chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Shaking; Sore arm; Fever of 102.6F; Headache; Chills; A spontaneous report, was received from a nurse, concerning a 38 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced body aches (pain), sore arm (injection site pain), shaking (tremor), fever 102.6 (pyrexia), headache, and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K29A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 30 Dec 2020, at about 9 am, the patient experienced shaking, chills, fever 102.6, headache, body aches, and sore arm. Treatment for the events included acetaminophen and ibuprofen and fever got subsided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event, fever 102.6, was considered resolved on 31 Dec 2020. The outcome for the events, shaking, chills, headache, body aches, and sore arm, were not reported.; Reporter's Comments: This case concerns a 70-year-old female who experienced nonserious events of unexpected tremor and pain and expected injection site pain, fever, chills, headache. Event onset occurred the same day as the first dose of mRNA-1273. Treated with acetaminophen. Fever resolved, but other outcomes unknown. 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.
Severe urticarial rash, fever, fussy.  Follow up: Right thigh had site reaction.
Pain and swelling in both wrists, pain in both ankles and also swelling in right ankle. Acceleration of Lyme symptoms, tachycardia, onset of panic attack and more.
Soreness at injection site. Joint aches and pains, slight headache. Chills.
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344665, 2018SA344687, 2018SA344695 and 2018SA344689. This case involves a 78 years old female patient in which 0.5 ml of FLUZONE HIGH DOSE was potentially out of range for 7 days between 32 Fahrenheit and 47 F and exposed to freezing temperature (lot number: UJ006AA, expiry date: 30-APR-2019) via unknown route in the left deltoid on 04-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Initial report received on 14 September 2009 from a health care professional. A 4 year old female patient with no reported past medical history developed a reaction 2 hours and 45 minutes after receiving FLUZONE SV 2009-2010 (lot number U3186AA) intramuscularly on 10 September 2009 at 3:15 PM . At 6:00 PM, the patient developed a 2 to 3 inch red, circular lump, hot to touch and some discomfort. No treatment was required. The patient recovered. No other information was provided.
Patient received Moderna booster dose from a Moderna vial that was punctured over 20 times.  Talked to the patient today and advice patient to monitor for any side effects.
Woke up ~30 hours after vaccine with lt sided facial swelling and numbness, also had a headache upon waking up and took Excedrin but the swelling and numbness persisted, was seen in my office ~6 hours later and the swelling had resolved but the numbness and tingling of lt side of face persist.
Patient received immunizations on 8/10/15. He first rec'd MCV4 and Tdap in (R) arm. He then rec'd HPV9 in (L) arm. Immediately, patient became pale, lightheaded and had brief fainting event. He hit (R) side of head when he fell to floor but recovered quickly. Diagnosed by me with vasovagal syncope related to immunizations/mild head trauma -> recovered fully, no serious sequelae.
Patient was given Moderna 0.25, was to receive Pediatric Pfizer 2nd dose. patient had extended monitoring time no acute distress noted during observation period.
Patient was administered undiluted vaccine, resulting in higher dosage than recommended. Mother reports concern that child was acting "funny" and less responsive after vaccine was given, but when family was called to report incident 3 hours later, he was feeling well and had no side effects.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 13-MAY-2015, the patients were vaccinated with oral, ROTATEQ (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On 13-MAY-2015, the patient experienced incorrect product storage as improperly stored doses of oral, ROTATEQ were administered to them. No adverse event. It was unknown if the patients sought medical attention. At the time of this report, the patients' status was unknown. Additional information has been requested.
72 year old gentleman who presented to the emergency room with shortness of breath, cough and fever which started 6/3/22 (1 day prior to admission); he also had a sore throat; his wife had similar symptoms and was admitted with covid earlier on 6/4/22; he denies chest pain; he went to urgent care where he tested positive for covid and ems was called he has had swelling of his legs; he is not on home oxygen  Patient admitted to hospital. Is currently receiving remdesivir 200 mg IV x1 dose followed 24 hours later by 100 mg IV q24h x4 days
Severe swelling airway, SOB. Began about 24 hours after vaccine administered. To ED; treated with IV Solumedrol, IV Benadryl, PO Prednisone, PO Benadryl. Recovered completely. Follow Up: Diagnosis in ER was anaphylaxis. Patient was seen in ER 48 hourss/p vaccine receipt. Pt has history of mild egg allergy, but has received flu vaccine x 3 without AE.
