chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Light headed). At the time of the report, DIZZINESS (Light headed) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was unknown by the reporter.   No treatment information was provided.
On Day 8 after the vaccine, I started getting headaches, fever & chills, extreme tiredness. The headaches continue to persist through day 16.
upper lip felt numb; Upper lip felt tingling; bitter/metallic taste; Nausea; Loss of appetite; Tingling legs; Heart racing; Chest tightness; Light headedness and dizziness; chills and trembling (felt like low circulation); Overall exhaustion; This is a spontaneous report from a contactable consumer.   A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8743), via an unspecified route of administration in the left arm on 03Apr2021 at 17:45 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8743) as a single dose for COVID-19 immunisation.  Medical history included iodine allergy and allergy to melons. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) and vitamins (MANUFACTURER UNKNOWN); both taken for unspecified indications from an unknown date and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took epinephrine (MANUFACTURER UNKNOWN) on unknown dates for an unknown indication and experienced drug allergy.  On 03Apr2021 at 17:55, the patient experienced tingling legs, heart racing, chest tightness, light headedness and dizziness, and chills and trembling (felt like low circulation). On 03Apr2021 at 18:05, the patient experienced upper lip felt numb, upper lip felt tingling, bitter/metallic taste, nausea, and loss of appetite. After this on 03Apr2021, the patient had overall exhaustion. The patient did not receive any treatment for the events. The clinical outcomes of tingling legs, heart racing, chest tightness, light headedness and dizziness, and chills and trembling (felt like low circulation), upper lip felt numb, upper lip felt tingling, bitter/metallic taste, nausea, and loss of appetite, and fatigue, was recovered on unknown dates in Apr2021.    No follow-up attempts are required. No further information is expected.
MA mixed the solid component with sterile diluent instead of the liquid component also included in the box. Patient's mother was informed of the error and questions were answered. Patients mother was given the option to readminister vaccine correctly or return a later date. Mother decide to administer again
Significant worsening around mid May tinnitus, ringing of the ears, symptoms are ongoing, and unrelenting, there is no treatment available at this time for this condition.
Information has been received from a physician concerning a patient who on 24-APR-2009 was vaccinated with a dose of PNEUMOVAX (lot number not provided). On 25-APR-2009 the patient experienced fever of 101 Fahrenheit. The patient's arm swelled up. The outcome was unknown. Follow up information was received from the physician by phone indicated that out of 12 patients who received PNEUMOVAX from the same lot, 3 of the patients experienced adverse events. Follow up information was received from a physician via telephone on 06-MAY-2009. It was reported that the 80 year old female patient was vaccinated with a dose of PNEUMOVAX (lot# 662744/1085X) on 25-Apr-2009. Concomitant therapy included BENADRYL and TYLENOL. It was reported that the patient called the physician's office the next day (26-APR-2009) with a fever (102F) and swelling of the arm. On an unspecified date the patient recovered. This is one of several reports from the same source. No further information is available.
Patient presented to office for second Pfizer vaccine at 2:45. Was taken back to the room by vaccinator and given pediatric dose of vaccine although he was age 12 and should have received adult dosage based on age. At the time, vaccinator realized patients age and gave him an additional 0.1 ML of the pediatric  Pfizer vaccine totaling 15 mcg trying to remediate the lower dosage.  Pediatric and Adult dosages are different mcg/ML, resulting in the patient still not receiving the adequate dose.  Patient was given half adult dose and therefore under vaccinated.
Immediate pain upon injection followed by local redness, similar to cellulitis, some soreness between elbow and shoulder. Treated with AUGMENTIN, ZYRTEC (antihistamine) and steroid cream. Approximately two weeks for reaction to clear up.
Pt recv vax on 11/2/98; 1 hr later pt exp LA swelling, hard knot, red, hot at vax site w/ pain; tx=hot, moist cloth, Zyrtec, Tylenol
Headaches about 4 days, sore muscles about 4 days. Took Excedrin 1 time daily (PM use). Lump the size of a quarter at vaccination site. Down to size of a dime by next vaccination (5/20).
presented to his medical provider and was diagnosed with Cerebellar Stroke Despite receiving treatment; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot #, anatomical location, expiration date and route of administration were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly on an unspecified date, after receiving the zoster vaccine live (ZOSTAVAX), the pt suffered a stroke. The pt  presented to his medical provider and was diagnosed with Cerebellar Stroke Despite receiving treatment; It was reported that the pt continued to suffer the affects of his stroke. The reporter considered the cerebellar stroke to be related to Zoster Vaccine Live(ZOSTAVAX). Upon internal review, the cerebellar stroke was considered as a medically significant event.
