chrisvoncsefalvay/vaers-outcomes huggingface dataset:
yellow green discoloration below skin; firmer to the touch; A bit headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (yellow green discoloration below skin), MUSCLE RIGIDITY (firmer to the touch), HEADACHE (A bit headache) and FATIGUE (Fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) and MILK OF MAGNESIA for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (yellow green discoloration below skin), MUSCLE RIGIDITY (firmer to the touch), HEADACHE (A bit headache) and FATIGUE (Fatigue). At the time of the report, SKIN DISCOLOURATION (yellow green discoloration below skin), MUSCLE RIGIDITY (firmer to the touch), HEADACHE (A bit headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
The decedent was feeling poorly prior to receiving his first Moderna vaccine on August 31, 2021. Approximately 2 hours after the vaccine, he developed a low-grade fever and body aches.  He left for a trip the same day and  his flu-like symptoms worsened.  He later developed difficulty breathing.  On September 7 or date of death, he developed cold sweats, low grade fever and labored breathing.  He also became disoriented and had trouble walking.  His date of death:  09/07/2021.
Varicella - Information has been received from a health care professional concering a 4 year old male patient who in November 1999 was vaccinated with one dose of varicella virus vaccine live.  In may 2000 the patient experienced breakthrought chickenox.  Unspefied medical attention was sought.  The patient 's two brother waes 00051141 & 00051544 had a similar experience following exposure to varicella virus vaccine live Additional Information has been requested.
2 1/2 x 2cm, right deltoid erythematous, warm. No exudate. Slightly tender touch. Received cool compresses. Rx Zyrtec, Benadryl prn.
large local rxn 2 days p/vax;relieve w/allegra 5-6 days p/vax;
Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event.  appointments for a CT scan. Has mild facial drooping on the side that is already affected by TIA / cerebral hemorrhage.  The long-term or permanent outcome is unknown.
Patient states right arm is painful to touch at vaccine site and has continued pain with movement of arm in any direction.
Started as a bump then more started coming then went to bed woke up with them on hands and legs it keeps spreading.
Information has been received from a physician concerning a 5 year old female patient who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient experienced high fever and developed strabismus. It was also reported that 5 months later, the patient developed shingles. The patient sought unspecified medical attention. No further information is available.
Hospitalization with dehydration, dysphagia, COVID +. No respiratory compromise. Treated with Normal saline 500 ml bolus over an hour and NS @ 100 ML/HR thereafter to hydrate
This spontaneous report as received from a physician concerning a 64 year old male patient who on 16-JAN-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H014196, Exp 29-MAR-2014) (Dose not provided). The physician stated that in approximately 2013 the patient experienced redness and swelling of his arm at the injection site. The patient was evaluated at an unspecified emergency room on 18-JAN-2013 and sent home. The patient was treated with an unspecified antibiotic, TYLENOL and cold compresses. The outcome of redness and swelling of his arm at the injection site was reported as recovering. The relatedness of PNEUMOVAX 23 and the events mentioned above was not provided. Additional information has been requested.
The patient experienced light headed feeling, shortness of breath, and headache. Epi-Pen given and symptoms resolved.
Expired dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (patient tested positive on 30Dec2021) on 30-Dec-2021. Concurrent medical conditions included Blood pressure high since 2020. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure high.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No symptoms were reported after any of the vaccines.  No treatment has been given   This case was linked to MOD-2022-527381 (Patient Link).
I developed a fever and severe muscle pain on July 23 that fully resolved on July 25, followed by a fever and muscle pain on or around August 9. In addition, my menstrual cycle, which has never been longer than 32 days is now 46 days so far and I have had a sunburn sensation on my face, neck and arms for the last three days.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, over last 3.5 years, the patients were vaccinated with (Oka/Merck) VARIVAX that had been improperly stored (0.5 ml; subcutaneous; most current lot information include: lot # J006161 and expiry: 20-MAY-2015; lot# K007979 and expiry: 03-JUN-2016; lot # J012379 and expiry: 03-OCT-2015). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number A2x3y, expiry date 28-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter was health care professional (HCP).   The HCP reported that a patient received an expired dose of Bexsero.   Adverse event (AE) filed. The reporter consented to follow up.
Very sore arm, pain lifting arm up level of shoulder, pain at rest, over 2 weeks since shot and still have pain and soreness.
98 degrees - not noticed until visit 4:00 pm following day Red, swollen, hard (cellulitis) pt jerked during injection (needle reinported) 8.20.09 still red swollen although decrease
2 doses of the firs dose of the Moderna vaccine the same day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (2 doses of the firs dose of the Moderna vaccine the same day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced EXTRA DOSE ADMINISTERED (2 doses of the firs dose of the Moderna vaccine the same day). In February 2021, EXTRA DOSE ADMINISTERED (2 doses of the firs dose of the Moderna vaccine the same day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.  Patient got the second dose at day 28.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Non-significant follow-up document appended.
