chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain started in left arm then started moving up to neck, headache, down back , hip, leg, feet , complete soreness mainly on left side , thirst , very tired couldn?t sleep during the night 03/30, then felt exhausted and slept most  of the day and pain continued  03/31. Slept all night 3/31. Took Motrin to help  with pain .
Information has been received from a physician concerning a 79 year old female with no past medical history and no drug allergies who on 18-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651400/0618F) (0.5 ml), intramuscularly. On 18-OCT-2006, "a few hours after receiving the vaccination" the patient called the office complaining of pain. The patient stated she was unable to move her arm where the injection was given. At the time of the report, the patient was recovering. Additional information has been requested.
Residents right side of face swelling with 2+edema to lower extremities and bilateral hands, O2 sat 90 with no SOB noted. MD was called and Epi pen was given x1.
Spent 3 days in bed with chills, hot flashes, nausea, aches
Initially felt dizzy (3:15pm).  Had patient sit down.  Lips started tingling. Had patient lay supine with feet elevated (3:30).  Patient started having trouble breathing and could not move her lips and face became flush (3:45), called 9-1-1.
This spontaneous case, initially received from other health professional (nurse) on 02-Oct-2018, concerns a 31-month-old, female child patient. The patient was healthy and had no medical history. The patient did not receive any concomitant medications. On 02-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252661, expiry date: 31-May-2019, route of administration and anatomical location: not reported). The patient did not experience any adverse event after the vaccination. The reporter assessed the case as non-serious.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry : UNKNOWN) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 12-AUG-2021, the patient tested positive for COVID-19 (suspected clinical vaccination failure) as the patient experienced generalised aching, sore throat, fever and was sick as a dog  .  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210826496-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
muscle aches, fever to 101, nausua that started within 3hours of administration and lasted for 5 days+ (still resolving).
mom states child had temp of 104 p/vax;pt had to go to Er & was packed in ice;also was dehydrated;
Soon after, heartrate rose to 110 beats a minute for 24 hours (normal is 60 for me). Stayed very weak in bed all night and next day.
Delayed injection site reaction 10 days after vaccination. Pain, redness, swelling, and heat around injection site.
On the injection site she had a pretty wide area bruised; On the injection site she had a pretty wide area red; On the injection site she had a pretty wide area swollen; Pain from a 1 to 10 scale was 1; The area spread in red color; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (On the injection site she had a pretty wide area bruised), VACCINATION SITE ERYTHEMA (On the injection site she had a pretty wide area red), VACCINATION SITE SWELLING (On the injection site she had a pretty wide area swollen), PAIN (Pain from a 1 to 10 scale was 1) and ERYTHEMA (The area spread in red color) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, NORTRIPTYLINE, METOPROLOL, OMEPRAZOLE and RALOXIFENE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE BRUISING (On the injection site she had a pretty wide area bruised), VACCINATION SITE ERYTHEMA (On the injection site she had a pretty wide area red), VACCINATION SITE SWELLING (On the injection site she had a pretty wide area swollen), PAIN (Pain from a 1 to 10 scale was 1) and ERYTHEMA (The area spread in red color). At the time of the report, VACCINATION SITE BRUISING (On the injection site she had a pretty wide area bruised), VACCINATION SITE ERYTHEMA (On the injection site she had a pretty wide area red), VACCINATION SITE SWELLING (On the injection site she had a pretty wide area swollen), PAIN (Pain from a 1 to 10 scale was 1) and ERYTHEMA (The area spread in red color) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This spontaneous report as received from a consumer with 65 years old male patient with a low heart rate, penicillin allergy and codeine allergy. On 18-JUL-2012, the patient was vaccinated with, 0.65 ml ZOSTAVAX subcutaneously (SC) (lot # not reported). No other co-suspects were reported. Concomitant medications included: ALLEGRA. On 20-JUL-2012, two days after received ZOSTAVAX, the patient experienced shortness of breath. On 04-AUG-2012, the patient experienced lightheadedness and flu-like symptoms. The patient took his own blood pressure and it was 85/50. After calling an ambulance he was admitted to the hospital. The consumer was diagnosed with atrial fibrillation. On 06-AUG-2012, the patient received pacemaker. The patient mentioned that he was still in pain due to the pacemaker surgery, and gets a fluttering in heart. The patient also mentioned that on an unspecified date, he had rash on his shoulder that lasted three days. Numerous heart tests were performed (results not provided). No further adverse event information was provided. The outcome of Blood pressure 85/50, flu-like symptoms, atrial fibrillation, he received pacemaker, pain and fluttering heart was not recovered. Rash on his shoulder was recovered. The relatedness for Blood pressure 85/50, flu-like symptoms, atrial fibrillation, rash on his shoulder, he received pacemaker, pain and fluttering heart was unknown for ZOSTAVAX. Additional information has been requested.