Received her third in a series of HB vaccines at 2:34 pm on 3/10/04. At 5:15 pm 3/10/04 she reported an itchy rash on her forearms, worse on left than right. No history or problems with previous HBV immunizations. Diagnosed: Probable reaction to Hep B vaccine prescribed with Benadryl 50 mg every 4 hours as needed for itching.
4/25 - minor fatigue 4/26 - significant headache and fatigue 4/27 - minor fatigue, headache later in the evening 4/27 - minor fatigue  Ibuprofen helped to lessen the headaches
Information has been received from a health professional concerning an adult pt who in the last 30 days, approx Oct 2005, was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649914/0578P). In approx Oct 2005, over the last 30 days, the pt experienced an injection site reaction including redness, swelling and pain and was treated with diphenhydramine hc1 (Benadryl). The pt recovered in 3-7 days. It was also noted that this was a revaccination and the pt had at least one and possibly as many as 6 prior vaccinations before this dose. No product quality complaint was involved. Injection site redness, swelling and pain were considered to be immediately life threatening, disabling and other important medical event by the reporter (OMIC). Additional information has been requested.
Patient was administered an immunization for Rubella, and a TB skin test at the same time.  Approximately 40 hours later she reported swellling of her bottom lip and diarrhea.  (She had noticed the swelling to her lip on the previous day. )  Patient has a history of childhood allergies up until about ten years ago, and whenever she had a reaction it would elicit this type of response.  She was seen in the hospital emergency room for an evaluation and treatment.  The physician noted the swelling of her lower lip.  There was no edema intraorally.  Her lungs had a prolonged expiratory phase with mild expiratory wheezing.  The diagnosis was an allergic reaction with reactive airway component.  She was treated initially with hydroxyzine 50 mg, to be taken every 4-6 hours; and tagamet 400 mg up to t.i.d.   She was also given a peak flow meter to monitor her respiratory status.  She had no further problems and her reaction subsided after 24 hours.
Inflammatory reaction at site of smallpox vaccination (swelling, redness, pustular, axilla pain).
Swelling of the injection area, arm turned red, shortness of breath then difficulty breathing, fast heart beat, dizziness and weakness.
Fever, chills, nauseous, sore muscles, swollen lymphnodes, ear ache, swollen/sore throat, eyes swollen
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 05-NOV-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 671075/1197AA, exp. date: 25-OCT-2012). No adverse symptoms reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Diffuse pruritic rash on face, upper back, chest, and arms. Patient woke up with the rash, which seemed to get better as the day went by, but then the next night woke up with significant itchiness due to flare-up of rash again. At time of appointment (within 48 hours of initial rash), diffuse patchy erythematous blanching noted.
Client received rabies (IMOVAX) dose 1 and 2 IM 8/7/08 and 8/14/08. Symptoms of tingling in (L) foot and leg started after start of series and progressed to pain. Saw MD who ruled out DVT. Reevaluation on 8/29/08. Dr not sure vaccine related.
About 5 minutes after administration of the Moderna vaccine (dose 1) patient appeared to have a seizure. She was seated in a chair and we noticed she started having an issue when she dropped her phone, her back and arms became very stiff, and she proceeded to have convulsions.  We called 911 and lowered her on the ground and she continued to have convulsions for about a minute. She then slowly regained consciousness and asked us what had happened. Patient reported feeling confused and dizzy immediately after and said she had ringing in the ears. EMTs arrived on the scene and ended up taking the patient to a nearby hospital for evaluation.
Low grade fever, muscle aches, headache, dizziness, extreme soreness at injection site, and general malaise / extreme fatigue at 5-6 hours post vaccination
Information has been received from a physician concerning a female patient who on unspecified date was vaccinated with the second dose of GARDASIL (lot number, expiration date and site of administration not reported). On unspecified date, after receiving the second dose, the patient experienced and extremely bad headache and went to a neurologist. When the patient returned to the primary care physician the patient's mother shared that the neurologist recommended against getting the third dose as the headache was borderline migraine. The series of GARDASIL vaccine would be discontinued. At the time of the report, the patient's outcome was unknown. No further information is available.
