chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient has high blood pressure that was controlled.). Concomitant products included LISINOPRIL for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 03-Feb-2021, PYREXIA (Fever) and CHILLS (chills) had resolved.            Patient uses concomitant drugs that was cartia, and thyroid medicine.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-384477 (Patient Link).
Chills-shaking, couldn't get warm even wrapped in blankets and on heating pad.  11:45 pm 3/2/21 to 3/3/21   9:00 pm+ Fever - 101.5  3/3/21  3 hours  in morning and took Ibuprofen 200 mg which stopped the fever Itching over entire body with no marks. 3/31 - same time as fever - lasted about 6 hours - itching turned into pins and needles feelings all over finally took Benadryl - 2 OTC doses 6 hours apart Joint and muscle aches especially strong in areas of body where I had past injuries -lasted 4-5 days Red patch on  inside left arm below injection site- appeared 3 days after vaccination - no bumps or outbreak -finally  used trimcinolone 0.5% cream 2X (which I had from previous insect bites event) and it disappeared Fatigue  which lasted  5 days.
Alopecia, raynauds, joint pain, elevated liver enzymes, livedo reticular, UTI, bladder & kidney infection
Right arm swelled.  Was red from elbow up to shoulder and hot to the touch.  Body aches and slight fever.
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt arrived to recieve Pfizer vaccine. Pt reported that they experience fainting with vaccines and blood draws. Vaccine given. Mother of pt present. Pt passed out and was not responding to name. Pt regained clear vision and was able to respond normally within 5 minutes. Pt stayed and left with mother after 30 minutes.
Approximately 10 days after receiving my booster shot I got full-body hives located in most of the folds of my skin (under the belly, near the groin, under the armpits, behind the ears). The hives have been incredibly itchy. I have been taking Zyrtec and Benadryl since 12/31 (it is now 1/4) as well as topical Benadryl anti-itch cream. The majority of the hives have went away but some still remain on my face, scalp, palms of my hands, top of my feet, inner thigh, elbows, and side of torso. I hope that all of the remaining hives disappear by the end of the week (1/8).
A pharmacy technician in training administered the vaccination under the Emergency authorization . He prematurely withdrew the needle from her arm and what appeared to be most of the dose leaked out and ran down her arm. She felt like she did not receive her dose and wanted to be revaccinated. I (pharmacist) decided to revaccinate the patient and I administered the vaccine. She waited in the observation area for 15 minutes with no adverse events. She came to see me on 3/24 and reported that since that first dose she has been experiencing fatigue, body aches, tightness of chest and occasional headache. These symptoms began about 2 hours after she returned home from her first vaccination dose and are currently still occuring. I contacted Moderna to discuss the adverse events and they will be contacting the patient to discuss. I also advised patient that she may want to contact her health care provider.
Skin redness at injection site and down to the elbow.  Patient stated she self treated with benadryl and hydrocortisone cream.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 11-OCT-2012 13:11, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
bronchitis, inflamed sternum, pains & swelling in joints of hands knees & toes severe rheumatoid arthritis; reaction started p/flu shot;
Information has been received from a pharmacist concerning a 65 year old female who is the mother of an other healthcase professional in the same pharmacy. On 22-APR-2009 the patient was vaccinated with ZOSTAVAX (Merck). The patient experienced localized reaction like redness, pain and swelling on the same date after vaccination. This is one of several reports from the same source. Additional information has been requested.
Patient described the site of the injection being swollen, hot to the touch, and painful. Patient denies the reaction being systemic, itchy, or having a localized rash. Patient stated they were putting ice on it, advised for them to continue doing so. Advised, if the area is not improving, or getting worse, a visit to the doctor may be warranted.
Broke out with bumps on upper left side of my back, left arm and hand swelling and pain in left hand that continues and hasn't went away.
Within 30 minutes of vaccine, injection site began itching, swelling. Erythema of 8 cm. with minimal induration at actual injection site.