pt had allergic reaction. migraines, swelling of lips and face, itchiness all over body   started 5/11/2021- still occurring today 5/13/2021
C/O feeling achy, weak, headache and warm, no fever, temp 97.
Had an emergency appendectomy on May 9th, 2021. Woke up on Friday the 7th with mild stomach pain from my chest to my belly button. It felt like indigestion. Pain stayed mild until Saturday evening when I started vomiting and had diarrhea and by 11:00 pm I went to the ER where they did bloodwork and a ct scan. Bloodwork showed high white blood cell count, scan showed appendicitis. After 4.5 hours there, I had to leave to go to another hospital and wait for a bed. After being in intense pain for a few more hours, I finally had the emergency surgery at 11:00 am Sunday the 9th.
was sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (was sick) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was sick). At the time of the report, ILLNESS (was sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   Patient received antibiotics from physician for treatment.   This case was linked to MOD-2021-050776 (Patient Link).
2nd dose - lethargic the day after, flu like symptoms only the 2nd 24 hours
injected 0.3ml of childrens covid bivalent vaccine undiluted.  patient was supposed to receive 0.3ml of adult covid bivalent vaccine.  I called pfizer.  conclusion: 0.3ml of undiluted child vaccine is equal to 0.3ml of adult vaccine.  patient received proper dose by chance.
This spontaneous report was received from a clinician via field representative refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 02-SEP-2016, the patient was inadvertently vaccinated with a fourth dose of GARDSIL 9 (dosing details not provided) extra dose administered. Physician reported that the patient received dose 1, 2 and 3 on 14-JUN-1999, 31-AUG-2010 and 09-FEB-2011, respectively (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
BLOOD CLOT IN RIGHT SHOULDER UNDER CLAVICLE; HORMONAL CHANGES; This spontaneous report received from a consumer concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-JUN-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On an unspecified date, the patient experienced hormonal changes in her body ever since got the vaccine and had blood clot in right shoulder under her clavicle. The patient was in the hospital for a week.  The patient underwent blood test and she tested negative for everything autoimmune. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hormonal changes and blood clot in right shoulder under clavicle was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211245202-covid-19 vaccine ad26.cov2.s-Blood clot in right shoulder under clavicle and Hormonal changes. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Here because of swelling right arm. Patient was here yesterday on nurse appointment for vaccines, received influenza vaccine left upper arm, BEXSERO Men B vaccine right upper arm about 420 pm. 4 hours later she developed marked swelling and pain/burning sensation in her right upper arm. Had difficulty moving arm and was unable to sleep because of discomfort. Did not want to take any medication. Applied ice. Swelling a little less today but still present along with discomfort. Able to move arm more. Denies redness of arm, numbness or tingling of hand/fingers. Did not have hives or difficulty breathing. No problem with first dose BEXSERO last month.
Optic neuritis within one week of vaccine - permanent vision loss, eye pain, blurred vision, headaches,etc.
had an arrhythmia; now she has an irregular heartbeat that sent her to the emergency room; This is a spontaneous report from a contactable consumer (patient). The reporter reported two reports for different dose for the same patient. This is the second of two reports.      A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 44-year-old via an unspecified route of administration on an unspecified date (Lot Number: EN6003; Expiration Date: Jun2021) as single dose for covid-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications. The patient previously took first dose of BNT162B2 for covid-19 immunisation and experienced a cough, she was tired and she had body chills; then she was struggling for 2 weeks maybe; then she went to the doctor and she had some kind of upper respiratory infection. The patient experienced an arrhythmia, and she had an irregular heartbeat that sent her to the emergency room. The events start date was 11Apr2021. She was admitted from the emergency room and was sent to be monitored for 24 hours and since then she has had episodes that happen once a week or so. It depends. She was just thinking maybe it was from the COVID vaccine because she has never had problems with her heart. Caller was admitted on 11Apr2021 and was discharged on 12Apr2021.  The outcome was recovering.
