chrisvoncsefalvay/vaers-outcomes huggingface dataset:
didn't feel well; Headache/ wake up next morning with the headache; neck stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck stiffness), MALAISE (didn't feel well) and HEADACHE (Headache/ wake up next morning with the headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck stiffness) and HEADACHE (Headache/ wake up next morning with the headache). On 04-Mar-2021, the patient experienced MALAISE (didn't feel well). On 06-Mar-2021, MUSCULOSKELETAL STIFFNESS (neck stiffness), MALAISE (didn't feel well) and HEADACHE (Headache/ wake up next morning with the headache) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  Patient have medical history of lupus since 1979.   This case was linked to MOD-2021-333577, MOD-2021-333670 (Patient Link).
I experienced severe pain in my arm for 2.5 days. I could not even move my right arm because it was too painful.  Four days later, up to this day, I started feeling a pain under my right breast, in the area of the base of my breast and chest wall.  It hurts when I stretch my body and my right arm and upon standing from a sitting position.
No adverse event from the vaccine. Reporting due to the fact Janssan COVID vaccine is 18 year and up, but was given to a 12 year old. Talked with with after error was realized. No adverse effects from the vaccine other than the normal low grade fever.
I had no reaction after getting the vaccine. Only the usual symptoms. On March I found a tick in my bed and in my arm. The tick did not get engorged but was embedded. I almost had a heart attack because I was so scared. I did not want to go to the ER in the middle of the pandemic. I did not know where to go because everything was closed. Recently I have had high blood pressure, heart palpitations, and irregular heartbeat. That happens occasionally. Even more than once a day. It starts out of the blue. I saw my doctor on 07/01/2021 and she got a Limes disease test because I told her about the tick, and I told her the palpitations got very bad at that time. It came back negative. She did a blood test and was normal. I cut on caffeine and that seems to help a lot. I think it is just stress, that is my personal feeling. They did not prescribed any medications for my heart only for the tick.
This spontaneous report as received from a nurse refers to a 15 months old male patient with none medical history and none drug allergies. The patient was subcutaneously vaccinated with 0.5 ml M-M-R II (lot# reported as 0288AE) on 03-DEC-2012. Concomitant medications included: AMOXIL and completed one week ago before vaccination. In December 2012 the patient experienced rash from head to toe. Certain areas of patient's body, both cheeks, back of both arms, upper part of both thighs have welts like rash and rest of the body is covered with generalized papular fine rash. Physician diagnosed rash as "measles type rash". Patient was taken to an immediate care clinic on unspecified date and BENADRYL was given for the adverse event. None lab diagnostics was performed. The outcome of the adverse events was unknown at the time of report. Additional information is not expected.
Sick as a dog; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick as a dog). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient got her/his first shingles shot, made her/him sick as a dog.  The patient won't be getting the second one. that's even stronger than the first. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
nausea, dizziness, headache. body aches, fever of 101.9.
Fever -99 2 day after shot 5x6 cm area induration warm red tender with surrounding erythema whole deltoid
Bloody nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20May2021 19:20 (Lot number: EW0182) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious) with onset 20May2021 21:00, outcome "recovered" (2021), described as "Bloody nose". Therapeutic measures were not taken as a result of epistaxis. Additional information: The patient's prior vaccinations were none. The patient's relevant tests were none. No follow-up attempts are possible. No further information is expected.
pt stated before vaccine that she had what she thought was a mild allergic reaction after 1st dose. she talked to dr and they stated to get 2nd dose anyways, take some benadryl and take her epipen with her. we went ahead and gave the vaccine and monitored patient.  within 5 minutes she stated her heart was racing and her ears felt hot. her HR got up to 136 and over 15 minutes went back down to 90. She became flush and staed that her tongue and mouth felt funny and thick. she had no issues with breathing. I instructed her to take a benadryl tablet he had with her. I provided water and juice for her. she stated her feet felt funny as well. after 20 minutes she developed a red rash on her neck and was hot to the touch as well and her face was red.  She made a call for family to come drive her home and i then instructed her to take another benadryl.  after 30-40 minutes of monitoring patient felt like she could go home and was instructed to follow up with dr or er if symptoms got worse and to use epi pen if necessary.  I made a call to her primary dr to document reaction and advise how we handled situation.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported0. The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 72 hours, with the lowest recorded temperature of 28 degrees Fahrenheit (-2.222222222 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Pt claims that her kidnesys malfuncioned and she suffered liver issues. She states that both legs swelled up and she had  fever. Vaccines administered on 11/04/2004, But pt c/o 12/16/2004.
Breakthrough case admission after 2 vaccines Moderna 4/9/21 lot# 025B21A;  Moderna 5/5/21 Lot# 048B21A
1 day following vaccination, c/o redness, swelling @ injection site, chest tightness, malaise, Seen by doctor, dxed with localized granuloma systemic reaction, Rxed dicloxacillin
Arm felt very sore for 2 days after the shot, felt feverish, body was very warm.
