chrisvoncsefalvay/vaers-outcomes huggingface dataset:
By 8:00 PM on the date of the injection her arm around the injection site was swollen and warm. She came into the office the next morning at 10:00 AM and the redness and swelling had migrated down towards the elbow and was tender. See attached office note from 11/20/2007.
Initial and follow up information has been received from a health professional concerning a 70 year old retired white male patient who no reported previous vaccination history and a history of diabetes and weight loss, who on 11/29/04 at 10:49 AM was vaccinated IM in the left deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). No concomitant medications were reported. On 11/30/04 the patient returned to the office with a severe adverse reaction to the pneumococcal 23v polysaccharide vaccine. It was reported that his left arm was very swollen, very red and he had a bad headache. It was also reported that he was only able to sleep 1-2 hours at a time the same night as the vaccination because of the pain. The doctor recommended the patient take famotidine 2 BID, fexofenadine hydrochloride 180mg every day, and acetaminophen (+) hydrocodone bitartrate 5, 1 every 4 hours or 2 every 6 hours, as needed for pain. It was also reported that the patient had no illness at the time of vaccination and that the patient lost weight and is no longer diabetic. The patient recovered approximately 3 weeks later on an unspecified date. The physician considered the patient's experience to be an other important medical event (OMIC). No product quality complaint was involved. Additional information is not expected.
No additional adverse event reported.; Nurse gave expired PROQUAD to patient, expired on 19-JAN-2021; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drug and concomitant therapies was not provided.  On 20-JAN-2021, the patient was vaccinated with one dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number F022916 Expiration date 19-JAN-2021 (dosage regimen and route of administration were not provided) for prophylaxis.  Lot number F022916 is invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Lot number F022916 does not match any company product as confirmed by lot verification team.
He got his vaccine, at first a couple of hours later he had swelling on Sunday morning.  Then about a day later he noticed that the swelling was still there on Monday, and had red spots on the arm.  When he came home Monday night it looked like the red spots got bigger like they were going to pop and something else was going to happen.  On Tuesday morning he has a really bad burning sensation in it, and also blisters that popped at the injection site only.  It likes a big circle, he can see where the injection was given, and it's probably about 3" wide around it.  It is hot to touch, very painful, it burns, and does not know what to do or put on it.  He has an appointment with his old doctors associate on Friday.  He has not seen anybody for this yet.   He called the pharmacy when he got his vaccine and they told him to call us.  He noticed that yesterday that the blisters popped, there is about 25 of them.  It's like a bunch of little dots all around the area.
This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: ER 2613) via an unspecified route of administration on the left arm on 19Mar2021 at 02:00 PM (at the age of 23-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history and concomitant medication were not reported. On 21Mar2021 at 20:00, the patient experienced rash, irritating and red spot. No therapeutic measures were taken as result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of rash, irritating and red spots were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Numbness in whole hand and fingers; tingling in finger; Pain in neck; neck stiffness/neck spasm; flushing; feeling hot; itchy eyes; Rashness and thicknening of the skin; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in whole hand and fingers), PARAESTHESIA (tingling in finger), NECK PAIN (Pain in neck), MUSCULOSKELETAL STIFFNESS (neck stiffness/neck spasm) and FLUSHING (flushing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B2117 and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient allergic to quinines.).   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in whole hand and fingers), PARAESTHESIA (tingling in finger), NECK PAIN (Pain in neck), MUSCULOSKELETAL STIFFNESS (neck stiffness/neck spasm), FLUSHING (flushing), FEELING HOT (feeling hot), EYE PRURITUS (itchy eyes), RASH (Rashness and thicknening of the skin) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in whole hand and fingers), PARAESTHESIA (tingling in finger), NECK PAIN (Pain in neck), FLUSHING (flushing), FEELING HOT (feeling hot), EYE PRURITUS (itchy eyes), RASH (Rashness and thicknening of the skin) and CHILLS (chills) outcome was unknown and MUSCULOSKELETAL STIFFNESS (neck stiffness/neck spasm) had not resolved.            No concomitant medications were provided by the reporter.  It was reported that after 2 and half to 3 months later (may-2021) patient started noticing numbeness of right hand, twingling of fingers and stiffness of neck especially while sleeping, un esay when hand is in rest, unable to see the mirror.  This case was linked to MOD-2021-241131 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Added patient height & weight,,batch/ lot number of the first dose, allergic condition, updated the vaccine facility information, treatment for neck spasm,updated symptoms include chills, flushing, feeling hot, rash & the event out come for neck spasm as ongoing.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Additional Details: Quick numbness in hands that resolved immediately.  Lightheadedness and nausea started about 5 minutes after injection and lasted about 30 minutes.
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Supraventricular tachycardia (pt has prior hx of this): ambulance to hospital. Pt assessed & released same day. Pt is free from that symptom now. Also experienced painful knot under arm lasting 5 days
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/14/2021 HYPOXIA R09.02 HYPOXIA 9/14/2021 HYPOXIA
Customer was given her second dose of Shingrix. 2-3 minutes afterwards she felt overly dizzy, and about to loose consciousness. Her husband helped her to the ground, I rushed out for assistance. She did not loose consciousness but felt tingly and nauseous. 911 was called. kept feet elevated, monitored breathing and heart rate untill paramedics arrived and took over. Patient got better shortly after and did not leave to hospital.
This spontaneous report was received from a medical assistant referring to a 24 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-APR-2018, the patient inadvertently received one pediatric dose of VAQTA Intramuscularly (dose, lot and expiry date not reported) (Drug administered to patient of inappropriate age). No adverse effect reported.
Very severe pain in left shoulder where vaccine was given and unable to move left arm any direction without extreme pain. Temperature of 100 for 24 hours. Redness and swelling of left shoulder in the area of the vaccine. 48 hours later still very painful but have mobiity in my left arm.