Information has been received from a 45 year old female patient, via Pfizer (Source Document # 2016366565), concerning herself. The patient's concurrent conditions included diabetes mellitus, fibromyalgia, osteoarthritis, sacroiliitis , anxiety, depression and sleep disorder. The patient's medical history was not reported. On 27-JUL-2016 at 17:00, the patient was vaccinated with the first dose of PENUMOVAX23 (lot #, expiration date, concentration, dose and route were not reported) in the left arm by a nurse. Concomitant therapies included metformin (lot #, expiration date and concentration were not reported), 1000 mg twice a day per oral route for diabetes; gabapentin (lot #, expiration date and concentration were not reported), 600 mg twice a day per oral route for fibromyalgia; CYMBALTA (lot #, expiration date and concentration were not reported), 30 mg once a day per oral route for fibromyalgia anxiety and depression; and trazodone hyrodchloride (lot #, expiration date and concentration were not reported), 50 mg at night per oral route for sleep. The patient reported that on 27-JUL-2016, between 22:00 and 23:00, she could not move her arm without incredible pain and it hurt so bad that she could not stand it. The patient stated that her arm was sore right after the injection and the pain progressively got worse as the night went on. She said that her arm became warm and swollen about 6 hours after received the injection. The patient stated that it had affected the range of motion, so she could barely pick up her elbow even with her shoulder. She took an ibuprofen 600 mg on 28-JUL-2016 and  her arm was still hurting through that and she was thinking about going to the doctor this same day. There were no laboratory diagnostic tests performed. The patient also reported that she was diabetic and her physician wanted to give her PNEUMOVAX23 to protect her and the physician said she would not need another one until she was 65 years old. The outcome of patient can not move her arm without incredible pain, her arm was sore right after the injection, her arm became warm, swollen, red and the patient can barely pick up her elbow with her shoulder was reported as not recovered. There was not product quality complaint (PQC) involved. Additional information has been requested.
Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Body aches; joint pain; intermittent nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration on Left arm on 04Feb2021 10:15 at single dose for covid-19 immunisation administered at workplace clinic. Medical history included none. The patient's concomitant medications were not reported in two weeks. On 04Feb2021 07:30, patient had Body aches, joint pain, and intermittent nausea. These symptoms started approximately 8 hours after the shot and persisted for 48 hours. The patient not received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021232169 same reporter/patient/drug, different time/event
mild, positive local reactions; Initial information received on 04-Jan-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who experienced mild, positive local reactions while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation: suspension for injection, strength, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious mild, positive local reactions (localized skin reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported"We needed to skin test a patient to the flu vaccine that we suspected had egg allergy. We used one of our doctors and her nurse as controls who we know are not allergic to egg. They both had mild, positive local reactions-We are brain storming what we may have done wrong and also are looking into what the differences are between >65 quadrivalent and regular quadrivalent vaccines. The doctor is also asking what the inactive ingredients are. This case has been created for Nurse Separate case has been created for unknown number of people for positive skin test."  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event non-serious mild, positive local reactions  At time of reporting, the outcome was Unknown for the event non-serious mild, positive local reactions
8-3-12 Mother reports pt has a fine, raised, red rash over entire body which started on 8/1. Reports pt seen 2 days prior, for viral infection et high temp. by doctor. Didn't know if rash was from shots or viral infection. Denies itching or difficulty breathing. Referred to doctor.
fever  high of 102, chills, body aches, headache, heat rash on stomach, dizzy, nausea - for two days (102 fever on 2nd day)
Muscle aches, flue like symptoms, diarrhea, very tired, and sever body sweats. Symptoms lasted about 60 hours and was self treated at home. This was the sickest I have felt in about 10 years. I am a healthy person with no other known medical conditions.