I recieved a dose of strong pain medication and the nurse alerted me that my arm that received the shot will be sore the next day.  I woke up after few hours due to the pain in my left arm which I received the shot.  I have been at home with severe pain and stiffness and soreness of my arm, neck and shoulder and it seems after a week it is not getting better.  I missed work during a very busy time.  The range of movement for the left hand that recieved the shot is very limited and kind of feel locked.  I am very frustrated as my doctor which on saw on Monday and called yesterday suggests only stronger pain medication.  I forgot the discomfort of the burn.  It seems no one can tell me what to do to feel better or how long it might take?  It is frustrating.  Most people who call express that they had discomfort for a couple days... I am feeling pain and stiffness for all these days...Do I have allergy?  I have been applying heated pad all day.
FLUMIST administered - 5 min. after adm, pt. felt lightheaded, unconscious, pupils dilated - seizure x 10-15 sec. with tremors head, arms, clenched jaw. No incontinence. Recovery within 10 min with O2 admin. BP 100/60 P-68 initial -> recovered 120/70. Sent to ER via ambulance, alert, oriented x 3.
PATIENT DEVELOPED A FEVER OF 102 F ON 11/16/19, SHE ALSO HAD DECREASED LEVEL OF ACTIVITY. FEVER CONTINUED THROUGH 11/17/19 THEN ON THAT EVENING MOM NOTED SMALL RED LESIONS, SOME WITH PUSTULES, ON CHEST/TORSO,  THESE SPREAD TO HER BACK, ARMS, NECK AND FACE. AS OF 11/18-19 SHE CONTINUES TO HAVE A FEVER 101-102, NEW LESIONS ARE BEING NOTED. WE WILL CONTINUE TO DO DAILY PHONE FOLLOW-UP.
2 weeks after vaccine I started experiencing eczema & psoriasis, specifically follicular eczema/psoriasis. Started off as little acne like breakouts on legs and started spreading. Now on face, arms, legs.
Nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Nose bleeding). At the time of the report, EPISTAXIS (Nose bleeding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not provided.
reported experiencing high fever; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 for covid-19 immunisation. On an unspecified date the patient experienced reported experiencing high fever. Description of the event, comment, or concern as provided by the reporter: Employees received the 2nd dose of the Pfizer COVID-19 vaccine. Following the dose said employees reported experiencing high fever to their employer. Outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Generalized weakness. Vitals were normal except BP was mildly low (96/60). Over several hours her strength gradually improved. She was admitted to the hospital on site for observation and neuro checks overnight.
Info has been received from a health professional concerning an 8 year old male, with no medical history and no allergies, who on 7/14/98 was vaccinated with a SC 1st dose in the left thigh of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that on 7/1/05, the pt developed a rash, with 80 lesions, scattered over his body. The pt was taken to the ER. He was afebrile and was given symptomatic treatment only. It was reported that the pt was recovering. No product quality complaint involved. Follow-up info from a health professional indicated that the pt's mother called the office on 7/5/05 and stated that she had a physician friend check the pt's rash that started on 7/3/05 and dx'd it as varicella. It was noted that there were approximately 80 vesicles on his back and chest with no fever. The lesions were all crusted over and the pt recovered on 7/5/05. Additional info is not expected.
Herpes zoster; Information has been received regarding a case in litigation from a lawyer concerning a currently 71 year old not married female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.    On 10-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, the patient experienced herpes zoster. The patient received an unspecified treatment.   The outcome of herpes zoster was unknown.     The reporter considered that the event resulted from Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
fever 104, Rt arm swollen from elbow up 1 1/2 size. red spot spread to size of hand. approx 7-8 cm. wrsit redness, rt. ankle swollen ,Mom gave advil on Friday,  called on call PMD  Sat. advised ice arm. give Benadryl. Fever gone still limping ankle, arm stil swollen.
