chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 mins after the shot my throat started burning, heart pounding, shaking uncontrollably, throat felt like it was sticking together, dizzy, lost all my color, hives, tunnel vision, kept almost passing out. Medical personal on site hooked me up to a blood pressure machine. Tested my sugar. My blood pressure was high. They gave me a shot of Benadryl in my left arm. Symptoms seemed to improve for a few minutes. Then came right back. I was going to pass out so they laid me down and called 911. I was rushed to the Emergency Room. Symptoms persisted and they gave me a shot of ephedrine, steroid, and Pepcid.  I was kept for observation and sent home with two prescriptions. EpiPen's and steroids. My symptoms persist even to this day. I still do not feel right. My hives have pretty much gone away but I am still feeling off balance and unwell.
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; No additional AE; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, dose number, route of administration and anatomical location were not provided) (lot#: W032370, expiration date: 10-OCT-2024) as prophylaxis (product storage error). No adverse event was reported. The temperature excursion was 24.4 F for a total timeframe of 5 hours and 51 minutes. No previous temperature excursion were reported. No further information was provided.
felt tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (felt tired) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.     The patient never had COVID positive test or diagnosis. The patient did not receive any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number: EW0150) on 03-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2, Lot number:EW0169) on 24-Apr-2021, Novavax vaccine (Dose 1 experimental vaccine received in early 2021) in 2021 and Novavax vaccine (Dose 2 experimental vaccine received in early 2021) in 2021. Past adverse reactions to the above products included No adverse event with Novavax vaccine, Novavax vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy, Allergic to cats, Reactive airways disease and Asthma (After receiving the vaccine his breathing felt a little like depressed. But he went to sleep and woke up okay.). Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for Prophylaxis against AIDS.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced FATIGUE (felt tired). At the time of the report, FATIGUE (felt tired) had not resolved.            After receiving the first Moderna Booster dose the patient felt tired and was in bed for a day or two. This adverse event did not cause patient to seek medical care. The patient did not experience similar events in the past.  No treatment details were reported.   This case was linked to MOD-2022-644995 (Patient Link).
libido decreased; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 28-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: LIBIDO DECREASED (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore arm began within an hour of vaccine. Chills began 5 hours later. Overnight arm was painful. By 5:00 a.m. I was clammy and feverish with body aches and strong headache.  By noon that day the fever went away but headache and body aches persisted until later that evening.  By next a.m. I felt fine with no side effects at all.
Patient was nervous before receiving the vaccine. During the 15min post vaccination period, patient started getting dizzy and looked like he was about to faint so the pharmacy staff ran out to observe his blood pressure and any signs of anaphylaxis. Blood pressure and breathing were normal. Patient was given water and the ambulance was called. They also monitored his blood pressure/breathing. After 20 minutes, patient was normal and was able to leave with his parent.
This spontaneous report as received from a nurse via company representative refers to a 14 year old male patient with an allergic rhinitis. The patient's medical history included hives. He had no drug allergies or reactions. On 05-NOV-2013, the patient received the first "standard dose" 0.5ml of GARDASIL (lot #, expiration date and route were unspecified) with "no issues". On 24-JAN-2014, the patient received the 2nd "standard dose" 0.5ml of GARDASIL intramuscular (lot # J012212, expiration date: 18-FEB-2016, dose unspecified). Concomitant medications were not reported. On approximately 31-JAN-2014 (reported as "a week later"), the patient developed hives. The patient was seen at the office, on an unspecified date, and was given ZYRTEC (dose and frequency unspecified) for treatment. The patient's status, at the time of the report, was stated by the reporter that he had persistent hives. The outcome of hives was reported as not recovered/not resolved. The relatedness between hives and vaccination with GARDASIL was unknown. The patient sought medical attention. No lab diagnostics studies were performed. Additional information has been requested.
The pt experienced a large bright red raised circle with a white blotch in the middle at the injection site. Child unable to walk on her leg for 3 days. The pt was given Benadryl.
It began with normal fevers, and then they intensified, fever rose and fell. I took her to the facility so they can check her. The fevers rose to 102-104 degrees F. The fever was controlled and I would take her home, this continued for a week, and the week after she developed  Bronchiolitis.  For the fever they used Tylenol. For the bronchiolitis, they used Pulmacol therapies.
