chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt achy; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with IBUPROFEN for Ache NOS, Fever and Chills, at a dose of 1 UNK. At the time of the report, PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient felt better a few hours later.
Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02 or 03 sleeping clothes all wet-she had to change her clothes, Sunday-she feels drained, She laid in bed Saturday & Sunday drank water and took Motrin.  Monday-too weak to work.  Body aches, headache.  Monday severe ABD cramps-heating pad to help/nauseated.  Tuesday diarrhea starts.  Wednesday-left side of her back-pain-diarrhea & Tired.  No SOB.  Drinking Pedialyte and taking Motrin-she said IF she gets worse she will go to the Urgent Care-near her home.
Initial report received on 25-FEB-2014 from a consumer (the patient's wife): A 54-year-old male patient with no illness at time of vaccination and no pre-existing medical conditions had received an intramuscular injection of FLUZONE (Sanofi Pasteur Inc., batch number not reported) in the left deltoid in OCT-2013. 10 days after vaccination, in OCT-2013, the patient presented with fever and was seen in the MD office. The diagnosis was sinusitis. He was put on steroids for 1 week. He then developed pain, numbness, and weakness in the upper and lower extremities. He was seen by a Neurologist who made the diagnosis of "FLUZONE reaction". It has been 4 months since the vaccine was administered and the patient was still having symptoms. There has been some improvement in the lower extremities, but he is still having symptoms in the upper extremities. Many tests were run but specific information was not provided. At the time of the report, the outcome was mentioned as "not recovered".
Pt experienced swelling and a small lump immediately upon injection, pt states no previous reaction to flu vaccine.
Loss of taste 10 days following second dose of Moderna COVID-19 vaccine.  For 10 days after second dose he experienced heightened taste and then overnight he loss all sensation of taste.  Several weeks prior to his 3rd dose of Moderna on 8/16/21 he had noticed some improvement in taste.  On 8/17/21 pt lost all taste again.  Pt states history of some decreased taste and smell months prior following a tooth extraction.
Continuous headache in the middle frontal part. Jaw and tooth pain, aching feeling in my teeth. Occasional episodes of shortness of breath.
undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines;   This literature marketed report has been received from authors of published article referring to a 2.5 years old male patient. The patient was a full-term male infant born with undetectable T cell Receptor Excision Circles (TRECs) remained asymptomatic with decreased absolute T cells (895 cells/micro-L) and appropriate mitogen response by age 2 months.       On unknown dates, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided). By 2.5 years, he developed hypotonia, recurrent respiratory infections, and chronic diarrhea. On unknown dates (reported as "concurrently"), his labs demonstrated absolute T-cell lymphopenia (708 cells/micro-L), immunoglobulin G (IgG) deficiency (235 mg/dl) and undetectable titers to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). Unexpectedly, he demonstrated a persistently elevated mean cell volume (MCV) (92.3 cells/micro-L) and elevated serum homocysteine (20.6 micro-mol/L). The outcome of the event was unknown. The causality assessment was related.  A copy of the published article is attached as further documentation of the patient's experience.
12/26/2020, THREE DAYS AFTER RECEIVING THE MADERNA COVID 19 VACCINE MY LYMPH NODES UNDER MY LEFT ARM PIT AND TO THE RIGHT OF MY LEFT ARM SWELLED TO GOLF BALL SIZE. TODAY IS 1/11/2021, I AM EXPERIENCING SEVERE PAIN UNDER THE LEFT ARM PIT, IN THE LEFT UPPER BREAST AND IN THE  LEFT UPPER BACK. I HAD A MAMMOGRAM AND ULTRASOUND TODAY. THE RADIOLOGIST SAID THE TESTS WERE NORMAL.  HOWEVER MY LYMPH NODE IS SWELLED UP 2 TIMES THE REGULAR SIZE. HE ADVISED NO ANTIBIOTICS. TO TAKE OVER THE COUNTER PAIN RELIEVERS AND APPLY HEAT FOR RELIEF.
Possible undiagnosed allergic reaction to MMR. Developed rash, swollen glands, Temp F104-105 within 48 hours of receiving vaccine. Gave Motrin, child recovered without seeing doctor.
Patient was administered second moderna  covid 19 vaccine on 3/11/21 , and due date was 3/15/21
pt exp rash all over body several wks ago following dose 2 of Engerix-B;
Pt. received the Flu vaccine on  Monday 10/23/23, stating no know allergies. C/o getting a rash(hives) on legs and face on Wednesday, denies SOB or throat tightness. states  she is taking Benadryl and hydrocortisone cream at home with some relief. she was advised to take a Pepcid, and go to urgent care if symptoms worsen. She is working from home and declined a video visit.