Information has been received from a physician concerning a male anesthesiologist with a history of shoulder surgery in the past who on 30-NOV-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot# 663936/0508Y) subcutaneously into his tricep. Secondary suspect vaccination on the same day included a dose of RABAVERT intramuscularly in his deltoid in the same arm. On 30-NOV-2009 in the evening the patient experienced myalgia, arthralgia, anorexia and fever of 101F. On 01-DEC-2009, the patient's tricep was painful. The affected area was 5 to 8 inches and had redness and induration. The patient went to the emergency room and was given I.V. antibiotics (unspecified). On 03-DEC-2009, the pain was better but the induration was greater. He went to the emergency room on 03-DEC-2009 in the evening and was given vancomycin for a "possible staph and MRSA infection". On 04-DEC-2009, the swelling had increased but the pain had improved. The physician did not know if the patient had received PNEUMOVAX in the past. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. The physician considered arthralgia, anorexia, fever of 101F, reddened area on tricep was 5 to 8 inches, feeling "wiped out", possible staph and MRSA infection, swelling has increased, tricep had induration, tricep painful and myalgia to be disabling. Additional information has been requested.
Reaction started the day after booster.  Red, patchy hives that itch.  Hives continued to get worse the following two days.
Headache Reports "flushing", monitor observed redness in arm, neck, and face Narrative:  @1114Monitor observed redness in arm, neck, and face, VS: BP- 173/118 HR-100, @ 1130: BP- 165/107 HR-93, @1146: BP 174/109 HR-102. @1202: BP-166/112, 153/102 HR-105, reports "flushing", ice pack given. @1217: BP-144/91 HR-98 SPO2 96%RA. @1234: BP- 128/87 HR-88 SPO2 97%RA, still slightly flushed and redness resolved, employee able to go and will go home to rest. Stayed a total of 1hr and 15 mins for monitoring. Employee reported from the first dose "had a headache the next day in the morning but after taking ibuprofen, went away midday."
Menstrual cycle started  right at my 10 month of not having one for  seven days . Menstrual cycle for myself only last 3 to 5 days and was very painful ( Back and Breast tenderness ) I also have bruises on my upper right and left arm on my left thigh and on my right ankle round red circles
Tested positive for COVID on 4/26/2021. Recieved Monoclonal Antibodies.  Began to feel run down on 4/21/2021 and started to run a fever on 4/23/2021. Had a low grade fever (100.5) from the night of 4/21 through Sunday night 4/25.  Awoke Monday  4/26 and have been fever free since that time.  I have also been free of symptoms, except an occasional cough, since Monday 4/26.  I have also been experiencing a bout of what I believe is shingles on my back.  I have had an irritated spot on my back since March 19.  It is between my right shoulder blade and spine.(2" x 1..5") I treated it as a muscle cramp.  Occassionally, I would look at my back and I could see bumps but I passed these off as bug bites.  My back has itched and at times it stings.  Again I'm thinking muscle cramp, but it does feel like more nerve pain than muscle.  Yesterday, 4/29 it seemed to be more flared up.  There are no pustules, just bumps.  I had the Shingrix series 3/13/2019  and 9/20/2019. Because I am Covid positive, I cannot be seen by a doctor to confirm the shingles.  If I do have shingles, this would be two vaccine failures.
Immediately post vax, the pt developed a rash with red dots on lower extremities, then all over body with swelling. Treated with Benadryl and examined by MD.
Miscarriage  11/13/09 PCP Ultrasound and progress notes for DOS 11/09/09.  DX: Miscarriage.  Pt developed heavy bleeding and cramping on 11/08/09. The next morning the bleeding decreased. Ultrasound performed to confirm dating and viability.  According to the notes from midwifery center, pt had her first OB appt scheduled at time of loss.  She miscarried prior to appt, so info is limited.  Pt was about 11-12 weeks pregnant.
Vaccine was administered on 12/8/09. Mom started noticing an area of redness approx 24 hours after injection that became larger & hot. Pt's physician determines it was a site reaction to the DTAP vaccine.
Red, painful rash that got worse over the first 48 hours but has been getting better over the last 24. No other symptoms.
Developed 4cm red hive with central elevation.  Given 12.5 mg benadryl.  Observed for 1 hour.  No SOA.  Redness improved to 2 cm and no longer raised.  No known hx of allergy to chickens.  Has eaten eggs, given varicella without reaction.