Chills, Aches (neck, arms, back), dizziness, symptoms are  similar to the flu
On 6/8, he developed fever and chills. On 6/9, he developed shortness of breath, dizziness, increased HR while playing golf. Rested and symptoms improved. Resting HR at the time of my call with him was in the 80s, but he reported low 100s when he was playing golf. Symptoms resolved with rest and hydration only. He did not need to go to the ER or be hospitalized.
pt recvd vax;vascular purpura appeared in ankle;pt had febrile episodes, chills & sweats;skin biopsy revealed leukocytoclastic vasculitis;exacerbation of skin lesion;wt loss;septal cellulitis;erythematous sclerodermiform;fibrinoid necrosis;
Fever to 102 the 1-2 day following vaccine which self resolved. 3 weeks later, patient developed recurrence of zoster-associated stromal keratitis. He had diffuse stromal edema, anterior stromal granular infiltrate, and keratic precipitates. The inflammation resolved with topical steroid eyedrops. As a result of this recurrence, he had pain and decreased vision from 20/40 to counting fingers which eventually improved back to baseline with treatment. He is left with evidence of inactive scarring at last exam 9/10/18.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 24-NOV-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot number J006082 and expiry date 12-APR-2014) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 and the outcome of the event was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. No product quality issue was reported. Additional information has been requested.
Large swelling at point of injection (red & itchy) All joints in bodyached muscular aches extreme tiredness symptoms appeared sudenly came on in secondary, treating w/ vicopin & Ibuprofen to ease symptoms
Started to break out in a rash on his wrist, hands feet and a little on his back. At the injection sight it is 102 degrees. Both hands have started to swell.
Vaccination #1, Immediately after the 1st injection had the normal arm soreness and then body aches for 3 days and no fever.  BUT then 13 days later my arm at the injection site started itching and getting red.  The next morning (14 days after injection) I woke up with a huge knot on my arm at the site of injection about the size of a baseball.  It was bright red and extremely painful and sensitive such that I couldn't tough my arm and my shirt sleeve bothered my arm.  The knot and soreness finally went away after 3 days.  I still have a dark spot on my arm.  Vaccination #2, I had very mild arm soreness but the next day had fever and horrible body aches.  The fever started at 99.6 and spiked that evening at 102.  The next morning I woke up fine with no symptoms.  BUT ever since the 2nd injection I have been experiencing a fair amount of Dizziness.  Sometimes its mild, other times it such that I have to grab onto something to keep from falling.
Vaccine sprayed in the eye; Vaccine sprayed in the eye; This case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a female patient who received Herpes zoster (Shingrix) (batch number 95G27, expiry date 10th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: The pharmacist reported that she was administering the vaccine and the syringe malfunctioned.  The vaccine sprayed her in the eye. Related to patient. Chat was abandoned prior to getting more detail, email and contact number above was what she provided. Chat was picked up by another agent after health care professional reconnected where health care professional provided vaccine name, lot and exp date, she declined to provide her date of birth. The reported mentioned to saw case chat transcript if needed. Additional Supportive Information: The vaccine was sprayed in the patient eye, which led to inadvertent exposure to vaccine and exposure via eye contact.
throat tightness , throat itching  f/u call made; caller reports throat still sore and feels swollen, but able to swallow soft foods and liquids; continues to take allergy med and tylenol; unable to take Ibprofren d/t intolerance
This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # M000998, expiration date: 07-JAN-2018, dose and route of administration were not provided) that were improperly stored. No adverse effect were reported. Additional information has been requested.
Patient suspected he was going to receive Moderna Vaccine. Felt staff at registration and vaccination station did not adequately alert patient of which vaccine he was being given until after vaccine was already administered. Patient adamant he wasn't given adequate opportunity to be informed prior to receipt of vaccine. The patient did schedule for the appointment using County online application. Review of situation with all staff involved-Vaccine station - clinician administering vaccine as well as support staff assisting with entering information into electronic system both noted that they notified the patient which vaccine he was going to receive prior to administration of the vaccine.
Blood pressure went up to 162/109, heart rate went up to 142 for 3 hours, took extra blood pressure pill and drank water, back to normal in 3 hours.
Headache FATIGUE, PSIN/SWELL INJ SITE, RUNNY NOSE Narrative:
Patient was given Pediarix vaccine instead of Hib , also received another dose of Dtap (Infanrix) on the same visit.
Croup; Respiratory virus; This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported similar events for three patients. This is the first of three reports. Only this case is serious.  A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 14May2021 17:00 (Batch/Lot Number: EW0182) (at the age of 13 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Prior vaccinations within 4 weeks was none. The patient experienced Respiratory virus which led to croup on 27May2021 with outcome of recovered on 31May2021. Therapeutic measures were taken as a result of events. Prednisolone and Benadryl were used. Household (Father, Mother, Patient) all contracted a respiratory virus. Patient was not tested for COVID-19. Patient was susceptible to croup when he contracts respiratory viruses. On the evening of 22May, his croup was so bad it necessitated a dose of Prednisolone which was kept on hand for emergencies. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101046560 same reporter and drug, similar event, different patient;US-PFIZER INC-202101046571 same reporter and drug, similar event, different patient
My husband began feeling ill on Thursday 06/23. He tested himself for COVID-19 and was negative. He retested on Friday morning and was Positive. On Monday morning at 3am I was feeling badly with a sore throat, itchy ears and eyes. I tested myself and was positive. I immediately began taking Paxlovid. I have been congested, tired, short of breath on exertion and have had a stuffy nose. All of my symptoms have been mild to this point.
