chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On January 26, patient lost his balance and fell, no injury.  On January 28, patient, fell, no injury.  In both cases falls were observed and were not to the head.  On January 29 patient could not maintain his balance.  Taken to  hospital.  MRI revealed large subdural hematoma.  Craniotomy on January 30, by Dr.  Approximately 10 days later, Hbg, was down to 7, unexplained internal bleeding.
pt recv vax SEP95 & OCT95 it was reported that pt began to exp shock-\like, burning sensations all over body;pt is hypersensitive to pain, wears special shoes & socks & can't lay down in bed w/o extreme pain described as intense;
Syncope; things went dark; almost passed out twice; BP spikes; left arm pain at the site of the injection; fatigue; A spontaneous report was received from a Consumer concerning a  71 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced  almost fainted/presyncope, Fainting/Syncope, Blackout/Loss of consciousness, Injection site pain, BP spikes and Fatigue.  The patient's medical history was provided as Atrial Fibrillation, Syncope and Diabetes (borderline). Relevant concomitant medications were reported as Warfarin, Cimetidine, Carvedilol, Spironolactone, Glipizide, Magnesium, MiraLAX, Probiotics, Stool softener and Clonidine PRN.    On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, after receiving the first Moderna Covid -19 Vaccine the patient experienced dizziness, increased heart rate, left arm pain at injection site. She reported of "almost passed out, and things went dark" on day 4 (02FEB2021) and day 5 (03FEB2021) after the vaccination. She reported that she had one syncopal episode 02FEB2021 while she was standing around the stove, and 2nd syncopal episode occurred on 03FEB2021 while she was getting out of shower. She also has mild fatigue since the vaccination. Fainting and Blackout were medically significant.  Laboratory details were provided by her BP readings which are as follows:  BP reading on 02MAR2021 -- 102/56, 168/69, 103/54 BP reading on 03MAR2021 -- 180/90, 193/75, 201/91, 215/115 (took Clonidine) BP reading on 04MAR2021 -- 176/81, 200/87 BP reading on 06MAR2021 -- 200/90, 220/92 (took Clonidine) She checked her blood glucose levels daily, and its "within normal" limits. Treatment details was provided as Clonidine PRN.   Action taken with mRNA-1273 in response to the events was unknown.  On unspecified date, the outcome of the events injection site pain was Recovered/Resolved. At the time of this report the outcome of the events Fainting, Blackout and Fatigue were unknown.; Reporter's Comments: Based on the information provided, the established safety profile of mRNA-1273 vaccine and a strong temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Injection site pain and Fatigue are consistent with the safety profile of the vaccine.
EXCESS SWEATING; PAIN AND SORENESS UNDER ARMS; FEELING REALLY BAD AND LIKE A TRUCK RUN OVER HER; FEELING CRAPPY / FEELING ABNORMAL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced feeling crappy / feeling abnormal. On an unspecified date, the subject experienced excess sweating, pain and soreness under arms, and feeling really bad and like a truck run over her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling crappy / feeling abnormal, and the outcome of feeling really bad and like a truck run over her, excess sweating and pain and soreness under arms was not reported. This report was non-serious.
Temp 105- no other focus. 2cm area of erythema, swelling left thigh.
Headache Fatigue Soreness at Injection Site Swollen Lymph Node Chills
I got the vaccine on Saturday, 4 /3/21.  Not sure if this is a reaction from the vaccine or just something new I've developed in the last couple days.  Tuesday afternoon (4/13/21), I was feeling twitching around the outside corner of my right eye/cheek area.  I didn't pay it any attention.  Wednesday morning it was happening again.  I started paying attention after a couple times.  It feel s like someone has a string from the top of my head area that passes down the outside corner of my right eye, down my cheek, to the outside corner of my mouth; then starts tugging on the string.  Also, a pain starts in the lower part of my head, behind my right ear.  It's happening more often, to where I'm getting annoyed with it.  I got an automated call about the  vaccine; if having any (insert list of symptoms) please contact your doctor or clinic.  I contacted my doctor, she suggested I report as an adverse reaction, just in case, and to get checked out in the ER.  I have not yet gone in.
Patient was administered the incorrect vaccine to complete their primary series. No initial treatments requires, not observed outcomes nor signs of distress.
Subdural hematoma chronic  with bleed for 3 weeks since about March 12, then acute subdural hematoma on April 2. Required EMS, had a seizure during transport, and required a craniotomy with evacuation  on April 2 within hours of the second vaccine m.
Severe swelling of arm & torso. Arm swollen from mid forearm all the way to shoulder & axilla. Upper left back and torso down to lower ribs also swollen. All of the swollen area painful. Upper arm from elbow to shoulder mildly red. Bullseye-like rash at injection site, about 5cm in diameter. Peak swelling & redness from 24-36 hours after injection. Still reducing but very slowly.