Experienced side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Experienced side effects) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Experienced side effects). At the time of the report, ADVERSE EVENT (Experienced side effects) outcome was unknown. Not Provided           Concomitant medication information not provided.  Treatment information not provided.     Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021
Arrived via ambulance with reported unwitnessed falls over the weekend and possible pain.  Pt unable to verbalize specific pain.  States that she hurts all over. Admitted inpatient, switched to swingbed Hypokalemia AKI---Chronic kidney disease    Unwitnessed fall    2. Acute kidney injury (HCC)    3. Dehydration
Symptoms began 18 hours after vaccine and lasted 12 hours:  fever (101.7), joint pain, headache, myalgia, pain with deep breath.   I used acetaminophen  3 times.
Pt given injection approx 9:45am at 10:05am pt was feeling strange and she then fainted.  She had another fainting spell several minutes later.  Each spell lasted 2-3 seconds.  Her BP was quite low during each episode.
pt recvd vax; was dazed x 5 days p/vax;pt devel t approx 103 x 3 days;did not cry or display swelling at inject site;hlth care proveider was informed of the rxn at the 6mo well-visit;
Patient initially presented to ED on 8/29/21 with symptoms consistent with COVID-19 (loss of smell, cough, shortness of breath, fever, chills). Patient did test positive for COVID-19 on 8/29 and was discharged with orders to receive a Regneron infusion on 8/31/21. The patient did receive the infusion. The patient presented to ED again on 9/1/21 with chest pain and shortness of breath as well as headache. The patient was found not to have any evidence of PE and O2 sat 96%. The patient's headache was treated with dexamethasone and promethazine. The patient will be discharged home.
On 09/30/2022 I had a fever of 100.4 and body aches. At 12:30 AM in the morning on 10/01/2022 my fitness tracker alarm went off it was showing 110 BPM and I had a 101.5 temperature and a nasty headache as well.
Headache, Myalgia, Arthralgia, Nausea Vomiting, malaise
Patient was given a potential expired dose. The label per pharmacy was listed as 12/31/22. After investigation it was determined it was incorrectly labeled and the box should have stated 11/30/22 per pharmacy. The patient did not have a reaction or experience an adverse event.
This spontaneous report as received from a medical assistant refers to 4 year old male patient. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant therapy included sterile diluent (MRK). On 22-MAR-2018 the patient was vaccinated with expired dose of PROQUAD injection (lot # M038228, expiry date: 06-MAR-2018) (dose, frequency and route were not reported) for prophylaxis. The reporter confirmed that, the expired PROQUAD had no temperature excursions prior to being administered. No adverse effects reported. No product quality complaint was involved. Albumin status for PROQUAD is recombinant human albumin (rHA).
CHIEF COMPLAINT/REASON FOR VISIT Shortness of Breath     HISTORY OF PRESENT ILLNESS  Patient is an 80-year-old male with a history of aortic ectasia, hypertension, hyperlipidemia, hypothyroidism, prostate cancer, cervical spine fusion (2017) who presents to the Emergency Department for the evaluation of shortness of breath. The patient tested positive for symptomatic COVID on 09/23/2021. Six days ago after completing his school bus route, the patient noted that her lost his senses of taste and smell. He underwent COVID testing on 09/23, which returned positive. Four days ago, the patient underwent monoclonal antibody therapy and generally felt well. Three days ago, the patient developed new shortness of bre
Enlarged Lymph Node in the neck on the left side. I also had the expected flu-like symptoms with fever, body aches for about 72 hours following.
Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 7 months (7 months 26 days) old male patient who was vaccinated with 0.5 ml expired second dose of PENTACEL (PENTACEL Lot: of dry C50378A expiry: 12/07/2018 PENTACEL Liquid Lot: C50208A expiry: 06/30/2018) in the right thigh (route not reported) on 06-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE in right thigh for Immunisation; PREVENAR in left thigh for Immunisation; and ROTAVIRUS VACCINE for Immunisation on an unknown date. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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 the sender: None.
4 x 2 1/4 inch redness at site, itching, and pain three days after injection.  Area circled and Benadryl given.