Shoulder mobility decreased, unable to lift vertically or horizontally up past breast height/ muscle spasms in shoulder area and occasionally radiating  to neck/fingers on let hand are curling inward towards palm.
Reoccurring cluster migraine headaches.  No medical diagnosis due to history of adverse event.  Headaches occur generally around the same time each day, 9:30 PM.  Headaches last around  1 1/2 hours.  This headache cycle lasted until 4/29/2021 (day after 2nd vaccination shot).
Chills Aches Headache  Cough Low grade temperature  Hard bump & redness at injection site. (Warm to the touch) Symptoms lasted approximately 24 hrs; injection site still red three days after injection
I was diagnosed with shingles two days after the first shot with symptoms beginning 6 hours after the first shot.
48 hours after receiving Flu shot and Hep A vaccine high fever and seizure occurred. Taken by ambulance to Red Cedar Medical Center. Follow up needed.  MR received detailing an ER visit of a healthy almost 2 year old who appeared to have a generalized seizure which lasted about 2 minutes, 2 days s/p flu and Hep A vax.. Brought in by ambulance with a temp. of 103.4'F rectally. PE was normal although child was subdued possibly due to being post-ictal.  F/U one week later shows no further problems. Assessment:  Febrile Seizure.
FEELING AWFUL; BEACH ACHE; COULDN'T FUNCTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 admin not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced couldn't function. On 12-MAR-2021, the patient experienced feeling awful. On 12-MAR-2021, the patient experienced beach ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling awful, beach ache and couldn't function was not reported. This report was non-serious.
Pfizer vaccine vial diluted with an additional 1.8 mL NS of diluent after proper dilution of 1.8 mL NS.  To maintain proper 30mcg dosage, 0.6mL doses were administered x6 versus the normal dilution ratio of 30mcg per 0.3mL.  Recipients' vaccine cards annotated as receiving 30mcg versus 0.3mL.  Involved recipients unknown.  No issues observed with administration of the 0.6mL/30mcg.
chills, shaking, achy, headache, vomiting  Narrative: Took OTC Tylenol
Patient stated that he felt light headed right after he got the shot when he got up. Vitals taken,  gave water.  Patient stated he feels much better and left at 1045.
Presented with heahache Head CT showed dural sinus venous thrombosis currently treated with argatroban
Severe itching, swelling and purple discoloration of the entire right shoulder, deltoid, and bicep with pain noted in the axilla.
approx 2wk p/vax pt broke out w/150 pox over body;also had low grade fever;parents unaware of any other exposure to chickenpox;has had no problems w/immun system that parent are aware of;
Severe pain/ache in arm and loss of strength in hand, pain going down my left side of body.
Patient stated that immediately after getting the shot that she started feeling nauseous. She started to feel better she said so she went home and then felt dizzy or off for a while.   She also states that she has lost the ability to smell and still hasn't regained it.  She can taste just not smell.
got the worst of the symptoms and post COVID symptoms; got the worst of the symptoms and post COVID symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got the worst of the symptoms and post COVID symptoms".  Clinical course: The patient stated, "I liked it because I really like withheld; but when I got COVID; opposed to my other family who were not vaccinated; I got the worst of the symptoms and post COVID symptoms; they barely got any symptoms." Reporter considered that event as caused by suspect product    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 18 hours after 2nd COVID vaccine, patient developed sudden loss of hearing in the right ear, accompanied by tinnitus and vertigo and feeling of fullness in the right side of her head.
Engerix-B Pediatric dose to an adult patient; Engerix-B Pediatric dose to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B Pediatric dose to an adult patient) and adult use of a child product (Verbatim: Engerix-B Pediatric dose to an adult patient).The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter called to ask for information about the administration of a pediatric Engerix-B dose to an adult patient, which led to underdose and adult use of a child product. The reporter asked how to proceed with this patient. The reported did not provide information about the patient and mentioned that she did not know the date of administration. The reporter consented to follow up via email.
At day 5-6 after the Shingrix vaccine I developed burning arthralgia in my hip and knees and rash on my leg.  These symptoms were not present before the vaccine.  I had shingles in my 20's, I am familiar with post infection pain.  This was not the ordinary dull ache or pain of and stiffness of arthritis that does away during the day.  It is burning pain that prevents sleep and is excruciating.  Tylenol did not dull the pain.  In addition, bowel activity (once regular) came to a slow down.  4-5 days no BM.  Using senna tablets for assistance.  Seems to be tied to vaccine event and not coincidental.