Experienced dizziness and blurry vision, was unable to operate vehicle to home post first dose. Same side effect of extreme dizziness occurred after second vaccination dose. Pharmacist on duty performed 30mins of monitoring post second dose.  Additionally, within two weeks post second dose- developed bilateral nerve pain along arms down to hands and numbness/tingling in fingers. To date I have unresolved neuropathic changes and loss of sensation in my fingers and hands. There have also been periodic small blood spots appearing in the fingertips or palm of hands measuring  1-3mm that resolve within a few hours. The nerve pain causes much discomfort during work or normal daily activities, such as during sleep. The loss of touch sensation makes small activities such as typing or picking up items difficult.  Often the pain comes acutely and sharply, equivalent to the feeling of sharp pins radiating down the arm and at finger points.
pt recvd pneumococcal vax 14DEC92; pt was subsequently hospitalized w/dizziness, elevated BP & irregular heart beat; addtl details have been requested;
Debilitating shoulder pain in my left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Debilitating shoulder pain in my left shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ARTHRALGIA (Debilitating shoulder pain in my left shoulder). At the time of the report, ARTHRALGIA (Debilitating shoulder pain in my left shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Patient received DTaP, IPV, MMR on 11/1/02. On evening of 11/4/02 rash began on on face and spread. Pruntic, erythmacular papular rash on face, chest and back, both elbow and thigh. Zyrtec 1/2 tsp every evening.
sore arm; myalgia on side of the leg and foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MYALGIA (myalgia on side of the leg and foot) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (myalgia on side of the leg and foot). At the time of the report, PAIN IN EXTREMITY (sore arm) and MYALGIA (myalgia on side of the leg and foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-073913, MOD-2021-073689, MOD-2021-073650 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-073913:Son case MOD-2021-073689:Wife case MOD-2021-073650:Daughther case
fever, chills, bodyaches, fatigue and nausea. Took tylenol for pain relief; appetite poor d/t nausea, but able to tolerate liquids.
Joint Pain (day after, then again on days 6&7), injection site swelling (day 9)
Pt had a fever > 100, rash at site of injection and also a knot on the bicep at site of injection
Blood pressure high, ache joints and muscle bones, blood anemia, depression, arthritis, blood count strange numbers, digestive gastric ulcer, diplopia, double vision, hearing ringing in ears, poor tolerance for loud noises, infection fungal, pain rib cage, pain feet, like electrical shock, pain knees and hips, pain back, numbness and tingling in arms.
Patient received their 2nd dose of the Moderna vaccine, and the next day had a non-irritating rash on her trunk area. The rash was still present the next week when the patient received their Entyvio infusion, and following that infusion the rash became worse. The rash spread over most of the body, extending out to the arms and legs. The rash became bothersome, itchy, and warm. The rash did not respond to oral steroid treatment or anti-histamines. At this time, the patient still currently has the rash and is waiting on additional treatment from PCP.
Joints sore; joint popping; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer (patient) reported.  A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 6199), via an unspecified route of administration, administered in Left arm on 07Mar2021 11:15 (at the age of 39-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included sinusitis from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing known allergies. The patient concomitant medications included fluticasone propionate (XHANCE) once a day taken for an unspecified indication, start and stop date were not reported. The patient previously received Fluoroquinolones (FLUOROQUINOLONES) and experienced severe adverse reaction. The patient had not taken any other vaccine in four weeks. The patient was not diagnosed with covid-19, prior vaccination. Since the vaccination, the patient has not been tested for covid-19. On 07Mar2021 at 12:15 pm, within 1 hour after vaccination, the patient experienced Joints sore and popping starting right after the vaccine. The events continued and had been five days. The patient received for events were unknown. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
8x8 cm area erythema, central area firm & red. Pt reports generalized hives 1-23-11 - Took BENADRYL was given Rx ALLEGRA 180 mg today.
Patient was found to be dizzy, reported blurred vision, and vomited on the floor. This was after vaccine was given, approximately 5 mins prior, in the afternoon.
Pt presented to her PCP on 8/10/21. She reports  having "weird symptoms" right around the time of her 1st COVID vaccine on 7/18/21. Pt reports strangle heart sensations/palpations, feels like it is skipping a beat and she feels a "swoosh to the head", happening a several time an hour. Pt also experiencing incredible fatigue, feels like she could sleep around the clock, as well as bruising easily and not healing as fast as she normally would. She states that the fatigue feels like when she had mono. Denies any joint pain. Labs drawn that day indicate reactivation of mono
Received COVID vaccine on 5/17/21 5/25/21 around 0100 patient collapsed with acute onset right sided weakness and expressive aphasia. Brought to an ED where CTA found an occlusion of the L MCA which was confirmed as a ischemic stroke. He received TPA and underwent a IR guided thrombectomy. Patient continues to be admitted to the PICU with intermittent expressive aphasia and mild right sided weakness.
Patient came to RPh to let him know that she had a reaction to flu shot.  Her arm was red and itched.  She felt it was warm as well.  She was given Benadryl cream to apply to it and it went away in less that 24 hours.
About 10 or 11 hours, post vax, pt experienced joint swelling and stiffness in her legs and lower back. She was able to sleep but was awakened about 2 hours later with sharp, shooting pains in her hips and knees and had a fever of 102F. The pain caused nausea and emesis and a sensation of "couldn't sit still". Later she was able to take some Tylenol and slept but this AM her joints are still achy, swollen and tender. She is not able to return to work.
Left arm pain, warm to deltoid area, about 1mm red mark, red rash to face, nausea and joint pain.
