALTH DEPARTMENT ON 10/16/2009. MOM HAD SIGNED PERMIT TO GIVE AND ANSWERED THE QUESTION ABOUT LIVE VACCINE IN THE LAST 30 DAYS INCORRECTLY.
Side heat at injection site; Swelling at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Side heat at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00813) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced INJECTION SITE WARMTH (Side heat at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INJECTION SITE WARMTH (Side heat at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient denied to contact PC.
Patient arrived and stated she had an appointment for COVID-19 vaccine #2. After the vaccine was administered, the vaccine card to stamp the date/lot number on it. It was then realized the Pfizer was given to the patient instead of Moderna (which was her first dose on 1/15/2021. She then had a consult with a Physician, waited 15 minutes, and then went home for the day without incident. Follow-up call make to patient on 2/18 to review stability post vaccine, which she confirmed to be feeling well on this date.  Internal processes for member check-in and vaccine history reviewed, revised as result of the above.  All patients presenting for vaccine will have their vaccine card reviewed prior to 2nd vaccination.
1/5/21 @8AM: Immediate soreness at site of injection. Unable to sleep through night after injection  ~1/6/21 @3:30AM: woke up with chills and sweats
pt had a recent hospital admission (facility unknown) for poor oral intake, cough, congestion; dx with UTI, non-STEMI; family opted to pursue hospice care with comfort as the goal; admitted to Facility on 1/25/22; pt tested positive for COVID on 1/26/22; given O2 supplementation, dexamethasone and doxycycline; pt expired in the nursing home; med records and death certificate submitted per VAERS request
Itching, redness, swelling, pain, rash at the site. It started itching before bedtime on the day the vaccine was given. Patient sought emergency treatment since her Dr or urgent care were not open. They gave her pain medication and a BENADRYL.
24 YOM AOX4 pt after taking vaccine pt had a syncope episode. pt did not hid head on episode. pt was held up by friends and staff. pt was breathing. pt past out for less than a minute and regained consciousness. pt after episode was alert and oriented to person place time and event before and after episode.  pt stated that that this was a common event every time he was stuck by needle or given a vaccine. during episode EMS was called and was given report. pt was AOX4 and was able to decline EMS services. pt was told that if he felt bad or got worse that he should call EMS at any time, pt gave expressed certification.  pt vitals BP of 110/56 Pls 58 SPO2 98 R18 after patient Declined EMS services pt was set free to leave.
Absence seizure lasting a minute, could not walk, unaware of surroundings, no treatment.
pt recv vax & 3wk p/vax pt devel a mild rash;
Spondylitis ankylosing aggravated; Drug effect decreased; Cold; Infection; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated), THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), NASOPHARYNGITIS (Cold) and INFECTION (Infection) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.  Concurrent medical conditions included Ankylosing spondylitis.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated), THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), NASOPHARYNGITIS (Cold) and INFECTION (Infection). At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) had resolved and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), NASOPHARYNGITIS (Cold) and INFECTION (Infection) outcome was unknown.  The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medication was reported. No treatment medication was reported.  Company comment: This is a spontaneous case concerning an adult male patient with medical history of Ankylosing spondylitis, who experienced the unexpected, non-serious adverse event of special interest of Ankylosing spondylitis (Spondylitis ankylosing aggravated), on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported to have the Adalimumab stopped working for 2 months causing ankylosing spondylitis flares. Date of vaccination, clinical course, diagnostic tests and other treatment details were not provided in the case. Medical history of Ankylosing spondylitis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of Ankylosing spondylitis, who experienced the unexpected, non-serious adverse event of special interest of Ankylosing spondylitis (Spondylitis ankylosing aggravated), on unknown date after receiving a dose of mRNA-1273 vaccine. The patient reported to have the Adalimumab stopped working for 2 months causing ankylosing spondylitis flares. Date of vaccination, clinical course, diagnostic tests and other treatment details were not provided in the case. Medical history of Ankylosing spondylitis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient was given PEDVAX HIB, should have been MCV4, we have MENVEO in the office.