This spontaneous report was received from a healthcare professional who stated that ZOSTAVAX and VARIVAX were stored improperly and administered to an unspecified number of patients. No adverse effects were reported. Additional information is not expected since reporter did not want to be contacted.
(I am RIGHT-handed and vaccination was in my LEFT arm). Approximately 48 hrs. post-vaccination I started experiencing pain in back of my neck muscles and high back just below my neck. Within additional 12-24 hrs. I also started experiencing pain in my RIGHT shoulder and right upper arm with referred (?) pain down into my right forearm. This pain (with related weakness) was so severe that I could not lift a water glass, hold a toothbrush or paintbrush with my right hand.  Pain was interfering with my sleep and routine daily activities (such as putting on/off clothing). With treatment, my pain has now improved but I still have significant pain in same affected areas.
Fever, joint aches, very flu type feelings of needing to lay down and sleep and of course sore and and a rash where shot went in and below that point of my left arm. Took Tylenol and went to bed as soon as I got home from work Friday around 5:00 pm and slept for 3-4 hours. Went back to bed and slept until around 8:00 Saturday morning. Felt very tired all day Saturday and then on Sunday started coming around a little bit.  So it started severely at 2:00 pm at work on Friday almost 24 hours after I received my vaccine booster and finally started feeling better by Sunday when I woke up.
Dose 1 3/22/2021 007B21A Moderna  Pt died of end stage breast cancer
80YO male who htn, cva, epilepsy, ckd, cerebral avm s/p repair, cad s/p cab, cva (left sided hemiplegia) , hx of prostate cancer recent admission for pna on abx presents to ED on 1/11 with dizziness, hypoxia. CT with Bilateral PE  "Large bilateral pulmonary artery emboli in the right and left main pulmonary artery extending into the right and left main pulmonary artery branches bilaterally. Findings are associated with right-sided heart strain." "Patchy alveolar airspace disease within the lungs highly suspicious for COVID pneumonia" Covid negative. Patients wife recovered from Covid-19 infection within last month. Patent thus far has tested negative. Doppler lower extremity revealed Acute occlusive vein thrombosis of the entire course of the gastrocnemius vein and soleal vein. Patient received covid vaccine on 1/4/21. Patient has several risk factors for clot - age, previous CVA, hx of prostate cancer. Also had positive covid exposure though tested negative
Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). In March 2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication was reported. Treatment medication was not provided.   This case was linked to MOD-2021-103195, MOD-2021-109892 (Patient Link).
Bedridden, severe fatigue, chills, severe muscle cramps and spasms throughout torso and face, face appeared contorted.
Fever,  beginning 11 hours following vaccination, and continuing through the following day.  Treated with Ibuprophen.
Patient passed out 2 minutes after receiving flu shot. She fell hit her head on the counter. EMT's were called. They checked her blood pressure and blood sugar. No allergic reaction to the shot was determined. They believe she had a drop in blood pressure resulting from the stress of the shot.
(Tinnitus) terrible Ear ringing in both ears; Cannot sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration on the left arm on 10Mar2021 at 13:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient was tested for COVID-19, since having the vaccine. On 10Mar2021 at 20:00, the patient had experienced terrible ear ringing in both ears(tinnitus) and was not able to sleep. The patient did not receive treatment for the reported events. The clinical outcome of events tinnitus and sleeplessness were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received on 5/23/02 from an RN concerning a 62 year old female with no known drug allergies who "2.5 months" prior to "last week" and "last week" was vaccinated with the 1st and 2nd dose of pneumococcal vaccine 23 polyvalent, respectively. This dose not comply with the recommended dosage schedule. It was reported that the pt was re-vaccinated since there was a temperature instability issue with the 1st dose. Concomitant therapy the day of the 2nd dose included Hep-B vaccine recombinant (yeast). Within hours, after the 2nd dose, the pt developed a headache, hives, and swelling at both injection sites. The pt sought unspecified medical attention. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: (malaise added to reactions following 2nd dose). It was reported that 30 minutes after leaving the clinic the pt began complaining of headache and tenderness around the injection site. The pt had requested that both injections be given on the same arm due to pre-existing muscle soreness on the right deltoid. By 1:00 PM that afternoon, the pt developed a rash on the left arm and the injection site was swollen about the size of a half dollar. The pt notified her son who is an ER physician. He prescrived diphenhydramine HCl (Benadryl) and ibuprofen (Motrin) for the pain, inflammation and rash, and also moist soaks and elevation of the left arm. It was noted that the pt did not receive any tests with the prescribed treatment. The pt's husband notified the reporter that she had decreased pain and swelling of her left arm and her rash disappeared. It was also noted that the pt had no other adverse events following prior vaccinations. It was reported that the pt recovered on 05/23/2002. No further info is expected.
Evening vaccination was given she experienced chills, body aches, temp-102 and heart rate greater than 150 bpm. Symptoms pretty much resolved next day.