Started out with both shots 1 & 2 with lite headedness and nausea.  Sore arm on both shots for 48 hours.  2nd shot started with a tingling burning sensation in legs up to stomach for the first 12 hours.  2nd shot had lack of energy and chills after 24 hours.
No adverse effects reported; the rubber stopper of the VARIVAX was punctured to reconstitute the product and it "dripped out" of the top of the vial; it "dripped out onto her hand through a hole in the top of the vial"; it "dripped out onto her hand through a hole in the top of the vial"; it "dripped out onto her hand through a hole in the top of the vial"; Could a full dose be withdrawn? NO; This spontaneous report was received from the field employee referring to a patient of unknown age or gender.  The patient's concurrent conditions, historical conditions, drug reactions, and allergies were not provided. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 02-MAY-2019, the patient, who was also the medical assistant, was aspirating a vial of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R022115 (expiration date 02-AUG-2020) (dose, frequency, strength, anatomical location or route of administration were not provided) and it "dripped out onto her hand through a hole in the top of the vial" (occupational exposure to product, accidental exposure to product, and exposure via skin contact).  The physician and medical assistant reported to the field employee that the rubber stopper of the varicella virus vaccine live (Oka/Merck) (VARIVAX) was punctured to reconstitute the product and it "dripped out" of the top of the vial (product container issue). It was reported tat a full dose could not be withdrawn, the quantity is unknown by reporter, but it was less than a full dose (circumstance or information capable of leading to medication error); however, the unspecified patient did not miss a dose. No more clarifying information was provided. Product would be able to be retrieved.  No adverse effects reported. No additional information provided.   The action taken regarding the event was not applicable.  The outcome of the event and causal relationship between the product container issue and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Arm inflammation, soreness and pain starting 5 minutes after injection. Pain worsened the next day.  Slight headache and general body soreness and tiredness started about 30 minutes after vaccination and continued until slightly under 24 hours after vaccination. Fever, intense chills, skin sensitivity causing pain to the slightest touch or grazing of the skin, especially in the skin of hands (both) and ears. This woke me up at 11:57pm the same night of vaccination, about 14.5 hours after injection. I fell asleep again and woke up at two hours later, at 2:02am, the fever, skin sensitivity and chills were gone. I was drenched in cold sweat when I woke up. The pain in the arm persisted.   24 hours after the injection the only symptom left is the sharp pain and stiffness of the arm in the injection site.
Injection site swelling and extreme soreness Fatigue Stomach cramping  Nauseous  Chills Muscle aches Migrane
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). The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about November 2016, a pharmacist administered the ZOSTAVAX (lot# and route unknown) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about December 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles  and zoster-related injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
On 01/22/2021 body aches all over. 01/23/2021 both eyes were almost swollen completely shut but no more body aches just in the shot area. It was scary. The swelling went slowly down throughout the day. 01/24/2021 am the swelling seemed to be all gone.
Patient received 1st dose of Heplisav-B while 9 weeks pregnant. She was required by her employer to have the vaccination.  After vaccination was given, found out that Heplisav-B is not indicated for pregnant women and they can only be given energix-b, recombivax, or twinrix. Patient was given the information for manufacturer and encouraged to call to discuss the risk summary.
His a 21yo navy recruit that present after yellow fever vaccine.  Pt noted sweating, palpatations, weakness, dyspnea, and hives immediately after yellow fever vaccine and was given epinephrine and benadryl; which ameliorated pt complaints.  After stabilization pt was then sent to hospital for further evaluation and admitted to the internal medicine service for observation.  2/9/09 MR received for DOS 1/8-9/2009 with D/C DX:  Anaphylaxis Reaction after Yellow Fever Vaccination.  Pt presented after receiving YF vaccine where pt immediately developed sweating, palpitations, weakness, dyspnea and itchy hives.   Given epi and Benadryl on site, sent to clinic and admitted for further observation. Tx- epi, solumedrol, Benadryl and Zantac. Asymptomatic upon arrival in ED. Observed o/n with no further episodes.
4hr p/vax 4-5hr of inconsolable crying by rash & trip to ER;rash was fine rash & disappeared a/seen by md;T103;dx ear infect;
Sore and sensitive arm for 12 days at sight of injection and surrounding tissue, slept for 30 hours after injection. The first 6 hours were normal other than soreness in the arm. Extreme fatigue for 48 hours, body aches for 48 hours, low grade fever for 48 hours, foggy  cognitive processing for 14 days, nausea, chills and general feeling of illness or being "run down for 72 hours. Was not back to full normal strength and mental clarity for 21 days.
