chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 100.4, body aches, muscle aches, chills for 2 1/2 hours, dizziness, ringing in the ears, swelling of the throat difficult to swallow water, chest tightness, unable to take a deep breath, elevated BP at times with elevated heart rate resting 103 and in the event of BP 160?s/90?s with 139 BPM. Episodes last for 20-30 min at a time come out of the blew.
Pt had pain at injection site on L arm that lasted > 4 months that limited her range of motion and interfered w/ her sleep.
Painful abdominal cramping and unexpected vaginal bleeding (cycle began) about 24 hours after the vaccination. More painful cycle than normal continued to occur each subsequent month for 4 months.
Suspected vaccination failure; shingles; Rash; Hurting; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. The patient was treated with acetic acid (White Vinegar). On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. Couple of months after receiving Shingles vaccine, the patient got shingles. The reporter stated that spray rash with white vinegar and it really did make it stopped hurting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
This spontaneous report was received from a 72 year old female consumer concerning on herself. Medical history and concurrent conditions were not provided. Approximately in 2015 (reported as about 2.5 years ago), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot# and the expiration date were not reported) for prevention of shingles. Concomitant therapies included two unspecified inhalers budesonide, formoterol fumarate (SYMBICORT) and umeclidinium bromide (INCRUSE ELLIPTA). On 20-JUN-2017, the patient experienced shingles (herpes zoster) for an unspecified reason, had an outpatient visit to the Community Medical Center and received acetaminophen, oxycodone hydrochloride (PERCOCET) and gabapentin (NEURONTIN) as treatments for the event. At the time of reporting, the outcome of herpes zoster was reported as not recovered. The relatedness between the therapy with ZOSTAVAX and the event was not reported.
Received the flu shot on - 10/24/16 - a few days after the shot, the muscles in the left chest wall ache and muscles in left top back of arm and shoulder/shoulder blade area ache and burn. Pain has not subsided.
Patient reported a 1/2 dollar size, approx. 1 inch diameter size red spot at the injection site. Told mom to monitor the red area and seek medical attention if the redness continues to spread. Reported to Pharmacist at 6:40pm on 10/5.
Visibly and palpable enlargement of the left supraclavicular lymph node (Virchow's node), accompanied with pain; Neck pain on posterior and left lateral aspect; Lethargy; Mild soreness of the left arm at the site of vaccination; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration in left arm, on 16May2021 at 10:00 AM (at the age of 33 years), as second dose, single dose, for COVID-19 immunization. The patient's medical history included attention deficit hyperactivity disorder (ADHD). There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: ER8736) on 25Apr2021 at 12:00 PM (at the age of 33 years) for COVID-19 immunization (left arm). The patient had no known drug allergies (NKDA). The patient was not diagnosed with COVID-19 prior vaccination. The most recent vaccine was administered in a pharmacy or drug store facility. Two days after the second dose (as reported) (administered on 16May2021), the patient noted a visibly and palpable enlargement of the left supraclavicular lymph node (Virchow's node), accompanied with pain, locally and neck pain on posterior and left lateral aspect starting on 17May2021. Other symptoms past the 24 hours of second dose administration (17May2021) were lethargy that lasted 2 days and mild soreness of the left arm at the site of vaccination. It was unknown if treatment was given for the events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from "Lethargy" on 19May2021. The patient had not recovered from the other events.
lmpropely stored vaccine administered; route: IM; This spontaneous report was received from a licensed practical nurse referring to a 13 month old (reported as 14 months old) male patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 03-AUG-2021, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not reported, dose number: 1 (reported as previous doses number was 0), lot # T002847, expiration date was reported as 23-JAN-2023, upon internal validation established as 23-JAN-2022) intramuscularly in the left thigh for prophylaxis (product storage error and incorrect route of product administration). The digital data logger was involved to capture the temperature excursion.       This is one of several report reported by the same reporter.; Sender's Comments:  US-009507513-2108USA006311:
Day after vaccine L arm red, swollen, and itchy at the injection site and mild achiness.  Third day post vaccine I had hives.  Took benedryl as had been recommended through out the day.
Patient was in excellent shape prior to deployment (no complaints, no medications, running a first class physical fitness test).  Patient was preparing to deploy for three months.  Patient received six vaccinations during deployment (30 Nov - PPD; 03 Dec 2004 - Yellow Fever and Smallpox (15 jabs);  14 Dec 2004- Flu and Typhoid; 16 Dec 2004- Meningococal).  On 30 December, patient began to develop neurological symptoms which were eventually diagnosed upon patient's return home as Amyotrophic Lateral Sclerosis (ALS- Lou Gehrig's Disease) on March 15, 2005.
A few minutes after the shot, I started to see "Floaters" in the field of vision of my sight. The amount /density of floaters is analogous to medium rain fall. After about an hour, kit kind of went away except for my left eye. I see a couple good size black "Floaters", and has stay that way since.
Redness and swelling at injection site. Flushing of skin and itching of skin within 20 min. of injection. Took BENADRYL and subsided RXN.
Tightness in chest, shortness of breath throughout my day. When I exercise I become fatigued (sweaty and breathing heavier than normal) from the same exercise that I have done prior to vaccine.
I was 3 weeks pregnant at the time of the 2nd moderna shot. Due date was set for 1/9/22. Discovered I was miscarrying at 15 weeks (7/16/21). Contact from the V-safe program reached out and suggested I submit a report.
Swelling of blood vessels/neck/Blood vessels are like sticking up to blow up the veins; Swelling of her arms, legs, feet and hands; Pain all over her body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling of blood vessels/neck/blood vessels are like sticking up to blow up the veins, swelling of her arms, legs, feet and hands, pain all over her body. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shot #1:  Pain at injection site for 3 days.  Itching from top of head to bottom of feet (entire body) for 6 hours.  Brief sharp pain in right chest only once.  Major fatigue for 10 days.    Shot #2:  Pain at injection site for 3 days.  Body aches for 7 days.  Fever with chills and sweating for 5 days.  Nausea and lack of appetite off/on for 7 days.  Severe headache with electrical storm throughout head for 5 days.  Tried Tylenol 1,000mg TID which barely dulled the pain.  Oxycodone 5mg (left over prescription) did not help (tried twice).  Major fatigue for 14 days followed by tapering of fatigue over next 13 days (today).
Fever of 101.4 for 3 days with chills severe headaches, muscle aches and pressure in sinus area and ears with severe tinnitus that has never resolved since first vaccination for 2 weeks went to urgent care and was diagnosed with bilateral ear infections and sinus infection prescribed Flonase and doxycycline for 10 days.
Patient has a history of reactions and had a 30 minute wait in the waiting room. Patient started feeling 'itchy' 5 minutes after her vaccine. Administered 10ml of benadryl and assessed patient. After 5 minutes administered 10 ml more of benadyl. Assessed patient, after 5 minutes of itching Patient continued to get worse. Administered 20ml more of benadryl. No signs of hives, difficulty breathing or tightness in her chest. Patient stated that this was normal and she felt comfortable with going home. Released from wait room at 4:30pm
Developed rash in neck area the day after the vaccine. Also his tics from Tourette Syndrome worsened so much that he has an appt. with dr tommorrow to do blood work etc.
Round circle 3 inches in diameter at vaccine site.  "Beet red"; hard and hot; no fever in child as described by mother of child.
administered vaccine to patient which vial was unpunctured 2 weeks ago; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine to patient which vial was unpunctured 2 weeks ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine to patient which vial was unpunctured 2 weeks ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine to patient which vial was unpunctured 2 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD21-079129, US-MODERNATX, INC.-MOD-2021-081595 (E2B Linked Report).; Sender's Comments: This report refers to a case of Expired product administered (administered vaccine to patient which vial was unpunctured 2 weeks ago) for mRNA-1273, lot # unknown is assessed as not applicable. MOD21-079129:Crosslinked US-MODERNATX, INC.-MOD-2021-081595:Crosslinked
Left shoulder discomfort that initially began at time of injection at the injection site.  The pain persisted at the injection site and then radiated anteriorly and posterior to the  injection.  The pain can reach up to level 8 upon certain arm movement, and has affected my quality of life over the past 3 months.
Significant swelling, redness and pain at injection site that lasted for at least a week. Headache, muscle aches, fever, general malaise that were severe for about 36 hours. Fever subsided after 36 hours, but milder symptoms persisted for 2 more days.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/25/21 and 3/1/2021. Covid + 1/25/22, Presented to ED 1/25/22 c/o SOB and fatigue. Placed on BIPAP in ED due to worsening hypoxia. Admitted for acute hypoxic and hypercapnic respiratory failure complicated by pneumonia. Treated with remdesivir, Decadron, cefepime. Patient SOB continue to worsened, and family changed status to DNR/Comfort care. Expired on 1/27/22.
Local reaction to COVID vaccine.  11 cm length x 14 cm width circular "bulls eye" circular area to left upper arm, warm, red, raised, non tender, pt reports some/minor itching.  TX:  hydro-cortisone cream 1% BID x 1 week, benadryl 25mg PRN itching - no scratching, F/U if no improvement.
Severe muscle spasms, stiffness and heavy feeling; Severe muscle spasms, stiffness and heavy feeling; Severe muscle spasms, stiffness and heavy feeling; This is a spontaneous report from a contactable nurse, the patient. A non-pregnant 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1111111) via an unspecified route of administration on an unknown date at the age of 50 years as a single dose for COVID-19 immunisation. Medical history included hypertension, eggs allergy and milk allergy. The patient previously took Phenergan and experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was not reported that if the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date, the patient experienced severe muscle spasms, stiffness and heavy feeling in episodes lasting 30 seconds to 2 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle spasms, stiffness and heavy feeling was not recovered at the time of this report.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (24May2021): This case is being submitted to notify that the initial information for this case was first received by the Company on [24May2021] and not on [25May2021] as previously reported. And below amendment has been done together: To amend 1, PRD correction. 2, Postal Code added in Patient Tab. 3, Age/ Age at Vaccination added. 4, Suspect product's lot No. removed from the Products Tab but retained in the narrative. 5, AE "Severe muscle spasms, stiffness and heavy feeling" was split and re-coded to "muscle spasms", "muscle stiffness" and "myalgia". 6, Final sentence updated from "No follow-up attempts are needed. No further information is expected." to "This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.". 7, Narrative updated accordingly.
Left arm pain at site of injection of flu shot began 3 days after injection and has continued to date. Some relief with Ibuprofen. Pain radiating up and down Left arm to shoulder, elbow, armpit, left chest.
DRY HEAVES; COUGH; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the subject experienced dry heaves. On 11-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry heaves, and cough. This report was non-serious.
Case previously recorded as MA2009-3331. Initial case report received from a physician via MedCom on 26 OCT 2009. A 23-month-old child was vaccinated with 0.5 ml S-OIV FLUVIRIN (batch no 100813-7P) i.m. on 24 OCT 2009. No adverse event was reported. Reference no. NA09-07008.
Flu vaccine administered 11/15/05 9:30 am. About 2-3 hours later states she started feeling hot/itchy with facial and chest flushing. Also scratchy throat. First time ever to receive a flu vaccine. Took Benadryl 3 times. Symptoms have decreased. Now only has redness on one facial cheek. No itching. Telephone call to employee to evaluate symptoms States she has greatly improved. No further itching and redness decreased to one side of face only. Resolving facial redness and itchiness post flu vaccine. To notify her PMD and update EHM if symptoms return. Employee reported to EHM that she had developed "facial and chest redness" and a "feeling itchy about 2-3 hours after receiving a flu vaccine on 11/15/2005 around 9:30 am here at the main clinic. Went home and took 2 Benadryl which started to relieve s/s and a third Benadryl before bedtime. Continue to have facial flushing and achy feeling today, so came to EHM for evaluation. Hoc Anaphylaxis to medications. Known allergies to cortisone, morphine and penicillin. Hx of essential tremor treated with Inderal. OTC meds included vitamin C and multivitamin. Facial and chest redness remains present BP 122/72, pulse 60, lungs clear. Possible reaction to flu vaccine. Benadryl 25mg tax times 1 given now and one dose for later in the day. After returned to regular work. Vaers form completed. Will reassess on 11/17/05. Instructed if s/s worsen to notify her MD. Recommended no future flu shots Verbalized understanding.
Approximately one week after getting the second dose of the Moderna Covid 19 vaccine I started experiencing pain in my left outer ear.  The cartliage feels sore and painful.  I do not have congestion in the ear or any loss of hearing.  The pain is only on the left ear on the outside.  At first I chalked it up to seasonal allergies but I have NEVER had this with allergies or colds.  It comes and goes since the vaccination.  I have the pain several times a week.  I cannot correlate it with sleeping on that side, talking on a phone or anything else.  I haven't had trauma to the area or anything.  I have recently researched this symptom to see if there have been symptoms like this reported after the vaccine and I have seen a small number of cases reported.  I  felt it was worth reporting as this could possibly be a side effect to the vaccination.  I'm going to a doctor in the next couple of days to make sure there is nothing going on inside the ear to cause the pain on the outside. I have read that reporting anything that may be a side effect is encouraged.
On June 10th, I woke up coughing really hard; very fatigued and slight fever. The days prior was that my chest hurt at all times - pain in my chest. On the 10th,  Telehealth visit and call-ine nurse ordered tests. I got COVID tested and chest x-ray and both were negative.  OTC - pain reliever and fever reducer. The chest pain leading up to the coughing started June 6th. All the symptoms probably lasted until the 15th of June.
Within 2 hours of the vaccine  (2nd shot Moderna)- i started bleeding , not a lot but enough to stain my underwear, there was no bleeding the next day, but the next day - (48hours after shot) i was bleeding again - moderate bleeding, soaked thru underwear.  but did not continue after that time.   Summary - bleeding within 2 hours of shot, and no bleeding until 48 hours later, not a lot of bleeding but enough to scare me.  I am 74 years old, had not had my period for over 20 years I had no side effects after the first shot, except sore arm, and no side effects except for the bleeding and sore arm after 2nd shot.
Tdap given 4/18/07. Three days later had pain from elbow to shoulder with lump on left deltoid. Has had PT last month - still having pain and cannot raise shoulder completely. No edema or redness noted.
Moderna COVID-19 Vaccine EUA  Injection site pain; constant significant exhaustion; significant joint pain, "flu like symptoms"
Bad muscle and joint pain. All over. Lasting 36-38 hours.  Feeling cold, freezing, shaking. Last about 30 hours.  At injection site-very painful, red, hot to touch, knot larger than a 50 cent piece. Still present but less pain and not so hot to touch.
Hives/itching/swollen lymph nodes/high WBC count. Primary care put me on Claritin and hydroxyine. Went to urgent care 2 days later, hives were worse. Got sent to ER because of WBC count. ER DR gave IV steroids & Pepcid. Put on 12 day course of steroids, plus two different allergy pills a day. Saw allergist a few weeks later. Hives went away completely begging of April but still taking one allergy pill still.
No additional AE; MA reported that one Patients ( name or initials not provided when asked) received  ROTATEQ ( lot number U038854 exp: 04/20/2023) exposed to 55 F for 15 min. Temperature excursion happened on  Sept 7,2022 and patient received it on 11/18/2022.; This spontaneous report was received from a Medical Assistant regarding a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-SEP-2022, an improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion of 55 degrees Fahrenheit (F) for 15 minutes.  On 18-NOV-2022, the patient was vaccinated with the improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U038854, expiration date: 20-APR-2023, taken orally as prophylaxis (strength was not provided) (Product storage error). No adverse events were reported.  This is one of two case received from the same reported.; Sender's Comments:  US-009507513-2212USA005869:
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Patient did not list an allergy.  Concurrent medical conditions included Immunocompromised.    On 20-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (Dose administered after 30-day Use By Date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dosage text was reported as Initial Booster.  No treatment medications was reported.