-Extreme Pain in my right cheek/jaw area came on 5 Days after receiving the shot.   Pain was so bad that it would wake me in the middle of the night at its worst, throbbing.  Had to take Motrin and Tylenol every 2-3 hours to get some relief.   Applied Ice packs to my right cheek to help with inflammation.  Severe pain lasted for 3-4 days and as time went on the pain started to subside.  Over all 5-7 days it took for it to stop. -Itchy Red Rash developed 6 days after receiving the shot.   This was on the same arm and location of the shot.  Used Lotrimin to help soothe the itch and the redness went down.  This  lasted for 24 hours or so.   -Had this same reaction after having the actual flu in February of 2019.  I swear the 2019 virus is in this shot.  It is exactly the same extreme pain, same timing of starting the flu and the same timing of it going away, minus the rash.
received notification that patient was hospitalized 06/02/2021 at Medical Center with COVID-19 infection and CVA
chest pain; stomach pain; headache; fever; This is a spontaneous report from a contactable consumer (Patients Mother) reported for son consumer (patient) reported that: A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch number and lot number was not reported) via an unspecified route of administration on 08Jul2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took dose 1 of BNT162B2 (Batch number and lot number was not reported) via unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient experienced slight chest pain, stomach pain, also headache and fever. The patient took Tylenol as a treatment for events this morning at 6am. Outcome of the events was unknown.  Medical Information (MI): Were any medical questions addressed by this program forwarded/referred to Medical Information? YES  Information about Lot/Batch number were requested
One the first day after receiving Dose #2, I ran a low-grade fever all day (99 - 100.6).  On the second day after Dose #2, I woke with swollen lymph node under my left arm; approximately the size of 1/2 orange; it did go down daily; disappearing after 5 days.
7 days after i got the shot i developed a rash on my arm at the injection site. By that evening it looked like a blister. Hot to the touch. Extremely painfull. For five days it slowly spread out into a larger rash. Less blister like. Its now 9 dys after the rash showed up. It is still slightly visible. Tender to touch. And i have a small burning sensation every so often.
34yr old patient with history of obesity, generalized edema, sickle cell trait, HTN, seasonal allergies (on Flonase BID, cetirizine) and other comorbidities presented on 11/23/21 to clinic for well-visit.  PA ordered Pneumococcal Polysaccharide 23-valent (Pneumovax-23) LOT # U010533, administered IM in patient's right deltoid by CMA.  On 11/26, patient presented at OSH with right sided facial weakness. Symptoms started same day with loss of taste on right side of tongue, inability to close right eye. Patient not started on prednisone at ED as per patient "provider could not see her medical history in system".  Patient seen by PA on 11/29 and prescribed Prednisone taper  [576853217].  Pneumococcal vaccine added to allergy list.
inc temp started 1PM APAP given-4PM 103; instructed APAP; 11PM temp 106; called ER took tp to hosp pt flush & lethargic-area swollen, hot not red; next day temp 101-102 pt much better;
Client received the flu vaccine, and approxiamtely an hour later, complained of chest tightness radiating to and under her left breast. Her vital signs were stable, but EMS was called. She was transported to the hospital for evaluation.
Felt warm & gave APAP routinely throughout day; pt began twitching like had no control head to toe; moaning & clinging to mom; felt warmer estimated 103 put into tub & became non responsive; rt ear red;
2 days post vaccine Hep-A, had rash, itching and redness 7 1/2" X 5 1/2" on LT arm possible axillary nodes.
Seen 6/3/19 for vaccine update only no illness, no fever Seen 6/7/19 for fever up to 102 on 6/6/19, 2 episodes non bilious, non bloody, emesis 6/6/19 * Seen 6/15/19 - mom states had 3 minute seizure on 6/14/19 with temp 101 full body twitching, eyes blinking,  repeat temp 100.5  followed by emesis x 2 - hx of febrile seizure at 9 mo old - w stare -> seen in ED
This spontaneous report as received from healthcare worker (medical assistant) refers to a 1 year old male patient with no pertinent medical history and no drug reactions/allergies. On 27-MAY-2014 the patient was vaccinated with MMR II, 0.5 ml, subcutaneous. There was no concomitant drug. About 10 or 20 minutes before the reporter reported, the injection site and surrounding area of the patient was swelled and became red. The patient was given BENADRYL and kept in the office for evaluation. At the time of reporting, the patient was not recovered. No lab diagnostics studies was performed. Additional information has been requested.
The evening that I got my shot I felt the common side effects like flu symptoms. I also had a rapid heart rate and high blood pressure. It woke me up from sleep. My blood pressure remained high and I felt pressure on my chest for three days. Five days after the shot the pressure on my chest felt worse and my blood pressure was still very high, I also have shortness of breath when I am moving around which started three days after the shot. I saw my doctor who ran some tests which were negative. I am still feeling the pressure on my chest and the shortness of breath after one week but it is a little better than it was and less often.
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective; patient had received anti-viral drug Paxlovid as treatment of COVID-19. Treatment start date was 24May2022 and stop date was 29May2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
death I61.9 - Nontraumatic intracerebral hemorrhage, unspecified