Participant received a flu shot and while waiting for the reaction, started complaining of heaviness in both arms. Call made to EMS waited for the ambulance, participant stated "feeling better." Monitored by nurse, EMS took vitals BP 130/80, P 85 reported. Bipolar, depression, axienty disorders. Glucose 88 mg/dL, less than 2 second capillary refill.
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt. woke up the next morning after vaccination and "didn't feel well", described by wife as fatigue, no energy.  At approximately 2 PM, he vomited.  His wife checked on him at 4:20 PM and he wasn't breathing sitting in his chair.   EMS squad was called but when they arrived he was asystole and mottling present.  Did not start CPR since he was already gone too long.  Pronounced by coroner on scene.
I couldn't function for two days after the vaccination. I was weak, achy, and felt horrible. I didn't take any medication. I got better and promptly forgot about it.
Colors and spots being seen. Did not hit head, pale, unable to answer.  HR 97, BP 142/80 Pt drank water, color is appropriate. Awake and oriented x2 Denies allergies, medications and PMH
Pt has redness running down the arm all the way to the wrist and arm is swollen.
Rash at injection site; A spontaneous report was received from a 73-years-old  female patient  concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event rash at injection site.  Treatment details included not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, rash at injection site was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086228:1st dose
Rash, exanthem-like morbilliform eruption on trunk and proximal extremities 2 days after receiving vaccine. Has continued 3 weeks out. Primary symptoms are rash and pruritus.
Under skin rash-from top of shoulder through center of breast-body rash-arm rash
PT HAD LOCAL REACTION CONSISTING OF PAIN, SWELLING, INCREASED WARMTH, NOT INDURATION OR LUMP AND ITCHING.  AFFECTED AREA EXTEND AROUGND ARM, HALF TO ELBOW.  PT TIRED AND SLEEPY;LOOSE STOOLS.ILLNESS LASTED 7 DAYS.
Cellulitis, to whole upper arm.  Wrapping completely around w/ Lymphadnopathy starting in lymph nodes under the arm.
Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of (Pfizer/BioNTech COVID-19 Vaccine, Solution for injection, and expiry date: not reported) via an unspecified route of administration in the region of left arm on 09APR2021 at single dose for Covid19 immunisation. Medical history of the patient was reported as cataract, which the patient had for over a year and Left eye surgery for cataracts. The patient's concomitant medication was not reported. The patient had cataract surgery in the left eye on 20Apr2021, the outcome of which at the time of observation was reported as recovered. On an unspecified date after the vaccination the patient experienced soreness in the left arm that went away in 4-5 days. The outcome of the event soreness in the left arm was unknown.  No follow-up attempts are needed. No further information is expected. .
?Covid Arm? 7 days following injection a firm, erythematous area developed and has grew to about 12*10cm. She had an appointment with her oncologist (routine follow up as a 4 year breast cancer survivor) and was prescribed clindamycin believing it was cellulitis. No improvement with antibiotics and today she was prescribed triamcinalone cream and will take a Benadryl tonight. It remains itchy and slightly painful.
Headache that intensified through the evening.  Focus in activities was diminished; thinking was dulled.
Patient developed a rash that occurred 2 days after administration. Patient woke up 2 days later extremely itchy and a rash localized on the right arm which was the one where the vaccine was given. Rash is improving today 3/5 but still present. No severe side effects noted.
Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient 30-Aug-2022/Expired vaccine stored in refrigerator; No adverse event; Vial was expired on 13-Aug-2022, and administered to the patient on 30-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient 30-Aug-2022/Expired vaccine stored in refrigerator), EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (first dose), COVID-19 Vaccine (First booster dose) and COVID-19 Vaccine (second dose). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 30-Aug-2022 at 11:54 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 30-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient 30-Aug-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient 30-Aug-2022/Expired vaccine stored in refrigerator), EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient 30-Aug-2022/Expired vaccine stored in refrigerator) and EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 30-Aug-2022).    No relevant concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 13-Sep-2022, vial was removed from the freezer and placed into the refrigerator on 12-Sep-2022. The vial did not undergo any temperature excursion.  No treatment information was provided.
School called patients mom at 1:25 and said patient was running a fever of 102.