Client reported had redness, swelling L upper arm; spasms in back of head and down neck which began on 12/17/02. Client at HD 12/20 for PPD read and no redness, swelling observed. Hx panic/anxiety attacks and client takes Paxil for. Client reports has had spasms before if doesn't take Paxil regularly.
Pt c/o L arm redness, soreness, itchiness 6 days after TDAP in left arm. No fever.
Pt vaccinated with TD developed tenderness & swelling lt upper arm. Local pain at injection site.
Pt received 1st dose of DTaP at 16 mo due to parent apprehension that father had reaction to DTP vaccine as a child.  Patient has had Hib and Prevnar in the past without incident.  On the day of vaccine, pt developed extreme fussiness and irritability along with fever.  Pt did not have any other vaccine except DTaP. His exam was normal with no source for his fever. He also had emesis x 3.
Very tired by noon every day, pain between shoulder blades, leg pins and needles, chills, headaches, no energy, then turned into vertigo for a month. Sick for a total  of3.5 months. Still having problems from the ongoing vertigo in focus and brain lethargy.
Pt received flu vaccine (L) upper arm on 11/9/16. Seen in office 11/10/16 for localized redness and swelling. Area of erythema 7.5 cm diameter. Pt otherwise well.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Day2, vision obstruction with what looked like waves of water, and again on day 10, same symptoms. Essential vision loss since the waves were taking over the whole pupil
05/13/1999, shortly post onset of symptoms, this 45-year-old female received second dose received Indocin ER 75 mg 1-2 qd for pain. Her heels have been as painful as her right arm and wrist. She has felt quite tired and is sleeping very poorly. She has been depressed but not suicidal.  06/27/1999 urgent care visit pt with left arm pain for several days. There was no history of trauma. She is right-handed. Pain is worst at elbow but radiated to wrist and shoulder. The area was very tender and slightly swollen. She denied that deep tan/burn is recent. The patient's only medication was Meridia. Impression: left lateral epicondylitis with probable extensor tendonitis at wrist also. Prescribed: sling, elevation and Indocin 25mg, two capsules PO tid for two days then one capsule tid. Diagnosis: tendonitis/capsulitis/periarthritis left elbow. 05/09/2000 Diagnosis: chronic lateral humeral epicondylitis. The patient had debridement of her left lateral humerus epicondyle performed three days ago. At the time of her surgery, her conjoint tendon was reflected and holes were drilled lateral humerus epicondyle. She did well post-operatively but had some problems with post-operative pain. The surgery helped relieve her pre-operative pain.  April 21, 2000 office visit: Assessment: the patient had sleep deprivation, wide spread aches and pains, and an element of depression. There was no evidence of synovitis on examination. To the physician, her symptoms were strongly suggestive of fibromyalgia. The patient was prescibed trazodone.  Lymerix was discontinued.  The most recent information received 06/12 reports the condition of the vaccinee as ongoing.
Redness in right arm, warmth, chills, nausea, malaise, pain in arm.
Headache; dizziness; High blood pressure; Fever; general body aches; Migraine; extreme fatigue; Diarrhea; Rash on injection site; pain on injection arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on 24Apr2021 at 10:00 (Batch/Lot Number: EW0171) as dose 2, single for covid-19 immunization (at the age of 44-years-old). Medical history included asthma, osteoarthritis and covid-19 (prior vaccination) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in left arm on 22Mar2021 at 04:00 pm (Batch/Lot Number: EP6958) as single for covid-19 immunization (at the age of 44-years-old). Patient also took morphine and experienced allergy previously. It was reported that within 10 hours after receiving second dose of vaccine on 24Apr2021, the patient experienced fever, general body aches, migraine, extreme fatigue, diarrhea, rash on injection site and pain on injection arm. After 2 days on 26Apr2021 experienced headache, dizziness, diarrhea, and high blood pressure. Patient was treated with Imitrex, Tylenol which mildly helped. Patient was tested COVID post vaccination. The outcome of the events was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y) IM. The patient experienced redness and swelling at the injection site after receiving the dose of PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 03Oct2013; WELLBUTRIN, start date: 10Sep2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient received treatment with Paxovid (Lot: Ga5120) on 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.