This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, intramuscular, batch number: 204A21A, and expiry: 11-JUN-2021) .5 ml, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced expired vaccine used. On 12-JUN-2021, the subject experienced incorrect product storage. The outcome of the expired vaccine used and incorrect product storage was not reported. This report was non-serious.
intermittent nose bleeds / 3 weeks after had nose bleed and difficulty getting to stop / 5 weeks after couldn't stop bleeding after an hour; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 10Feb2021 (at the age of 65 years old) (Lot Number: EL9262) as dose 2, single for COVID-19 immunisation. Medical history included immunosuppressed after kidney transplant, high blood pressure, and high cholesterol. The patient was not pregnant at the time of the events. Concomitant medications included tacrolimus, mycophenolic acid, sulfa, and pantoprazole. Patient's allergies to medications, food, or other product included Ultram, IV iron, and CT contrast dye. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Tacrolimus, mycophenolic acid, sulfa, and pantoprazole were received within 2 weeks of vaccination.  The patient did not have COVID-19 prior to vaccination and had not been tested for COVID-19 post-vaccination. The patient previously took the first dose of BNT162B2 (Lot Number: EJ1686) administered in the left arm on 21Jan2021 at 08:00 AM for COVID-19 immunisation. On 24Feb2021, the patient experienced intermittent nose bleeds starting about two weeks after 2nd dose. About 3 weeks after 2nd dose, I had a nosebleed that I had great difficulty getting to stop. about 5 weeks after 2nd dose, I couldn't stop the bleeding after an hour. Event was treated with plug inserted in nose to stop bleeding. Event resulted in emergency room/department or urgent care visit. The outcome of the event was unknown.   No follow up attempts are needed. No further information is expected.
Very Bad Chills; She is Shaking Right Now; Her Chest Hurt; Jaw Hurt; arm pain; This is a spontaneous report from a contactable consumer (patient mother).  A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On 24May2021, the patient was experiencing the very bad chills right now and her chest hurt, and her jaw also hurts. The patient received ibuprofen (MOTRIN) at 800 mg for the arm pain (noted in 2021). Outcome of the event of arm pain was unknown while not recovered on the remaining events.  Information regarding the lot/batch has been requested.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: covid arm-Medium, Additional Details: COVID-ARM.
The patient did not complain of any adverse events. I am filing this because when I billed his second pfizer dose with his insurance I discovered that he also had 2 Moderna doses on 5/13/21 and 6/10/21. The patient never disclosed the administration of the first series and I was unable to reach him to discuss it.
HIGH BLOOD PRESSURE; LOW HEMOGLOBIN; SHORTNESS OF BREATH/  COULDN'T WALK 25 FEET WITHOUT BEING OUT OF BREATH; SNIFFLE; POST NASAL DRIP; CRAMPING IN LEGS; RED BLOOD CELL COUNT IS ONLY 3; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included ckd ( chronic kidney disease ), and heart issues. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered in left deltoid on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, Laboratory data included: Hemoglobin (NR: not provided) 9.3. On an unspecified date, the patient experienced high blood pressure, low hemoglobin, shortness of breath/ couldn't walk 25 feet without being out of breath, sniffle, post nasal drip, cramping in legs, and red blood cell count is only 3. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 180/85 mmHg, over 200, 155- 145, 150/80 mmHg, Haemoglobin (NR: not provided) 11.3, and Red blood cell count (NR: not provided) 3. Treatment medications (dates unspecified) included: hydralazine, and epoetin alfa. It was reported that 3 days later from the vaccination, he started experiencing dizziness. He also experienced headache that is still there. The patient further reported that dizziness comes and goes, it was constant before, but now it suddenly shows up and was not linked to his meals or standing up or sitting down. The patient did not found a link between his dizziness and activities.  The action taken with  COVID-19 VACCINE AD26.COV2.S was not applicable. The reporter assessed the causality between Janssen COVID-19 VACCINE AD26.COV2.S suspension for injection and cramping in legs as not related,. The patient recovered from sniffle, post nasal drip, and cramping in legs, had not recovered from high blood pressure, low hemoglobin, and shortness of breath/ couldn't walk 25 feet without being out of breath, and the outcome of red blood cell count is only 3 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210343260 -covid-19 vaccine ad26.cov2.s- high blood pressure, low hemoglobin. 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: UNDERLYING DISEASE
Headache-1 day Swollen and EXTREMELY TENDER lymph nodes in my left armpit-3+ days
Injection was administered it directly below my acromion process approximately 1.5 inches above the deltoid IM site. There is a small hematoma at the site of injection which was not into a muscle.
No adverse event; I administered two doses of Moderna Primary vaccine that were expired; Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Seizure. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Hyperlipidemia, Hypertension, Hypothyroidism and Type 2 diabetes mellitus.    On 27-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023).    No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714383 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2023: Live Follow up received contains non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714383:Same reporter
PATIENT STATES SHE HAS A RED ARM THAT EXTENDS INTO HER SHOULDER BLADE AND DOWN TO HER ELBOW.  SHE FEELS AS THOUGH HER LYMPH NODES ARE SWOLLEN IN HER ARM AND NECK AND SHE FEELS FLUID FILLED PATCHES (CYSTS) DOWN BY HER ELBOWS.  I ADVISED HER TO CONTACT HER DR.
Pt had received two Moderna vaccines and I gave the pt Pfizer vaccine as a booster.  Pt did not have any adverse events at the time.