Severe pain in left shoulder and inability to raise arm.  Ultimately, if stopped hurting after about a week.
diarrhea, gastric distress, severe stomach cramps 12 days, severe headache 5 days, neck muscle spasms, chesst pain, fever blister, still persists, doctor virtual visitii
5 days after receiving flu vaccine my wife developed the onset of erythema nodosum like lesions on her right arm and pretibial areas. There were also a few lesions on her face. After 10 days or so they have begun to clear but are still present 20 days after the shot. There was surrounding erythema and some pruritis. I also took a digital picture of the lesions on the pretibial area.
Woke up 3:45am because rolled over on very sore arm, stood up and felt nauseated, blacked out, dizzy, chills, couldn?t get warm, sweating. Headache by 8am, no fever. Body aches.
Fever, headache, chills, sore joints, tiredness for approximately 24 hours.
Symptoms: Vomiting, body aches, chills Time course: 10-12 hrs after vaccination Treatment: None.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-HCP (Office Staff). This case is linked to cases 2019SA089010 and 2019SA088988 (same reporter). This case involves a 24 months old patient who received 0.5 mL dose of vaccine DAPTACEL (lot C5171AA, Exp. Date- 23-Mar-2019) via unknown route in unknown administration site on 24-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse reactions. 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. Documents held by sender: none.
Vaccine given on 07/01/19. Redness and itching at the injection site, fever, and vomiting started on 07/02/19. Patient returned to office on 07/03/19. Site had a 4x5 cm area of erythema with a papular rash. On 07/04/19 vesicles appeared. On 07/05/19 patient returned to the office with 13x12 cm area of erythema to the medial aspect of the right leg with intact vesicles in a semicircular/ lunar configuration on the left side of vaccine site.
This spontaneous report was received from a licensed practical nurse, and refers to a 13 year old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with her second dose of GARDASIL 9, intramuscular, lot # R027577, for prophylaxis. The reporter stated that the patient received the second dose fifteen months after the first dose (inappropriate schedule). No adverse effects were reported.
Patient came into pharmacy on 8/11/18 to report adverse reaction to his second dose of SHINGRIX received on 8/8/18. On the evening of 8/8/18 he experience soreness in the left deltoid muscle and full body coldness with increased urination. He declined having a fever. He said none of these reactions other than arm soreness happened with the first vaccine.
Herpes outbreak that turned into viral meningitis and severe UTI. 9 days in the hospital on IV medications. Transported by ambulance to hospital in, 3 hours away and out of state. Initial symptoms were vaginal burning/itching followed by rash. Low grade fever, inability to urinate. Finally, severe, debilitating headache, stiff neck, severe pain between my shoulder blades.
This case was reported by a consumer via call center representative and described the occurrence of tremor in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 27th August 2018 at Public health department). On 1st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a day after receiving SHINGRIX, the patient experienced tremor, red rash, sleeplessness, chills and discomfort. The patient was treated with bacitracin, neomycin, NEOSPORIN and Alcohol. On an unknown date, the outcome of the tremor, red rash and sleeplessness were recovered/resolved and the outcome of the chills and discomfort were unknown. It was unknown if the reporter considered the tremor, red rash, sleeplessness, chills and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. About 5 hours after she got the shot her whole body went on alert and she could not sleep. This lasted for about 24 hours. The first night she also had chills and started shaking like she had convulsions for a few seconds until she got under some warm stuff. A week later she got a red mark on her face, about 1 inch long, which had some discomfort underneath. She treated it with NEOSPORIN and it went away after about 1 week. Then she to a round, dark, bright red spot on her right arm that was open and about 1 by 4 inch wide she cleaned it with hydrogen Peroxide and puts NEOSPORIN on it. It was getting better, but still looked like it was open. She wiped it with alcohol and thought it would burn, but it did not. This seems to had dried it up some. The reporter agreed to be contacted for follow up.
Patient reported radiating pain down her arm for several weeks after vaccination. She also said her injection site swelled up a little. She did have a pinched arm in her neck at the time of vaccination and takes pain medication for other issues. She did not report any loss of range of motion. When I talked to her, she said her pain had mostly resolved. I apologized and recommended that she follow up with her doctor. I saw that she had been to the emergency room for pain, I do not know if it was due to her pinched nerve in her neck or not. She did not say that her doctor said the issue was due to the vaccination.