Pfizer 2/5 and 3/4. Positive on 12/13
ADMITTED TO HOSPITAL FROM ED WITH COVID-19 AFFECTING PREGNANCY. (SHORT OF BREATH)  DIAGNOSED WITH COVID 19 ON 2/3/2022. RELEASED FROM HOSPITAL SAME DAY WITHOUT SEQUELAE
Infant had reddened areas on right side of head & redness on right side of cheek.  Her primary physician was notified & mother took infant upstairs to his office per his request.  Rxn came back within 30 minutes & said M.D. had given 0 meds, but he will do further vaccines individually.  Per mother had resolved.  Per mother at M.D. office symptoms lasted < 30 minutes.  0 sob, 0 coughing, 0 hives, 0 swelling, 0 wheezing, observed.
Half-dollar sized red rash on triceps area. Painful and inflamed. Rash was not at site of injection.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Concentration, dose and route were not reported), lot # L039660, expiration date 04-FEB-2018. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
For the day of the injection and the next, I had increased fatigue (I'm a Covid-19 "long hauler" since testing positive for it on 01/22/2021, and fatigue and brain fog are my biggest long-term symptoms), chills, a light headache, and muscle aches, and soreness in the arm that received the injection. These began after the vaccine was administered on 04/11/2021 and resolved by 4/13/2021. However, on approximately 04/28/2021 I began getting itchy, raised hives, but only on the arm that received the vaccine. The hives don't stay in one place on my arm, and they leave behind dark red-to-purple pin-prick marks under the skin, perhaps from all the scratching. I use cortizone topical cream to reduce the itchiness and have been taking diphenhydramine (Benadryl), both of which provide some relief for a few hours, but the relief is frustratingly brief. The hives come right back again. It still hasn't resolved.
fever,  chills, nausea, congestion, bad  headache, aching muscles, especially neck and shoulders but also both arms (not only tax arm) and legs, , sore throat,  and exhaustion- all except the fever continuing for 7 days.   I took two covid tests toward the end because I was worried and didn't want to make others sick.  .  Both were negative.
Patient currently has a negative VZV IgG level.; Route of Administration: IM; acute cerebellar ataxia/ cerebellitis confirmed on MRI; This spontaneous report was received from a physician and refers to a currently 18-years-old female patient. The patient had none pertinent medical history and none concomitant medication. No known drug allergies (NKDA) was reported.  On an unknown date in 2003, reported as 18 years ago, the patient as an infant was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 injection, intramuscularly (incorrect route of product administration) for varicella zoster virus (VZV) prophylaxis (exact dose, anatomical location, lot# and expiration date were not reported).  Within 10 days of receiving the vaccine, the patient experienced acute cerebellar ataxia/ cerebellitis (encephalitis) confirmed on magnetic resonance imaging (MRI) (date not reported). The patient sought medical attention and received "supportive management", other treatments (if any) were unknown by reporter (he was not involved in the patient's care at the time). The reporter stated, that there were no isolates from the event available, nor was the medication vial available. On an unknown date, reported as currently, she had a negative VZV IgG level (antibody test negative).  The outcome of acute cerebellar ataxia/ cerebellitis was reported as recovered on an unknown date. The outcome of negative VZV IgG level was not recovered. Action taken with varicella virus vaccine live (oka/merck) (VARIVAX) was reported as not applicable, however no further doses were administered.  The relatedness between acute cerebellar ataxia/ cerebellitis and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown as they could not definitively trace the symptoms to the vaccine administration at the time of the event. The causality assessment between the negative VZV IgG level and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  The reporter considered the case as non-serious, but upon internal review, the event of cerebellitis was determined to be medically significant.
that evening staring szs-lasted 1-2mins p/that sleepy but no further szs or adverse events;hx of sz & juvenile diabetes;
Guillan Barre Syndrome, confirmed on LP. LE weakness, confusion and difficulty ambulating
Moderna Covid-19 vaccine EUA.  Swollen arm with redness, warmth and itchiness.   Currently in fifth and is starting to dissipate.