Neck down to waist, on sides. Mostly on neck. Hot, red, bubbly; hands, face not affected.
After 10 minutes of observation,  patient reported to staff that her hand felt numb with some tingling sensations. No issue with breathing. After a further 5 or 10 minutes the patient said both hands felt numb and started tingling.  We offered to call EMS for patient but she said her brother would pick her up and take her to urgent care.
Information has been rec'd regarding a case in litigation which concerns an approximately 5 yr old male pt who on 7/25/96 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was reported that less than a year form the date of 11/01/01 the pt was first diagnosed and discovered to have mercury poisoning and related severe mental and physical injuries. Upon internal review, mercury poisoning, severe mental and physical injuries were determined to be other medical events. No further information is available.
After the second dose my chest started to feel very tight at first. Yet, it progressed to my right calf. I  was experiencing very severe pain in my right calf. I thought the pain will eventually go away yet it still continued. About three weeks after my second dose, May 24th, I drove myself to a local clinic, and they directed me to the emergency room to get a X-Ray of my right calf. They found a blood clot. The doctors bandaged my calf and prescribed me Xarelto to treat the pain. In addition to the prescription, they directed me to a Vascular doctor to documented the recovery. As of now it is unclear if the blood clot is completely gone, however, my calf is still swollen. In addition to that, my little toe and the heel of my right foot is numb to any sensations.
Dizziness; Upset stomach; Horrible headache; Chills; Body aches/hurts everywhere; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Horrible headache), CHILLS (Chills) and MYALGIA (Body aches/hurts everywhere) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 immunization.     The patient's past medical history included COVID-19 in December 2020.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Horrible headache), CHILLS (Chills) and MYALGIA (Body aches/hurts everywhere). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Horrible headache), CHILLS (Chills) and MYALGIA (Body aches/hurts everywhere) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-036065 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09-JUL-2021 and contains NNI
Information has been received from a physician concerning an 84 year old female with drug hypersensitivity to codeine who was vaccinated on an unspecified date with zoster vaccine live (Oka/Merck) (Lot # and dose were not specified). Concomitant therapy included ramipril (ALTACE), atorvastatin calcium (LIPITOR), acetylsalicylic acid (ASPIRIN), lansoprazole (PREVACID), sertraline HCL (ZOLOFT) and acetaminophen (TYLENOL). The physician reported that on 06-APR-2008 the patient developed burning pain on her chest wall and mild erythema at injection site. No rash was present. The patient was seen by the physician. At the time of this report, the patient had not recovered from burning pain on her chest wall and mild erythema at the injection site. No further information is available.
onset of fever t102-104 10MAY04, pain @ site of IM inject leg; temp inc to 106 in ER 12MAY94;
This patient was admitted to Hospital on 1/5/2022 for COVID related symptoms. This is considered a breakthrough case.
Swelling of left leg, vomiting X 2, very fussy, fever 102.5F (ax).
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Fever and myalgias for 2 days.  Observation, tylenol and hydration.  Full recovery
Severe flu-like symptoms, fever, chills, muscle pains, headache, exhaustion.  Symptom onset about 6 hours after injection and lasted for about 2-3 days.
Information has been received from an office manager concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 06-DEC-2016, the patient was vaccinated with GARDASIL (lot # K001500, expiration date 06-NOV-2016) (strength, dose, frequency, route were not reported) for prophylaxis. No adverse effects was reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and concomitant medications were not reported. On an unknown dates since 11-MAY_2015, the patients were administered unspecified number of improperly stored doses of ROTATEQ(dose not reported, orally, lot # K013661, expiry date 26-MAY_2016; lot # L0044533, expiry date 27-MAY-2015; lot # K016314, expiry date 05-JUN-2016; lot # L000425, expiry date 21-JUN-2016). It was unspecified which lots were administered to which unspecified patients. No adverse effects were reported. Additional information has been requested. This is one several reports from the same reporter/
Patient received moderna vaccine on 3/18/21, 4/15/21 and pfizer vaccine on 12/23/21. Presented to ER on 6/11/22. Admitted due to fall. COVID test not done until 6/13/22 which was found to be COVID positive. She had mild hypoxia, which may be related to CHF as she was receiving fluids for rhabdomyolysis.  She was started on remdesivir, steroids, she was also treated for community-acquired pneumonia. On room air starting 6/18/22 so remdesivir was stopped. Patient was discharged on 6/21/22
1/20/2021   Started about 430 PM. Headache , muscle ache, nausea. That lasted about 4 to 5 hours. Headache lasted until the next day till about 430 PM
She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn't itchy.