Client came to the clinic for vaccines on 2/4/2019. Assessment was done as routine and we asked twice if she was pregnant, asked by both nurses at the clinic. Client said she was not. Then client called on 2/26/2029 to say that she found out she was six weeks pregnant.
Dizziness, syncope, systemic pain (muscular, bone, headache), extreme fatigue, congestion, runny nose, pruitis.
pain moved to the front and rear of the upper arm/pain several places above my elbow; pain in my left arm near the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain moved to the front and rear of the upper arm/pain several places above my elbow) and VACCINATION SITE PAIN (pain in my left arm near the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain moved to the front and rear of the upper arm/pain several places above my elbow) and VACCINATION SITE PAIN (pain in my left arm near the injection site). At the time of the report, PAIN (pain moved to the front and rear of the upper arm/pain several places above my elbow) and VACCINATION SITE PAIN (pain in my left arm near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.   Reporter did not allow further contact
Right should , bicept and arm experienced pain when I moved it, raised  it, extended the are to twist open a door knob.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a physician, 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 25-JUL-2017, a pharmacist administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 29-AUG-2017, the patient was treated by healthcare providers (unspecified healthcare professionals) 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 patient's 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 (not further specified); lost wages; loss of earnings capacity; and other losses and damages as a result of shingles and other zoster-related injuries. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to fifteen patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 29-AUG-2017 through 18-SEP-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N010497 with an expiration date on 15-JAN-2020 and lot# M042853 with an expiration date on 17-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    This case was created for 7th patient of 56 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
After receiving Moderna vaccine patient c/o shortness of breath, lightheadedness, throat swelling and and feeling faint.  Patient received Epi pen 0.3 mg IM, placed on O2 and given 2 puffs of Albuterol inhaler while calling 911.  Patient was taken to hospital by 911.
Initial misuse report received from a healthcare professional on 26 SEPTEMBER 2013. A patient ad received 0.5 ml of FLUZONE, intradermal. It's an incorrect route of vaccine administration. No adverse event was reported. List of documents held by sender: None.
patient received dose from vial past the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vial past the 30-day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vial past the 30-day use by date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vial past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not reported.  On 13-Sep-2021, the vial was initially stored in the refrigerator.  The dose was administered after 30-day use by date or after manufacturer date of expiry. The vial did not undergo any temperature excursions.
Body ache, headache, fever 12 hours after the vaccine. Had some sort of allergic reaction (facial swelling and red eyes)
I found out I was pregnant 2 days after the 2nd dose was administered.  I would have been 3 weeks and 3 days pregnant at the time.  My husband and I are both perfectly healthy and had been trying for 2 years to get pregnant.  At our 20 week anatomy scan 5/24 it was discovered our baby has bilateral cleft lip/palate.  I was not  taking any medications around the time, nor smoking or drinking alcohol.  I do not have diabetes.  No one in our family has history of cleft lip/palate.  I was taking a prenatal vitamin daily, even for years before discovering we were pregnant.
At injection, some vaccine trickled out of the arm. Increased soreness and swelling that day and for the next few days resolved on their own. Same day as injection, I experienced mild nausea and dizziness. Resolved with rest and time by the end of the day. On 1/23, my left arm at the injection site was swollen, hot, and red. Large red area present that grew bigger the next day. No other symptoms. Was prescribed Keflex on Sunday (1/24)  by covering HCP (telephone call). Saw my dermatologist for a scheduled appointment who said it was not cellulitis but a delayed allergic reaction. I stopped Keflex on 1/26. On 1/27, symptoms have improved. Small circumference, less redness, and swelling.
3/2/12 chest congestion body aches, fever. 3-2-12 CXR PA & LAT right middle lobe pneumonia.
This client  had vaccines registered on the local website as being given on January 2022  so we confirmed this with the client  Client verified that he did not have  a vaccine since that date  So we were ok to vaccinate  After vaccine was given  a new record became available which shown client last vaccine date was 9/22/22 one month prior?  Client did not remember getting this vaccine  Client?s provider also did not remember this senior citizen receiving this last dose on 9/22/2022 This Client was observed for 30 minutes with no adverse response
Headache; Sore at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Persistent atrial fibrillation, Arteriosclerotic coronary artery disease, Acute respiratory failure with hypoxia. ED Visit and hospital admission. this visit was within 6 weeks of receiving the COVID vaccine.
Swollen at area of injection that spread down the arm and around- area was hot to the touch and sore.