Inflammation, fever, tachycardia, redness, pain. On the shoulder, prevention of  arm mobility.
Patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported.  Total 190 patients had received the vaccine.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case pertains to the 35th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 11-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
DEATH; This spontaneous report received from a consumer concerned two patients unspecified age and sex. This report received via social media.. 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 administration not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total 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. It was reported that two people died recently after the vaccine. The cause of death was unknown. It was unspecified if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Delayed symptoms by 12 hrs after vaccine, body aches with on and off mild headaches for 24 hrs not affected by ibuprofen use.
Sporadic pustules started on back of right thigh moves to various areas. Left thigh, buttocks, belly, back, right arm.
LOW GRADE FEVER; TIREDNESS; BODY ACHE; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included patient had no known allergies. patient had no use of drug and drug illicit usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, treatment medications included: ibuprofen. On 24-MAY-2021, the subject experienced body ache. On 24-MAY-2021, the subject experienced tiredness. On 25-MAY-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on 25-MAY-2021, had not recovered from body ache, and the outcome of tiredness was not reported. This report was non-serious.
She got the vaccine, and where she got the shot it turned red, about the size of two silver dollars, very sore.  Right above that a very big red spot popped up.  She had itching and bumps on her feet and then over her whole body.  she had red spots and a rash on her stomach, and a big rash on her back and all over her face. She had diarrhea, headache, flu symptoms with aches all over her body.  The aches went away except in her feet and her toes, it hurt to walk due to the toe pain.  She still has the bumps and the itching, but took the Benadryl, but cannot take that as it gives her restless leg syndrome, and is now takin Claritin.  She now has itching in her lips, has allergies in her eyes,   She has not call her doctor.  She talked to the person who gave her the shot and also Wal-Mart pharmacist who told her to take the Claritin.  These symptoms have continued.
Lightheadedness, dizzy, heart palpitations. It was a bit intense for a few hours.
no adverse effect; M-M-R II administered to a patient intramuscularly; This spontaneous report as received from a pharmacy intern/healthcare student refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent(STERILE DILUENT)  On 22-MAY-2019 the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (0.5 ml) (lot # R029513, expiry date: 14-OCT-2020) intramuscularly for prophylaxis (incorrect route of product administration). No adverse effect was reported. No product quality complaint was involved.
3/25 - soreness at injection site.  3/29 - Extreme fatigue, body aches.  3/30 - Fatigue, body aches, headache, sudden loss of hearing and tinnitus in right ear, diziness with vomiting.  3/31 - Family physician recommended taking Zyrtec for tinnitus, still having fatigue but seemed to be improving, bad headache returned.  4/1 - Able to hear just a little in the right ear after 2 doses of Zyrtec but tinnitus and loud ringing in the ear this morning with headache.  Fatigue seems a little better this morning.
Swelling and pain at the injection site and felt warm to touch for two days; aching in every joint in my body for two days, felt feverish and had chills, malaise
joint pain in left shoulder, no local redness or swelling, pain limiting ability to lift left shoulder above head
With all the other vaccines they did got a headache and soreness in the left arm.; With all the other vaccines they did got a headache and soreness in the left arm. This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     Patient did not have any allergies. Patient never had positive COVID-19 test and diagnosis.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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 PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.). At the time of the report, PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-586334, MOD-2022-586329, MOD-2022-586322 (Patient Link).
Patient received vaccine as part of on campus clinic. Shortly after he received the vaccine, he had seizure like activity. Upper extremity muscles contracted. Distant gaze. Did not lose consciousness. Resolved quickly - was A and O x3, and then had diaphoresis, pallor, and lightheadedness. These sx resolved quickly as well without treatment. Once patient seemed back to baseline patient taken to campus health center for evaluation.
ITP with platelet count of 2K.  Presented with subdural hematoma.  Platelets recovered with dexamethasone 40mg PO daily and IVIG 400mg/m2 daily x 4 days.  No further brain bleed.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up
Anaphylactic reaction to a trivalent influenza vaccine; This spontaneous case received on 05-Apr-2021 from a physician via Med Communications (reference number: SEQW21-01125) and concerned a female patient of an unspecified age.  The patient's medical history and concomitant medications were not reported.  On 24-Sep-2009, the patient was vaccinated with trivalent influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 96033.  On an unspecified date, an unknown amount of time after receiving trivalent influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to the vaccine.  The outcome of the event was not reported.  The reporter assessed the event as related to trivalent influenza virus vaccine polyvalent.  The event of 'anaphylactic reaction to vaccine' was considered to be medically significant by a Physician within Risk Management Department.  The physician stated that the patient had not been under her care nor received the vaccine from her and therefore, no additional details would be provided.  Company comment: A female patient of an unspecified age was vaccinated with trivalent influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving trivalent influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to the vaccine. Causality is unassessable, due to unclear information regarding temporal relationship and diagnostic findings. Brighton Collaboration criteria could not be assessed due to insufficient information.; Reporter's Comments: The physician reported that had a patient who experienced an anaphylactic reaction to a trivalent influenza vaccine.; Sender's Comments: A female patient of an unspecified age was vaccinated with trivalent influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving trivalent influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to the vaccine. Causality is unassessable, due to unclear information regarding temporal relationship and diagnostic findings. Brighton Collaboration criteria could not be assessed due to insufficient information.
arm swollen & painful inj site x 3-4day;then pain in face-teeth hurt-had tooth pulled 10 day later;
48 hours of high fever; persistent fatigue and weakness after fever; awkward motor skills. Full bed rest, lots of fluids. Fever broke after 48 hours.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006064: