chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight pressure on the ear and jaw; slight pressure on the ear and jaw; very achy; exhausted; This spontaneous case was reported by a nurse and describes the occurrence of EAR DISCOMFORT (slight pressure on the ear and jaw), PAIN IN JAW (slight pressure on the ear and jaw), PAIN (very achy) and FATIGUE (exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced EAR DISCOMFORT (slight pressure on the ear and jaw), PAIN IN JAW (slight pressure on the ear and jaw), PAIN (very achy) and FATIGUE (exhausted). At the time of the report, EAR DISCOMFORT (slight pressure on the ear and jaw), PAIN IN JAW (slight pressure on the ear and jaw), PAIN (very achy) and FATIGUE (exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received booster on 11 Jan 2022 at 5.00.  Concomitant product use was not provided by the reporter.  No treatment information was provided.
pt c/o lt arm aching progressively worse, cannot really use its, states w/in 1hr of vax felt achy pain;no swelling;whole arm ached for 12hr p/vax;got better & then worse;will see MD 21NOV97;dx bursitis sub acromial;
Paralysis of lower extremities (legs) Impaired vision cognitive functions all part of an MS attack
Pt reports went to ER and treated for hives- was given benadryl 11/05/05
Pfizer-BioNTech COVID-19 Vaccine EUA.  2 mins after injection, passed out and seized in my car for approximately 30 seconds. 5 medics and the 2 injection techs assisted me. Blood pressure was incredibly low, but heart monitor and blood sugar came back fine. Declined going to the hospital. The following day woke up with hives all over my face, neck and ears that last about 6 days with continual use of Benadryl.
Vaccine that was administered on 11/19/2021 expired on 11/18/2021.
Hot, sweaty, nauseous and fatigued for a few hours, then chills for an hour or two. Rest of the day felt very fatigued, body felt like jello or bag of sand. Symptoms subsided on their own within 24 hours. Headache on day 2.
Patient felt faint, responded to fluids, snacks BP 100/60 P 72
6/21/2023 nurse approaches vaccine Coordinator and states, " I gave an expired HIB vaccination to this kid."  Vaccine Coordinator and nurse confirm it was given from the state supply.  Vaccine Coordinator informs nurse  that email will be sent to Community Health Nurse with health department informing of incident. Pts provider informed. 6/22/2023 email submitted.  Pt will be vaccinated a 2nd time with HIB vaccination at 15 month well child check.  Mother called and informed and voiced understanding.
c/o rt elbow pain; sharp - no edema or redness @ site, c/o feeling warm, noted blotchy redness of face; Very fine red rash on neck, shoulders, no itching or resp distress; VS stable; rash spread to upper chest given DPH;
Raised red indurated lesion about the size of a palm without ulceration. Warmth and erythema present. Lesion on right arm at triceps.
extreme soreness in muscles head to toe, especially neck, shoulder, arms, hands, legs. One night my neck locked up in pain and I couldn't move, called ambulance which took me to hospital where they put me on cyclobenzaprine muscle relaxer, prednisone and hydrocodon for pain.
Two days after shots developed diarrhea and wouldn't eat; 3rd day wouldn't walk, acted "like muscles hurt", 4th day kept Pedialyte down went to clinic & was told she had a GI upset, no signs of symptoms of dehydration & sent home. 5th day has diarrhea and vomiting, not taking solids. Called doctor again and was told to give Pedialyte- "start over' * call back tomorrow. 3/31/04. Still with Nausea & Vomiting.
Scab at injection site; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on an unknown date in 2021(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 02Mar2021 at 13:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not tested for COVID-19. On 23Apr2021, the patient experienced scab at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of scab at the injection site was not recovered at the time of report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Patient was given an adult dose of Moderna Covid Vaccine (100mcg) when he should have been given Moderna 6-11year Vaccine (50mcg)
3 days after receiving DTAP in left deltoid left arm from elbow to shoulder had large red welts that were hot and painful. BENADRYL 25 mg taken everyday QD until 5/8/14 and welts resolved 5/10/14.
Severe body pain/aches all over Fever that will not go below 100.7 with medication Severe headache Nausea Cognitive foggineds
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored dose of RECOMBIVAX HB lot number reported as M000442, expiration date on 31-MAR-2018 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Patient had generalized hives and extreme itching about 20 to 25 minutes after the immunization.  Her mother informed me about 1 hour after the shot to inform us of the incident. The patient had taken Benadryl and had an Epipen on hand in case of throat swelling, or increased heart rate, but had not had to use it. The patient did not go to a emergency department or urgent care, to her mother's distress.  I urged her if there were anymore anaphylaxis response, to seek medical attention.  The mother stated that due to her alpha gal allergy, she should not have taken the vaccination. I thank her mother for letting me know about the incident on  11/30/21 and if there are any devolpments, don't hesitate to call us again.  Upon trying to call patient upon completion of this VAERS, we have tried to call the patient to follow-up, but have not gotten a response.
L SHOULDER BLADE PAIN, RADIATING INTO L CHEST, UNRELIEVED BY ICE AND/OR HEAT
The child experienced crying, scratchy, and broken out. The pt is allergic to dairy products. The pt was sent to the PMD.
Around 630, I started getting a headache. My arm was sore. By 7, I was itchy all over, around 10, I started getting a tight feeling around my chest whish lasted several hours.
Infant was fussy many days prior, that evening was inconsolable. Late evening-early morning started vomiting and having bloody diarrhea. Went to ER, discharged with diagnosis of "virus" and instructions to give Pedialyte. Went to see pediatrician first thing 9-8-2005. Was sent to hospital to be "observed". Second attending physician, admitted my daughter and found she had an intussusception. Her bowel already died and she was sent in for emergency surgery. Complications surgery wound was infected had to reopen and surgical cut had to be kept open.
Shingles lasting 3 weeks. Chiropractic treatment, narcotic pain medication, anti itch medication.
red, itchy lesion on the injection site which progressed to become raised, very hard squarish; red, itchy lesion on the injection site which progressed to become raised, very hard squarish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) and VACCINATION SITE ERYTHEMA (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) and VACCINATION SITE ERYTHEMA (red, itchy lesion on the injection site which progressed to become raised, very hard squarish). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) and VACCINATION SITE ERYTHEMA (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) had resolved.            Concomitant medications were not provided.  Patient did not experience any adverse reaction after second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Event outcome and action taken updated.
VACCINE use for COVID-19 under Emergency Use Authorization (EUA): the patient had a fall the next day after receiving a EAU COVID-19 vaccine in November 2022. The fall was so severe that the pt ended up with a wound that required surgical debridement and vacuuming of fluid off and physical therapy and a walker for ambulation. He is now back ambulating with a can and only with a walker early in the morning. The patient still has some orthostatic hypotension likely due to other drugs DIGOXIN 125mcg 1 tab po qd, METOPROLOL TARTRATE 25mg ss tab po twice daily, and furosemide 20 mg 1 tab po qd. I do not have the details of the specific covid-19 vaccine. This information was gathered during a MTM conversation.
Patient received a ZOSTAVAX vaccine in the left upper arm and the next day noticed redness in the area that is warm to touch. Patient states that she does take ZYRTEC. Red area is "palm" size and itchy.
Information has been received from a physician concerning a 6 year old female with no pertinent medical history or allergies who in approximately 2004 (2 to 3 years ago) was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In approximately 2004 (2 to 3 years ago) the patient developed a rash on her trunk after receiving her first dose of varicella virus vaccine live (Oka/Merck). In approximately March 2007 (within the last six months) the patient received her 2nd dose of the vaccine. About one hour after receiving her second dose the patient's face and lips became red and swollen. Later that night her trunk also became red. The next day the patient had a hive on the opposite arm that the vaccine was administered. No diagnostic labs were performed. Unspecified medical attention was sought. The patient was treated with Benadryl and fully recovered from all adverse experiences. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of muscle soreness in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced muscle soreness, chills and tremor. On an unknown date, the outcome of the muscle soreness, chills and tremor were unknown. It was unknown if the reporter considered the muscle soreness, chills and tremor to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for herself. The age at vaccination was not reported. The healthcare professional reported that after receiving SHINGRIX, she developed sore muscles, shaking and chills. During this report, the healthcare professional stated two of her patients had similar symptoms after receiving SHINGRIX and would report those two separately from her adverse event. This case has been linked with case US2018154162 and US2018154163, reported by same reporter.
Nausea and vomitting, diarrhea, SOB, bodywide hives.
A serious, spontaneous case of anaphylactic reaction, throat tightness, swollen eyes, hives, wheezing and sneezing has been received from a nurse in an 11-year-old male. Drug and medical history indicated the child was in his sixth year of receiving a series of allergy shots for cat, dog, birch, maple, oak, ragweed, duct, mite and mold. The child has had mild reactions to the allergy shots in the past. It was reported the child had no allergy to eggs but is allergic to sulfa drugs. He has had frequent ear infections and has ADHD. The patient received FluMist intranasally as well as allergy shots at approximately the same time on 24-Oct-2007. The reporter indicated that twenty minutes after administration the child had an anaphylactic reaction including tightness of the throat, swollen eyes, hives, wheezing and sneezing. The child was administered epinephrine and Benadryl; 20 minutes after the treatment his oxygen saturation was 99% and heart rate 105, his chest was clear and the hives resolved. He was transported to the ER where he was observed and released later the same day. The reporter indicated the events resolved the same day. No further information is available on FluMist dosing. The reporter indicated the child's physician and his allergist both thought the reaction was due to FluMist. The reporting source of this case is spontaneous, thus the sponsor's thus the sponsor's comment is not applicable.
My symptoms began on Saturday, July 30, 2022. We had traveled to a couple different states. I had sneezing, runny nose, little bit of chest congestion and a loose cough. I tested negative on that day. Sunday I had laryngitis along with sneezing and runny nose. It felt like just a regular mild cold. Monday, Tuesday, and Wednesday it continued to be the same. I did a PCR test and results were positive on Tuesday. One of the days I had a substantial rattle in my chest and voluntarily coughed and coughed to clear it. I called my doctor on Tuesday to consult about PAXLOVID. We agreed that I should not take it due to the medications that I was already taking along with the fact that my symptoms were not severe. By last Thursday I felt normal again. I still have minor cough only to clear to my throat.
neutropenia after first dose; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient developed neutropenia after first dose on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported neutropenia cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt. returned today 4-25-16 for MMR #2 - She stated that after her last MMR her arm swelled to size of a "football" was red and painful. She went to her primary MD on 3/28/16 where he treated her w/Diphenhydramine and Ibuprofen and inst. her to ice it. RN noted that there is still a walnut sized lump at inj site. No other s/s.
Patient received an Ipol vaccine that was later noted to be expired, with no adverse event; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case from other health professional and physician.  This case involves a 10 years old female patient who received 0.5 ml  IPV (VERO) [IPOL] vaccine (lot R18251M and expiration date: 13-Mar-2021), that was later noted to be expired (expired product administered). Vaccine was given via intramuscular route in the left arm for prophylactic vaccination on 31-Mar-2021.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medications were given to the patient.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was not reported whether the patient had any adverse event.  Reporter reported that she would like to find out about next steps and if the patient would need to be re-vaccinated.  It was also reported that treatment will be repeated.   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.
Lightheaded at the immediate onset of injection but quickly dissipated within seconds. Also a shooting pain reaching the wrist during and after injection for about 30 minutes. Lasted in the evening about 4 hours after I got a small fever and chills.
I woke up with cold/flu like symptoms and severe vertigo on Sunday March 21 2021.  I could not even walk straight the vertigo was so severe.  Monday the cold symptoms were much better mostly fatigue and I still had vertigo but not as bad.  To this day I still have the vertigo.   When I get up or down from a laying position the room spins.  If I lean my head back even when I'm standing the room spins.  If I stand too long I get a fuzzy feeling.   My vision is also a bit cloudy than before.
Blood in the urine,urine looked like coffee; Body aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) had not resolved.            No Concomitant Medication was provided. It was reported that lab results and blood results were all in order and the only thing out of the ordinary was the blood in the urine.    This case was linked to MOD-2021-317574 (Patient Link).
Lymph nodes swelled abnormally causing substantial pain and affecting daily life/habits. Enlarged nodes presented on L underarm, L collarbone/clavicle, L and R sides of neck. One(1) node in L breast swelled for appx. 3 days, then reduced to normal. L underarm and L and R neck nodes swelled for appx. three (3) weeks before reducing to normal. L collarbone/clavicle reduce and enlarge intermittently from 04/02/21 to present. Pt takes OTC ibuprofen as needed, appx. 5x/week. Pt uses heating pad as needed. No other treatments provide relief. Physical manipulation of node sites produces pain.
32-year old male received first dose of Anthrax vaccine. He experienced flu like symptoms, sore throat, fever, body aches and fatigue.
expired shot of DTAP given 3/1/23. Given on 3/6/23
SERIES OF SMALL STROKES; TERRIBLE REACTIONS; SOUND IN HEAD; This spontaneous report received from a consumer via social media concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included patient was non- alcohol user, and non smoker.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose was administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced terrible reactions along with a sound in her head and a series of small strokes. She was always been healthy and now hospitalized. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible reactions, sound in head and series of small strokes was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210531420-Covid-19 vaccine ad26.cov2.s-Series of small strokes, Terrible reaction, sounds in head. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Flu like symptoms for two days. Raised, red, erythematous area about 2.5 inches in diameter. After two days the rash became more diffuse, but it is still hot and itchy.
Rash at injection site, hot to touch,  itches,  blotchy, 3 patches, hard to touch.