fever, chills, widespread acute pain in entire body, nausea , stomach pain .  Pain so debilitating that I couldn't move around. The symptoms are continuing into second day. It's as if I was given a virus. Because I have autoimmune diseases, I am usually cautious about live vaccines. However, because I was told this wasn't live, I thought it would be similar to a flu or pneumonia vaccine. It is not. I am incredibly ill
This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 59 year old patient(gender unknown). The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 24-MAY-2013, one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). At the time of this report(01-JUL-2013), the patient had not yet received dose 2 of RECOMBIVAX HB. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Patient felt flush 10 minutes after vaccine. Onsite EMS was called vitals BP 118/81  HR 91 100% O2. Benedryl was given monitored for 30 minutes. Patient was treated and released against medical advice.
An hour after getting the injection my left arm started spreading red, the next day I woke up with a terrible migraine, more redness and hives, it feels like a bad sunburn. My skin is red all over my body.  I didn?t ever feel pain at the injection site just felt warm as the vaccine spread.
pt made a noise mom went to bedroom & pt was blue; pt cried loudly; mom held pt up thinking pt was choking & then pt jerked sharply 2 times; pt taken to hosp;
Patient left facility and returned after having left with complaints of tingling of mouth/throat. Patient developed cough and stridor. Epinephrine was administered and patient was transferred via EMS to ER
Severe cramps in legs, chest, throat, chronic pain in and stiffness in lower joints. Shooting pain in groin. unable to walk correctly and keep balance
Weakness, pain in legs, hips and neck, heart racing. There was no improvement Sunday. Today pt coughing, had fever, still weak. Pt currently away from since he is a truck driver. Reporter stated pt has not had problems with Flu vaccine before.
Severe L shoulder pain x 3 weeks with limited range of motion; presumed bursitis.
Dizziness 3 days after 1st vaccine shortness of breath prior to 2nd dose worsened after 2nd dose.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 at 16:45 as dose 1, single (Lot number: EM9809), in left arm, on 11Mar2021 at 16:00 as dose 2, single (Lot number: EN6205), in left arm, on 14Oct2021 at 17:00 as dose 3 (booster), single (Lot number: EW0172), in right arm and on 21Apr2022 at 17:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; OMEPRAZOLE; MEMANTINE; MAGNESIUM CITRATE; PSYLLIUM [PLANTAGO AFRA]; TURMERIC [CURCUMA LONGA RHIZOME]; TESTOSTERONE; CALCIUM CARBONATE; VITAMIN D [COLECALCIFEROL]; GLUCOSAMINE; CHONDROITIN; VITAMIN D 3; OMEGA-3 FATTY ACIDS; FISH OIL; DICLOFENAC SODIUM. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 20May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Covid symptoms 18May. Tested positive AM 20May. Took first dose of Paxlovid PM 20May. Symptom free AM 25May. Felt great until PM 28May. Strong positive test. Laid out with Covid as of 29May. No known allergies.   No follow-up attempts are possible. No further information is expected
pt recv vax 11MAY97 & 15 days post vax pt devel paralysis of lower extremities;pt taken to clinic dx of transverse myelitis made;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-NOV-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J005068, expiration date 18-JAN-2015) (dose and route unknown) which was exposed to an unsupported temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.