1/12/21 first vaccine dose. Delayed reaction. Similar to a weak reaction to allergy shot. no issues 2/16/21 second vaccine dose. 7am: vaccine administered. Could feel in muscle 8-9am: could feel swelling deep in muscle.  No visible swelling at shot site. 9-12noon: could feel vaccine swelling / pain radiate down the arm to the elbow and below 3:00 - 4:30 pm start feeling neck and buttock pain 6:00 pm - neck and buttock pain becomes more pronounced. 8:00 pm - ibuprofen taken 200 mg 4 tablets 2/17/21 4:45 am pain spread throught body 5:30 am pronounced muscle, joint pain 5:45 am ibuprofen taken 200 mg 4 tablets sleep 11:00 am continued deep muscle and joint pain 11:00 am naproxen liquid gel 220 mg 3 capsules sleep 5:00 pm some reduction in pain 8:00-9:00 pm Full On Body Rash 8:00 pm ibuprofen 200 mg 3 tablets sleep 2/18/21 5:00 am still have full on body rash. pain reduced 7:00 am arrive to work. Fatigue. 4:00 pm leave work. Nausea. 5:00 pm Home. Nausea. vomiting. Take Nauzene 2/19/21 Itchiness begins. Benadryl Taken. Body Rash fading 2/20/21 symptoms begin to subside 2/21/21 itchiness resumes.  Very Annoying. Change of clothes finds pustules all over abdomen and back. broken pustules likely from scratching
A nurse reported that her 2 month old daughter received her 1st dose of Prevnar on 8/17/00. On 8/20/00, the infant developed "watery", "rip-roaring" diarrhea. The mother indicated that as of 8/31/00, the infant was losing weight and diarrhea continued, despite changing the infant's formula twice. On 9/5/00, the infant developed a fever of 101F and reportedly, a dx of ear infection was made. The infant was treated with amoxicillin. On 9/7/00, the fever "diminished". The mother stated, "My doctor feels this occurrence could be related to the Prevnar".
1 minute after administration of vaccine, patient lost consciousness and fell from chair striking the right side of head on pavement. He was rolled from prone, assessed and had a pulse but initially was not breathing. 911 called Within 10 second, had spontaneous return of respirations, consciousness and was oriented to person, place, time. Sustained an abrasion to his head, complaints of mild HA, no neck pain or signs of cervical injury or other trauma. Vitals monitored. Given fluids, juice. Assessed by paramedics and refused transport to ED for further evaluation. Given ice and called a friend for a ride home. Observed for nearly 1 hour after LOC and had returned to baseline mentation. Advised to call 911 or go to ED if worsening of HA, vision changes, confusion, falls, nausea, vomiting due to concerns for head trauma. Assessment is that this was likely a vasovagal episode and patient reported similar experience with immunization in past, in retrospect. Discussed that this is not a contraindication for 2nd dose but that he should be sure he is well hydrated and advise healthcare providers of history of vasovagal with first dose. The county will work with him to schedule 2nd dose at a health clinic attended by EMS (on site).
Extremely heavy period, abnormal cramping, migraine, fatigue, backache. All more severe than standard.
Left sided facial numbness, facial twitching near corners of mouth, left sided headache, then mild facial droop with smiling noted
Patient is fully vaccinated and boosted on 8/30/2021.  COVID + 1/12/2022 and admitted to hospital on 1/18/2022.  64-year-old male with history of bipolar affective disorder, diabetes, colorectal cancer, and end-stage renal disease requiring dialysis is brought to ED due to generalized fatigue.  Patient states that he "does not feel well" and admits to mild shortness of breath but denies any chest pain, abdominal pain, nausea, vomiting, constipation, diarrhea, dysphagia, dysarthria, diplopia, or ataxia. HG 7.4. 1 unit PRBC given. PLts 135. CXR: Pulmonary mass within the right lower lobe with associated mediastinal adenopathy concerning for neoplasm with metastatic disease. Occlusion of the right lower lobe segmental bronchus. Recommend appropriate oncologic follow-up. Pnuemonia due to COVID:  IV decadron, Breo inhaler, albuterol, IV remdesivir. Resume dialysis.  Discharged stable to skilled nursing facility.