Patient is a 17 year old male presenting with post-vaccine myocarditis. He had his second dose of his Pfizer COVID vaccine 3 days ago (6/11/2021) and that evening felt some mild burning central chest pain. States that the pain has been intermittent since then, non-pleuritic, non-exertional, but last night he had a severe episode that woke him from sleep, so his mother called the pediatrician who recommended he come to the ED. ED Course: Vitals - T: 36.7 °C, P: 79, R: 20, BP: 119/73, O2 SAT: 98% RA EKG - NSR 74, no acute abnormalities CXR - no acute process Trop - 32 Echo - normal  PICU Course Cards: Troponin downtrending from 32.7 => 25.3 => 22 => 23.1 at time of discharge.  Has been without chest pain during admission.  Cardiac MRI demonstrating "Subepicardial delayed gadolinium enhancement in the mid inferolateral wall consistent with suspected diagnosis of acute myocarditis. Normal biventricular size and function with no hypertrophy.  Normal valve function and structure."  He will follow up with cardiology on 7/12 with repeat troponin on 6/18.  EKG and ECHO unremarkable.    ID: CBC, CRP unremarkable.  Enterovirus PCR and RPP Negative.  COVID-19 PCR Negative.  COVID-19 IgG negative.  Afebrile though out admission.
High fever for 1 day (105-107). For the following week, swollen lymph nodes, loss of voice, spiking fevers at night, night sweats, chills, body pain (localized to hips and below, ringing in ears, and insomnia. Some symptoms still ongoing.
Severe left armpit pain began on March 2, 2022 and lasted for 4 days. Pain was constant and became worse with any pressure on my underarm and with attempting to sleep on my left side. Moderate swelling of left armpit began on March 3 in the late morning and lasted for 3 days. Left arm soreness and left sided chest soreness were moderate-severe and began on March 3 and lasted for 3 days.
Had soreness in her arm; This is a spontaneous report from a non-contactable consumer or other non HCP (patient, self-reporting). An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that a friend shared that her adult daughter had soreness in her arm after the first does of the vaccine.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
11/16/2007  7:30 am patient had episode of spinning-head tilted to r-then whole body shaking lasting less than 2 minutes- no fever- EMS called and taken to ER- ?partial complex seizure vs syncopal episode.  Transferred to Hospital for further evaluation. Discharged home on 11/18/2007.  On 11/20/2007 mom called to say that patient had another seizure.  She returned to hospital and was begun on depakote. 1/2/08-records received for DOS 11/16-11/18/07-DC DX: Seizure. One episode of eye twitching. Per parent happened 3 times, collapssed. No post ictal state. 1/2/08-records received for DOS 11/16-11/18/07-DC DX seizure.  Morning of ER visit found on floor.  Per 60 day follow up: Patient diagnosed with generalized epilepsy by neurologists. MRI brain- normal. She is being treated with DEPAKOTE ER 500 mg qhs. R/C in EEG consistent iwth genralized motor epilepsy.
The caller reported an AE for MMRII. The caller said the patient received a dose of MMRII on 12/20/2017 and developed a rash. The caller said they were unsure if the rash was related to MMRII or Amoxicillin, because the patient received both products; This spontaneous report was received from Other Health Professional and refers to a 15-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 20-DEC-2017, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  amoxicillin (AMOXICILLIN), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient developed a rash. The caller said they were unsure if the rash was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or Amoxicillin, because the patient received both products. The caller was unable to confirm a date for when the rash developed. The caller said that she did not have any further information about the patient, but the caller provided consent for follow up. AE letter sent to caller. No other AE. No PQC. At the time of reporting, the outcome of the event rash was not known. The action taken with M-M-R II regarding rash was reported as Not Applicable.   The causal relationship between rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
headache; This is a spontaneous report from a contactable other hcp. A 61-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 61-years-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil (OMEGA-3 FISH OIL) 1000 mg capsule, paracetamol (TYLENOL) 325 mg tablet, nifedipine 10 mg capsule, hydroxychloroquine sulfate, methotrexate 2.5 mg tablet. On an unspecified date, patient stated she had a slight headache after her COVID vaccine last month. Patient held a dose due to vaccination and MD not aware. The outcome of the event was recovered.  No follow up attempts are possible. No further information is expected.
BODY RASH; TINGLING IN MOUTH; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced body rash, and tingling in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body rash, and tingling in mouth. This report was non-serious.
Patient experienced arm pain and swollen lymph nodes about 2-5 hours after shot was given. She experienced swelling of the throat that night (it was uncomfortable but did not limit breathing and no EpiPen was used). Patient also felt numbing on the feet near ankle area. Pt did have a doctor visit. These adverse effects lasted about 10 days. Pt did come back for second dose.
Vaccine given 12/17/07, developed hives per mom that evening on arms, neck and torso. Given antihistamine with resolution of symptoms.