Woke up in the middle of the night; Pain in the legs; Blood on toilet paper when wiped; Fever; Joint pain; Muscle pain; Uncomfortable; Chills/Shivering; Pain on the Injection Site; A spontaneous report was received from a consumer concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, discomfort, injection site pain, fever/pyrexia, sleep disturbance/sleep disorder ,bleeding/haemorrhage, joint pain/arthralgia, myalgia/muscle pain, pain in extremity/pain in leg.   The patient's medical history was  as cloudy urine prior to vaccination .No  Concomitant medications were reported.   On 04 Feb 2021,the patient  received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in an unknown location  for prophylaxis of COVID-19 infection.   On 04 Feb 2021 ,night after receiving the vaccine the patient developed chills, was uncomfortable and had little pain in the injection site. On 06 Feb 2021 in the middle of night the patient started shivering, chills and fever to a temperature of 101.4.The patient also noticed bleeding when she went to bathroom. But there was no pain or burning sensation on urination. The patient also experienced muscle  pain, joint pain and leg pain as well. Event Blood on toilet paper when wiped was considered medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The events, chill, uncomfortable and little pain on injection site were considered recovered on the days 05 Feb 2021.And the events fever bleeding ,muscle pain, joint pain and leg pain were considered unknown; Reporter's Comments: This case concerns a 45 Y/O F with a serious unexpected hemorrhage and nonserious unexpected discomfort, sleep disorder, pain in extremity, and expected vaccination site pain, pyrexia, chills, arthralgia, myalgia.  Event onset the same days as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Moderna COVID-19 Vaccine EUA. New onset leg pain started within days after 1st dose of vaccine. Leg pain is hindering patient's ability to walk. Patient is on Enbrel therapy for rheumatoid arthritis. Patient reported some relief in symptoms shortly after dosing Enbrel (50 mg SQ every week). Referred patient to physician prescribing Enbrel.
NUMBNESS ON LEFT ARM; FEVER; HEADACHE; NAUSEA; BODYACHE; This spontaneous report received from a patient concerned a 41 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced numbness on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyache, fever, headache, and nausea on APR-2021, and the outcome of numbness on left arm was not reported. This report was non-serious.
24 hours after ROTATEQ given developed diarrhea, vomiting & irritability. Diarrhea & vomiting lasted from Mon - Wed but has remained irritable.
Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Rash on her neck and upper chest and under her breast; Sore Left Arm Post First Dose; Tired Post First Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm Post First Dose), RASH (Rash on her neck and upper chest and under her breast) and FATIGUE (Tired Post First Dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 030L20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event .    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm Post First Dose) and FATIGUE (Tired Post First Dose). On 09-Jan-2021, the patient experienced RASH (Rash on her neck and upper chest and under her breast). On 07-Jan-2021, PAIN IN EXTREMITY (Sore Left Arm Post First Dose) and FATIGUE (Tired Post First Dose) had resolved. On 10-Jan-2021, RASH (Rash on her neck and upper chest and under her breast) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided    This case was linked to MOD-2021-047747 (Patient Link).
Breast pain, severe fatigue, severe headaches, missed menstrual cycle followed by extremely heavy and long menstrual cycle
Patient was given a high dose flu shot when they should have received an influenza vaccine for under 65.
Later the day of her shot, she reports that her tongue and lips became swollen and she had difficulty breathing. She stated that "I felt exactly how I feel when I'm around shellfish." I advised her to see her MD and to not receive the second dose of the vaccine.
pt driving home p/vax @ bank passed out & ran through fence & hit house p/getting dizzy, then was awaken by home owner unaware of happenings;
swelling of muscle @ inj site of moderate degree (apparent muscle swelling w/o abscess or cellulitis)/pain;
Patient presented with dizziness, headache, felt "heavy" and shaky. Patient had just received a dose of Moderna vaccine. She was offered juice. EMTs were called, and they recommended that the patient be monitored for an extra 15 minutes. Patient's vital signs were taken (below). Patient was released to go home by paramedics at 12:32pm.
15 hrs after injection Nerve pain (burning) throughout the body, 9/10 pain, lasting for 12 hrs. 24hrs after injection, joint pain in shoulders and hips, lasting 8hrs. 72 hrs after injection, red/hard/painful/itchy rash at injection site still occurring as on 2/15/21.
Sore arm; itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching). The patient was treated with TALC (BABY POWDER [TALC]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified thyroid and high blood pressure medications.   This case was linked to MOD-2021-135592 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05 May 2021.Added second dose details and updated outcome of events.
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: At this point in time, patient was taken by paramedics and they took him to the local hospital. Additional symptoms,issues, or outcome unknown.
Out of nowhere my arm is killing me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Out of nowhere my arm is killing me) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Out of nowhere my arm is killing me). At the time of the report, VACCINATION SITE PAIN (Out of nowhere my arm is killing me) outcome was unknown.            Reporter did not allow further contact
I developed a rash during the week after my vaccine. One week later the rash became severe and very uncomfortable and swollen. I went to the doctor where they drained the sores and took a culture. The results came back I have a staph infection and MSRA
dizzy, warm, BP 145/72;T97, P104 12:03, P80 12:13;
Patient developed paralysis in half of face about 1 month after Moderna COVID vaccine dose 2.  She was evaluated at urgent care facility, diagnosed with Bell's palsy, and treated with steroid injection.
Increasing redness, swelling, warmth which extends from the elbow to the shoulder.  No fever.  Mild pain. Diagnosed with cellulitis and started on Clindamycin.  Asked to follow up with the primary doctor in 2 days.